[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,49,80,109,131,153,173,205,241,269,299,330,398,426,453,476,500,526,550,571,592,618,651],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100633228","paraffin-oil-for-preventing-tourniquet-related-skin-lesions-in-upper-extremity-surgery-100633228",false,"NCT07523958","Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery","Paraffin Oil for Preventing Tourniquet-Related Skin Lesions in Upper Extremity Surgery (PARA-TOUR RCT)","PARA-TOUR","IInclusion Criteria:\n\n* Age ≥18 years\n* Patients scheduled for elective upper extremity surgery requiring pneumatic tourniquet application\n* ASA physical status I-III\n* Body mass index (BMI) \\\u003C30 kg\u002Fm²\n* Ability to provide informed consent\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Known dermatological disease or existing skin lesion at the tourniquet application site\n* Allergy or sensitivity to paraffin oil or related substances\n* Severe systemic disease (ASA IV or higher)\n* Obesity (BMI ≥30 kg\u002Fm²)\n* Emergency surgery\n* Patients transferred to intensive care postoperatively\n* Development of major postoperative complications (e.g., hematoma, seroma, nerve injury, significant bleeding)\n* Inability to communicate or comply with study procedures\n* Withdrawal from the study at any time","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial aims to evaluate the effectiveness of topical paraffin oil application in preventing tourniquet-related skin lesions in patients undergoing upper extremity surgery. Pneumatic tourniquets are commonly used to provide a bloodless surgical field; however, they may cause skin complications such as erythema, edema, abrasions, blisters, and burns.\n\nIn this study, adult patients undergoing elective upper extremity surgery will be randomly assigned to either an intervention group receiving topical paraffin oil application in addition to routine protective dressing or a control group receiving routine care only. Skin integrity will be assessed immediately after tourniquet removal and at 30 and 60 minutes postoperatively using standardized skin assessment criteria.\n\nThe findings of this study are expected to contribute to the development of effective, simple, and cost-efficient strategies to prevent tourniquet-related skin complications and improve patient safety and postoperative comfort.",[27,28,29],"Pressure Injury","Skin Lesions","Skin Injury",[31,32,33,34,35],"Paraffin Oil","Tourniquet","Upper Extremity Surgery","Skin Injury Prevention","Randomized Controlled Trial","RECRUITING","2026-06-02",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":40},"2026-01-12",{"date":44,"type":21},"2026-07",{"name":46,"class":47},"Istanbul Medipol University Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100639651","nursing-competency-scale-in-pressure-injury-prevention-a-scale-development-study-100639651","NCT07590765","NURSING COMPETENCY SCALE IN PRESSURE INJURY PREVENTION: A SCALE DEVELOPMENT STUDY","Nursing Competency Scale in Pressure Injury Prevention: A Scale Development Study","NCSPIP","Inclusion Criteria:\n\n* Working as a nurse in the related institution\n* Voluntarily agreeing to participate in the study\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Not working as a nurse in the related institution\n* Not voluntarily agreeing to participate in the study\n* Incomplete completion of the data collection forms",true,{"count":59,"type":21},300,"OBSERVATIONAL","Pressure injuries remain an important patient safety problem and are associated with prolonged hospitalization, increased healthcare costs, pain, and reduced quality of care. Nurses play a key role in the prevention of pressure injuries through risk assessment, skin care, positioning, nutritional management, and evidence-based preventive interventions.\n\nThe purpose of this study is to develop and evaluate the psychometric properties of the Nursing Competency Scale in Pressure Injury Prevention. The scale is intended to assess nurses' competencies regarding pressure injury prevention in line with updated international guidelines. The study will be conducted with nurses working in a training and research hospital in Türkiye.\n\nThe scale development process will include item generation, expert evaluation for content validity, pilot testing, exploratory factor analysis, confirmatory factor analysis, criterion validity, internal consistency analysis, and test-retest reliability assessment.",[27,63],"Nursing Competency",[27,65,63,66,67,68,69],"Pressure Injury Prevention","Scale Development","Psychometric Evaluation","Nurses","Medical Device-Related Pressure Injury","NOT_YET_RECRUITING","2026-05-10",{"date":73,"type":40},"2026-05-15",{"date":75,"type":21},"2026-05-20",{"date":77,"type":21},"2027-01-30",{"name":79,"class":47},"University of Yalova",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100605141","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-chronic-pressure-ulcers-100605141","NCT07158658","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Pressure Injury\u002FUlcer located on the pelvis or lower extremity\n3. Subject has a Pressure Injury\u002FUlcer Stage 2 or 3 without infection\n4. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit\n5. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion\n6. Index ulcer has a depth of \\> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg\n7. Pressure Injury\u002FUlcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit\n8. Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to the first treatment visit\n9. Index ulcer is free of infection prior to the first treatment visit and during screening phase.\n10. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n11. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit\n12. Subject is able and willing to follow the protocol requirements\n13. Subject had signed informed consent\n14. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing in the opinion of the investigator\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>14 days duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to the first treatment visit\n11. Pressure Injury\u002FUlcer of Stage 4 or active osteomyelitis\n12. Wound depth with visible exposed bone\n13. HBOT within 14 days prior to the first treatment visit\n14. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n15. Index ulcer suspicious of neoplasm in the opinion of the investigator",{"count":88,"type":21},10,[24],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers",[27],[93,94,95,96,97],"Chronic Wounds","Wound Medicine","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","Cellular, Acellular, Matrix-like Product (CAMP)","2026-05-05",{"date":100,"type":40},"2026-05-06",{"date":102,"type":40},"2025-12-01",{"date":104,"type":21},"2027-01-01",{"name":106,"class":107},"NuScience Medical Biologics, LLC","INDUSTRY",2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":48},"100634239","effectiveness-of-a-combined-aloe-vera-peppermint-gel-on-prevention-pressure-injuries-among-intensive-care-unit-patients-100634239","NCT07537101","Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients","Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial","APG-PI","Inclusion Criteria:\n\n1. ICU patients aged 18 years or older.\n2. Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.\n3. Unconsciousness, being under sedation or assisted ventilation.\n4. Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-14.\n5. No Diarrhea, serum Albumin level below 3.5 g\u002Fdl, no edema.\n6. No limit of changes in body position with multiple injuries.\n7. Family consent to participate in the study.\n8. The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.\n9. All patients receiving standardized care (repositioning and pressure-relieving mattress).\n\nExclusion Criteria:\n\n1. Family's unwillingness for the patient to continue participation\n2. Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.\n3. Spinal cord injury cases\n4. death or patient transmission in less than 48 hrs. after admission to the ICU.",{"count":118,"type":21},40,[24],"The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients.\n\nDoes applying this natural gel reduce the incidence of pressure injuries compared to standard care?\n\nparticipants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.",[27],"2026-04-25",{"date":124,"type":40},"2026-04-30",{"date":126,"type":21},"2026-06-05",{"date":128,"type":21},"2027-04-20",{"name":130,"class":47},"Ali Abd-Alredha Hussein",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100586682","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-pressure-injuries-100586682","NCT06918548","Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Randomized Controlled Multicenter Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Pressure Injury\u002FUlcer located on the pelvis or lower extremity\n3. Subject has a Pressure Injury\u002FUlcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a Pressure Injury\u002FUlcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization\n5. Subject has a Pressure Injury\u002FUlcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has a Pressure Injury\u002FUlcer Stage 2, 3, and 4 without infection or clinically visible exposed bone\n7. Index ulcer is a minimum of 1cm2 and a maximum of 25cm2 at first treatment visit\n8. Index ulcer has a maximum depth of 1cm at first screening visit\n9. Pressure Injury\u002FUlcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 14 days prior to randomization\n10. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization\n11. Index ulcer is free of infection prior to randomization and during screening phase.\n12. Index ulcer is free of necrotic debris prior to \\[insert product\u002Fdevice\\] application\n13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n15. Having a Mini Nutritional Assessment Score of 12 or higher indicated a normal nutritional status\n16. Subject is able and willing to follow the protocol requirements\n17. Subject had signed informed consent\n18. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Pressure Injury\u002FUlcer of Stage 4 grade with active osteomyelitis or exposed visible bone\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":139,"type":21},148,[24],"This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.",[27],[144,94,97,95,96],"Chronic wounds","2026-04-06",{"date":147,"type":40},"2026-04-07",{"date":149,"type":21},"2026-07-01",{"date":151,"type":21},"2028-05-01",{"name":106,"class":107},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100631110","predictive-validity-and-clinical-utility-of-an-ultrasound-based-quantitative-risk-score-for-pressure-injury-in-critically-ill-patients-100631110","NCT07496411","Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients","Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients: A Two-Phase Sequential Study","Phase 1: Tool Development and Validation (Observational)\n\nInclusion Criteria (Phase 1):\n\n1. Age \\> 18 years.\n2. Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours.\n3. Intact skin in the sacrococcygeal region within 24 hours of ICU admission.\n4. Provision of signed informed consent.\n\nExclusion Criteria (Phase 1):\n\n1. Pregnant women or children.\n2. Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound.\n3. Clinical instability preventing lateral repositioning for ultrasound.\n4. History of major sacrococcygeal surgery or severe trauma.\n5. Life expectancy \\\u003C 48 hours. Phase 2: Randomized Controlled Trial (Interventional)\n\nInclusion Criteria (Phase 2):\n\n1. Meet all the general inclusion criteria from Phase 1.\n2. Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results.\n\nExclusion Criteria (Phase 2):\n\n1. Meet all the general exclusion criteria from Phase 1.\n2. Previous participation in Phase 1 of this study (to maintain independent samples for the RCT).\n3. Current participation in other interventional trials that may impact pressure injury outcomes.",{"count":161,"type":21},390,[24],"Pressure injuries are a common and serious complication for critically ill patients in the intensive care unit (ICU). Early and accurate identification of high-risk patients is crucial for effective prevention. This two-phase sequential study aims to evaluate a new, objective assessment tool: an ultrasound-based quantitative risk score.\n\nPhase 1 is an observational study designed to test the predictive validity of this ultrasound score. Researchers will use bedside ultrasound to examine tissue integrity and determine how accurately the score can predict the development of pressure injuries. Phase 2 is a pilot randomized controlled trial. In this phase, patients will be randomly assigned to receive either standard preventive care or a targeted nursing intervention guided by the ultrasound score. The primary goal is to assess the clinical effectiveness of this score-guided intervention in reducing the occurrence of pressure injuries and improving nursing care for critically ill patients.",[27],"2026-03-31",{"date":145,"type":40},{"date":168,"type":21},"2026-03-20",{"date":170,"type":21},"2027-07-01",{"name":172,"class":47},"Ruijin Hospital",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100628052","using-music-during-wound-care-among-seniors-with-pressure-injuries-100628052","NCT07456618","Using Music During Wound Care Among Seniors With Pressure Injuries","Investigating the Use of Music During Wound Care","Inclusion Criteria:\n\n* 60 years or older\n* Has a stage II, III, or IV pressure injury\n\nExclusion Criteria:\n\n* Designated as end of life and\u002For has a Kennedy terminal pressure injury\n* Has an unstageable pressure injury\n* The pressure injury has necrotic tissue or necrotic bone present\n* The pressure injury is infected\n* The pressure injury is caused by a medical device in that area\n* Severe to profound hearing loss that is not corrected by a hearing aid or other assistive hearing device.","60 Years",{"count":182,"type":21},50,[24],"Pressure injuries (also known as pressure wounds or bed sores) are increasingly common among older adults living in care homes. These wounds often require regular dressing changes, which can be uncomfortable for some.\n\nThe researchers believe that listening to music during wound care may have an effect on pain, wound healing, and the overall wound care experience, compared with wound care without music.\n\nThe goal of this clinical study is to test this idea by examining whether listening to music before and during wound care is linked to differences in pain, wound healing, and the overall wound care experience in older adults with pressure injuries.\n\nThe main questions this study aims to answer are:\n\nDoes listening to music before and during pressure injury care affect pain during wound care? Does listening to music before and during pressure injury care affect how pressure injuries heal over time? Does listening to music affect the overall experience of pressure injury care? Researchers will compare wound care with music to wound care without music to better understand whether music makes a difference.\n\nThe study will take place in eleven long-term care homes in Ontario. Participants will be residents aged 60 years and older who have a stage II, III, or IV pressure injury and who are already receiving regular wound care as part of their usual care. This study will not include residents who have infected or necrotic wounds, or who are at the end of life.\n\nParticipants will continue to receive the same wound care they would normally receive. Some homes will include music during wound care, and some homes will not.\n\nParticipants in homes using music will:\n\nListen to a playlist of music they personally enjoy for about 15 minutes before wound care begins Continue listening to the music during the wound care procedure Be able to change the volume or stop the music at any time Participants in homes not using music will receive the same standard pressure injury care without music.\n\nInformation for the study will come from clinical records that nurses already complete during routine wound care, such as notes about pain and wound healing. Staff involved in playing the music will also complete a short questionnaire about their observations of the wound care experience. Photos of wounds that are already taken as part of usual care may be reviewed to look at healing over time.\n\nParticipants may take part in the study for up to six months or until their wound has healed. Taking part is voluntary, and participants or their decision-makers can choose to stop at any time. The study does not change the medical care participants receive.",[186,27,187],"Pressure Injuries","Pressure Ulcer (PU)",[189,27,190,191,192,193,194],"Pressure Ulcer","Music","Wound Care","Long-Term Care","Aged","Quality of Life","2026-03-03",{"date":197,"type":40},"2026-03-06",{"date":199,"type":21},"2026-04-01",{"date":201,"type":21},"2027-06-01",{"name":203,"class":47},"McMaster University",11,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":215,"studyType":60,"phases":4,"briefSummary":216,"conditions":217,"keywords":224,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100458003","myriad-augmented-soft-tissue-reconstruction-registry-100458003","NCT05243966","Myriad™ Augmented Soft Tissue Reconstruction Registry","Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures","MASTRR","Inclusion Criteria:\n\n* Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan\n* Male or female patients aged 18 years or above\n* Patients where Matrix and\u002For Morcells were used as part of their soft tissue reconstruction procedure\n* Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule\n\nExclusion Criteria:\n\n* Patients with known sensitivity to ovine (sheep) derived material\n* Patients with full thickness ('third degree') burns\n* Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)\n* Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study\n* Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment\n* Pregnant or lactating women\n* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study",{"count":214,"type":21},800,"12 Months","This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.",[218,219,220,221,222,223,27],"Abdominal Wound Dehiscence","Necrotizing Soft Tissue Infection","Lower Extremity Wound","Pilonidal Sinus","Anal Fistula","Hidradenitis Suppurativa",[225,226,227,228,229,230],"Soft tissue reconstruction","Limb salvage","Extracellular matrix","Soft tissue reinforcement","Wound reconstruction","Regenerative medicine","2026-02-17",{"date":233,"type":40},"2026-02-19",{"date":235,"type":40},"2022-01-10",{"date":237,"type":21},"2029-01",{"name":239,"class":107},"Aroa Biosurgery Limited",13,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":57,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100616788","digital-twin-haptic-integrated-mixed-reality-simulation-100616788","NCT07310160","Digital Twin-Haptic Integrated Mixed Reality Simulation","Development of a Digital Twin-Haptic Integrated Mixed Reality Simulation for Pressure Injury Management","DT-HIMRS","Inclusion Criteria:\n\n* Nursing students enrolled in the Fundamentals of Nursing course.\n* Students who achieved a score of 50 or higher in the Fundamentals of Nursing course.\n* Students who voluntarily agree to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Students with any communication barriers that may prevent participation or comprehension.\n* Students with balance disorders (e.g., vertigo) or other medical conditions that could interfere with participation in the simulation.\n* Students who fail to attend pre-test, post-test, or follow-up assessments.\n* Students who do not participate in or complete the assigned simulation intervention.",{"count":250,"type":21},130,[24],"The responsibility for the management of pressure injuries belongs to nurses; the development of pressure injuries indicates that nursing care is not adequate. Pressure injury management should be addressed starting from undergraduate education in line with current guidelines. However, programs in which traditional education methods are used in pressure injury management are insufficient. Therefore, pressure injuries should be addressed with a structured simulation practice integrated with advanced technological methods. Any study using mixed reality in pressure injury management was not found in the literature. There is a study using augmented reality with a smartphone to measure wounds and a study examining the effectiveness of augmented reality in leg ulcer care. The use of mixed reality simulation in pressure injury management is one of the unique values of the project. Within the scope of the project, anchoring and monitoring physical objects in all application steps in pressure injury management and creating a digital twin is the most important original value of this project, which is that the student is immersed in the virtual reality environment in real-time and experiences all the processes physically-haptically. The digital twin-haptic integrated mixed reality simulation proposed in this project will contribute to the pressure injury literature and education by increasing the retention of information in memory and providing a realistic experience to the student, as it appeals to both visual, auditory, and tactile senses. The main aim of this project is to develop a digital twin-haptic integrated mixed reality simulation in pressure injury management and to compare the effect of the developed digital twin-haptic integrated mixed reality simulation and the high reality simulation in the institutional infrastructure on the students' knowledge level, skill performance, perceived learning level, satisfaction, and confidence level in learning. The project is planned as a randomized and comparative type and will last 24 months. A total of 130 second-year nursing undergraduate students will be stratified and randomized into the digital twin-haptic integrated mixed reality simulation and high-fidelity simulation groups based on their course grades and gender. Data will be collected using tests and scales. In terms of project management, the project has been handled in four phases with six work packages; in the first preparation phase, validity and reliability studies of the data collection tools, scenarios, and theoretical training module developed by the project team will be carried out, and participant randomization will be carried out. In the second phase, simulation laboratories will be prepared. In the third stage, the mixed-reality simulation software will be created and tested. In the last stage, pre-test application, training with the theoretical training module, simulation application, post-test, and follow-up will be carried out. Data will be analyzed using SPSS®23. All work to be carried out within the scope of the project is defined concretely and according to the workflow, and who\u002Fs will carry out each work is defined according to the field of expertise. All possible risks that may be encountered during the project have been foreseen, and measures for risk management have been prepared as Plan B. Within the scope of the project, importance was given to the use of the facilities, infrastructure, and equipment available in the institution. Within the scope of the project, the digital twin-haptic integrated mixed reality simulation will be developed entirely with national resources and registered. The mixed reality simulation software will be commercialized for educational purposes. In addition, with the use of the digital twin-haptic integrated mixed reality simulation program in the management of pressure injury, the quality of education in the field of health will increase, and the IT infrastructure of the training curricula will be supported, and a standard will be provided throughout the country, thus creating a sufficient and qualified workforce in this field. As a result of this qualified training, it is predicted that pressure injury rates will decrease and patient safety will increase in the long term. With the mixed reality simulation program, the leadership power of our country in the international arena, its potential, and recognition in the field of education and technology will be increased.",[27,254,255],"Simulation Based Learning","Nursing",[257,258,259],"haptic","mixed reality","digital twin","2025-12-29",{"date":262,"type":40},"2025-12-30",{"date":264,"type":21},"2026-02-02",{"date":266,"type":21},"2026-05-29",{"name":268,"class":47},"NEBAHAT BORA GÜNEŞ",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":298},"100556744","implementing-a-decision-support-tool-to-prevent-community-acquired-pressure-injury-in-spinal-cord-injury-sci-in-the-spinal-cord-injury-clinic-100556744","NCT06529094","Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic","CAPP-FIT","Inclusion Criteria:\n\nVeteran participant eligibility criteria include:\n\n* assigned provider in SCI clinic who is willing to participate in the study\n* has a scheduled appointment in the SCI clinic\n* ability to complete survey\n\nExclusion Criteria:\n\n* active diagnosis of dementia",{"count":277,"type":21},808,[24],"Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.",[281,27],"Spinal Cord Injury",[283,284,285,286,287],"prevention","spinal cord injury","pressure injury","Veteran","community","2025-11-12",{"date":290,"type":40},"2025-11-14",{"date":292,"type":40},"2024-11-01",{"date":294,"type":21},"2028-07-31",{"name":296,"class":297},"VA Office of Research and Development","FED",7,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":310,"conditions":311,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":108},"100607845","phase-4-zinc-oxide-vs-mebo-100607845","NCT07193849","Zinc Oxide VS MEBO","Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial","Inclusion Criteria:\n\n* Willing to participate.\n* KAMC cases in medical ward, neuroscience ward, and intensive care unit.\n* Newly cases diagnosed with second stage pressure ulcer according to the European pressure ulcer advisory panel\u002Fnational pressure ulcer advisory panel (NPUAP) guidelines.\n\nExclusion Criteria:\n\n* Not consenting to participate\n* Patients with suspected hypersensitivity reactions to any of the topical formulation's ingredients.\n* Either a category III or IV pressure ulcer.\n* Evidence of deep tissue injury (exudative drainage, purple or maroon localized area of discolored intact skin or blood-filled blister due to pressure damage).\n* Signs of wound infection (pus draining from the ulcer, a foul-smelling odour, tenderness, heat and increased redness in the surrounding skin and fever).\n* Patients who undertaking other therapies that could affect healing, such as corticosteroids, radiation therapy, or chemotherapy for cancer.\n* Heavy smoking (more than 20 cigarettes a day).\n* Concomitant chronic disease (e.g., diabetes mellitus or frank vascular disease such as Buerger's disease).\n* Patients who unable to continue the study because of death, discharge, or change in the care setting.",{"count":307,"type":21},76,[309],"PHASE4","randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.",[27,312,313,314,315],"Pressure Injury Stage 2","Bedsore","Pressure Ulcers Stage II","Pressure Ulcer, Buttock",[285,317,318,319],"pressure ulcer","MEBO","Zinc oixid","2025-09-22",{"date":322,"type":40},"2025-09-26",{"date":324,"type":40},"2023-12-31",{"date":326,"type":21},"2025-12-31",{"name":328,"class":329},"King Abdullah Medical City","OTHER_GOV",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":338,"targetDuration":340,"studyType":60,"phases":4,"briefSummary":341,"conditions":342,"keywords":360,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":48},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":339,"type":21},300000,"5 Years","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[343,189,344,345,346,347,348,349,350,351,352,353,354,187,355,27,356,357,358,359],"Diabetic Foot","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Leg Ulcer","Pyoderma","Peripheral Arterial Disease","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Diabetic Foot Ulcers (DFUs)","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[361,362,363,364,365,366,367,368,189,27,369,370,351,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Diabetic Foot Ulcer","Venous Leg Ulcer","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Advanced Wound Care","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Debridement","Standard of Care","2025-07-10",{"date":391,"type":40},"2025-07-16",{"date":393,"type":40},"2005-01-01",{"date":395,"type":21},"2030-01",{"name":397,"class":47},"U.S. Wound Registry",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":180,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":412,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":48},"100589472","the-influence-of-standardized-process-management-of-laryngeal-mask-airway-placement-based-on-pressure-monitoring-on-the-incidence-of-adverse-reactions-in-elderly-patients-during-the-perioperative-period-100589472","NCT06954857","The Influence of Standardized Process Management of Laryngeal Mask Airway Placement Based on Pressure Monitoring on the Incidence of Adverse Reactions in Elderly Patients During the Perioperative Period","Inclusion Criteria:\n\n* Age ≥60 years old\n* Non-cardiothoracic surgery and head and neck surgery\n* Elective surgery\n* ASA I-III grade\n* NYHA cardiac function class I-II\n* The operation time is expected to be ≥30 minutes and ≤2 hours\n* 18.5≤BMI (kg\u002Fm2) ≤24.9\n\nExclusion Criteria:\n\n* Change to emergency surgery\n* Difficult airway that can be predicted before operation, such as difficulty in opening mouth and limited neck movement\n* Loose teeth\n* Laryngeal obstruction, laryngeal edema, laryngeal abscess, acute airway inflammation, full stomach, acute abdomen, abdominal trauma, drug poisoning, gastrointestinal bleeding\n* Complicated with chronic obstructive pulmonary disease, asthma and other respiratory diseases\n* Allergic to laryngeal mask materials\n* Non-supine position\n* Inability to cooperate with the investigator for any reason\n* Taking other investigational drugs or participating in other clinical trials within 3 months before study entry\n* The investigators considered it inappropriate to be included in the study",{"count":405,"type":21},78,[24],"The laryngeal mask airway (LMA) is a supraglottic ventilation device designed according to human anatomy. It was developed in 1981 by Dr. Archie Boubrain in the United Kingdom to compensate for the deficiencies of tracheal intubation and mask ventilation. It has been widely used in clinical practice because of its simple operation, small airway stimulation, and hemodynamic stability. In 1990, LMA entered the Chinese market. In 1993, LMA was included in the American Society of Anesthesiologists guidelines for the emergency management of the difficult airway. In the past, tracheal intubation was the standard method of airway control during general anesthesia. In the past decade, the proportion of LMA ventilated general anesthesia has increased significantly in China and European and American countries. By 2022, the utilization rate of LMA in China climbed to 95.96%. With the continuous improvement and development of LMA, it can be used to establish safe airway management in special positions such as lateral position and prone position, long-term surgery and special site surgery.\n\nHowever, the wide application has also exposed some key problems. The lack of standardized process management of LMA placement may lead to improper placement, airway obstruction, laryngspasm, reflux, and aspiration during the application of LMA, which may cause a series of pulmonary and extrapulmonary complications. Studies have shown that many adverse events during LMA implantation may be related to LMA pressure monitoring. Inadequate pressure monitoring may lead to pressure imbalance, and improper pressure management may lead to poor coordination between LMA and pharynx. Coupled with the change in intraoperative position and postoperative transfer, the risk of postoperative sore throat and LMA displacement increases. Therefore, there is an urgent need for standardized process management, dynamic pressure monitoring and position adjustment during the use of LMA. The standardized management of LMA insertion involves the standardized selection, placement, maintenance management and transportation of LMA. Especially for the elderly population, LMA displacement is more likely to occur due to the atrophy of pharyngeal mucosa and muscle, weakened cough reflex, and decreased chest wall compliance, which increases the incidence of pulmonary and extrapulmonary complications. For elderly patients with atherosclerosis, LMA displacement and relatively high cuff pressure may compress the jugular and jugular veins in the neck and surrounding tissues, increasing the risk of stroke in elderly patients. Effective and safe anesthesia airway and respiratory management strategies during general anesthesia will directly affect the occurrence of postoperative pulmonary complications (PPCs) and the incidence of sore throat in elderly patients. Standardized management of LMA and continuous pressure monitoring and adjustment can improve the above adverse reactions.\n\nAt present, there is a lack of large-scale and reliable evidence-based medical evidence to evaluate the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients with high risk of pulmonary complications. Especially in the elderly population with a high incidence of PPCs, the safety, short - and long-term advantages and disadvantages of widespread use of LMA ventilation are still unclear. Therefore, it is particularly urgent to carry out the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients, and to further explore the appropriate range of laryngeal mask related pressure indicators. This study based on the concept of enhanced recovery after surgery (ERAS) can not only fill the current research gap, but also provide strong support for safe and efficient airway management in elderly patients during the perioperative period, and effectively promote the further optimization of clinical practice, which has extremely important clinical significance and practical value.",[409,27,410,411],"LMA","Elderly","Airway Management",[413,414,415,416,417],"Laryngeal Mask Airway (LMA)","Pressure Monitoring","Elderly Patients","Complications","ERAS","2025-07-06",{"date":389,"type":40},{"date":421,"type":40},"2025-05-09",{"date":423,"type":21},"2027-03-31",{"name":425,"class":47},"Xuanqi Yang",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":441,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":48},"100579103","effectiveness-of-platform-based-lateralization-therapy-in-reducing-interface-pressure-between-the-patient-and-the-support-surface-100579103","NCT06819943","Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface","PREVENT-ICU","Inclusion Criteria\n\n* Adult and elderly patients, aged 18 years or older;\n* Patients under controlled or assisted mechanical ventilation, not yet eligible for weaning.\n\nExclusion Criteria\n\n* Requirement of norepinephrine \\> 0.3 mcg\u002Fkg\u002Fmin or mean arterial pressure \\\u003C 60 mmHg, despite the use of vasopressor agents;\n* Cardiac arrhythmias or bleeding leading to hemodynamic instability;\n* Neurological diseases or symptoms;\n* Spinal cord injury, such as paraplegia;\n* Cardiac pacemaker dependence;\n* Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome;\n* Air leakage from chest drains, presence of pneumothorax or undrained subcutaneous emphysema;\n* Presence of pre-existing pressure injuries in bony prominences (sacral, occipital, scapular, or calcaneal) at admission;\n* Medical refusal to include the patient in the study.",{"count":434,"type":21},25,[24],"Pressure injury (PI) is characterized as damage to the skin and\u002For underlying tissues resulting from sustained pressure or a combination of pressure and shear forces between the patient and the support surface. Prolonged pressure is a well-established risk factor in the development of PIs. Frequent repositioning and routine patient care have been recognized for decades as integral components of PI prevention and treatment protocols.\n\nThe duration of interface pressure is as critical as its magnitude. When interface pressure exceeds the mean capillary blood pressure, blood flow can be compromised, leading to ischemia in affected areas, which may progress to necrosis if sustained over time. Furthermore, it is widely accepted in the literature that tissue becomes at risk when interface pressure exceeds 30 to 32 mmHg.\n\nIn this context, continuous lateral rotation therapy (CLRT) offers a potential alternative for managing critically ill patients. CLRT involves continuous mechanical rotation of the patient in the lateral plane. However, its effects on skin integrity remain poorly understood. Despite the rationale behind and widespread recommendation of repositioning, the lack of robust evaluations on how repositioning impacts interface pressure creates uncertainty, underscoring the need for high-quality trials to assess different strategies for implementation.\n\nAlthough lateralization is a pragmatic strategy for preventing pressure injuries, its use in critically ill patients requires an integrated assessment of respiratory, hemodynamic, and gastroesophageal effects. Therefore, this study proposes an innovative approach by evaluating, for the first time, the effectiveness of automated postural change with simultaneous monitoring of tissue integrity, pulmonary function, cardiovascular stability, and gastroesophageal protection. The aim is to optimize pressure injury prevention, improve pulmonary mechanics, ensure hemodynamic stability, and preserve gastroesophageal safety in critically ill patients.",[438,27,439,440],"Respiratory Insufficiency","Intensive Care Medicine","ARDS",[442,443],"Continuous Lateral Rotation Therapy","Rotation Therapy","2025-06-17",{"date":446,"type":40},"2025-06-22",{"date":448,"type":40},"2024-06-01",{"date":450,"type":21},"2027-10",{"name":452,"class":47},"University of Sao Paulo General Hospital",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":48},"100592911","phase-4-evaluating-several-cellular-acellular-and-matrix-like-products-camps-and-standard-of-care-versus-matched-standard-of-care-controls-in-the-management-of-nonhealing-pressure-ulcers-100592911","NCT06999590","Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrixlike Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers","Inclusion Criteria:\n\n1. The potential subject must be at least 18 years of age or older.\n2. The potential subject must agree to attend the weekly study visits required by the protocol.\n3. The potential subject must be willing and able to participate in the informed consent process.\n4. The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).\n5. At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post-debridement with the imaging device.\n6. The potential subject has adequate off-loading of the ulcer.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 3 months.\n2. The potential subject's target ulcer is not a pressure ulcer.\n3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n4. The target ulcer exposes tendon or bone.\n5. The target ulcer has undermining or tunneling.\n6. There is evidence of osteomyelitis complicating the target ulcer.\n7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n9. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n10. The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n11. The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n12. The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n13. The potential subject has end stage renal disease requiring dialysis.\n14. The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n15. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n16. The potential subject has a malnutrition indicator score of \\\u003C17 as measured on the Mini Nutritional Assessment.",{"count":461,"type":21},500,[309],"The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.",[189,465,466,27],"Ulcer","Ulcer, Pressure","2025-06-03",{"date":469,"type":40},"2025-06-05",{"date":471,"type":40},"2025-05-20",{"date":473,"type":21},"2027-05",{"name":475,"class":107},"Tiger Biosciences, LLC.",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":57,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":485,"conditions":486,"keywords":490,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":48},"100585910","adaptation-of-the-intensive-care-unit-specific-pressure-injury-risk-scale-to-turkish-raps-icu-100585910","NCT06908512","Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)","Turkish Adaptation, Validity and Reliability of the Intensive Care Unit-specific Pressure Injury Risk Assessment Scale","Inclusion Criteria:\n\n* 18 years of age or older,\n* Staying in the Intensive Care Unit for at least 1 day,\n* Agreeing to participate in the study by themselves or a family member.\n* Volunteering to participate in the research\n* Full orientation and no psychiatric problems\n\nExclusion Criteria:\n\n\\- Having communication problems",{"count":484,"type":21},60,"The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale",[27,487,488,489],"Reliability and Validity","Intensive Care Units (ICUs)","Assessment Scale",[27,487,491,489],"Intensive Care Units","2025-03-26",{"date":494,"type":40},"2025-04-03",{"date":496,"type":21},"2025-03-30",{"date":288,"type":21},{"name":499,"class":47},"Harran University",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":48},"100579717","telemedicine-wounds-100579717","NCT06827925","Telemedicine Wounds","Exploring the Effectiveness of Flipped Education in Distance Digital Learning for Long-term Care Nurses on Pressure Injury Staging Interpretation","Staging","Inclusion Criteria:\n\n* Home care worker\n* Those who have access to a smartphone and the Internet\n* After the purpose of the study was explained, they agreed to participate in the study and signed the consent form.\n\nExclusion Criteria:\n\n* Business managers or administrative managers who do not actually provide frontline care at the patient's home.",{"count":509,"type":21},112,[24],"This study aims to explore the effectiveness of the flipped education model applied to distance digital learning in enhancing the pressure injury staging interpretation skills of long-term care nursing staff. A quasi-experimental design was employed, dividing participants into a flipped education group and a conventional digital learning group. Pre- and post-intervention assessments were conducted to evaluate knowledge and skills, and differences in satisfaction and cognitive load were compared.",[27],[514,515,516,285,517],"Long-term care","nurse","Telemedicine","staging Interpretation","2025-02-10",{"date":520,"type":40},"2025-02-14",{"date":522,"type":21},"2025-04-01",{"date":326,"type":21},{"name":525,"class":47},"Asia University",{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":4},"100575315","development-of-a-nursing-care-bundle-to-prevent-pressure-injuries-and-its-impact-on-rates-and-costs-100575315","NCT06770686","Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs","Development of Nursing Care Bundle for the Prevention of Pressure Injuries, the Impact on the Rate and Cost of Pressure Injuries","Inclusion Criteria:\n\n* Being 18 years of age or older\n* Patients who fall into all risk categories assessed by the Braden scale\n* Not having developed a pressure injury anywhere on their body\n* Expectation of a minimum of 24 hours or more in the intensive care unit\n\nExclusion Criteria:\n\n* Being 18 years of age or younger\n* Having and developing a pressure injury anywhere on their body\n* Expectation of a less than 24-hour stay in the intensive care unit","65 Years",{"count":20,"type":21},[24],"Pressure injuries (PIs) represent a significant clinical complication for patients worldwide and pose financial and quality challenges for healthcare systems. These wounds, which are highly challenging to treat and care for both patients and caregivers, lead to physical and psychological trauma, negatively affect daily life activities, reduce quality of life, and increase care costs (Padula et al., 2019; Yilmazer \\& Tüzer, 2022). Moreover, the expenses associated with treatment are 2.5 times higher than those for prevention (Lyder \\& Ayello, 2007). Additionally, they often prolong hospital stays and increase the time nurses spend on care (Yilmazer \\& Tüzer, 2022).\n\nAccording to the National Pressure Injury Advisory Panel (NPIAP, 2019), providing high-quality care for patients with PIs requires adopting a multidisciplinary, standardized care approach tailored to the specific needs of patients (Heasler, 2019). Past and current literature supports the use of evidence-based care bundles to reduce PIs (Coyer et al., 2015; Chaboyer et al., 2015; Amr et al., 2017; Deakin et al., 2020; Yilmazer \\& Tüzer, 2022; Wang et al., 2023). A care bundle is a critical element for standardizing and enhancing the quality of nursing care through the utilization of evidence-based clinical practice guidelines by healthcare professionals. Therefore, adopting these evidence-based approaches will improve the consistency and quality of nursing care, enhance patient outcomes, and reduce institutional costs. Moreover, the use of care bundles during interventions promotes teamwork and collaboration while supporting the development of a common language (Anderson et al., 2015; Institute for Healthcare Improvement, 2021).\n\nThis study aims to reduce PIs, enhance the quality of patient care, lower healthcare costs, and improve overall patient outcomes through the development and implementation of a nursing care bundle based on evidence in the literature. The widespread use of the care bundle, grounded in achieved outcomes, will contribute to the prevention of PIs. Additionally, it will serve as a supportive tool for nurses to improve the quality of care.",[27,538],"Hospital Acquired Pressure Ulcer",[540,541],"Care Bundles","Cost","2025-01-07",{"date":544,"type":40},"2025-01-13",{"date":546,"type":21},"2025-01-01",{"date":522,"type":21},{"name":549,"class":47},"Koç University",{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":567,"leadSponsor":569,"locationsCount":4},"100559415","prevent-medical-device-related-pressure-injury-100559415","NCT06563830","Prevent Medical Device-Related Pressure Injury","Evaluation of the Training Applied to Nurses Prevent Medical Device-Related Pressure Injury","Although the web-based training to be given within the scope of the study is applied to nurses, the results will be evaluated on both nurses and patient care results. For this reason, both nurses and intensive care inpatients constitute the sample group.\n\nInclusion Criteria:\n\nCriteria for inclusion of nurses:\n\n-Volunteer\n\nCriteria for inclusion of patients:\n\n* Volunteer\n* Who has been hospitalized in intensive care for at least 24 hours\n* Do not have a pressure injury during admission to intensive care\n\nExclusion Criteria:\n\nExclusion criteria for nurses:\n\n-Do not volunteer\n\nCriteria for inclusion of patients:\n\n* Do not volunteer\n* Was admitted to intensive care in less than 24 hours and transferred\n* Patients with pressure injuries during admission to intensive care",{"count":558,"type":21},35,[24],"Medical Device-Related Pressure Injury (MDRPI) is a localized skin and\u002For subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Medical device-related pressure injuries are an important adverse event with a high incidence and prevalence both in our country and in the world, accounting for more than 30% of hospital-related injuries. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the most important task in preventing medical device-related pressure injuries falls on nurses, it is quite noticeable that nurses' knowledge levels of MDRPI are low in the studies conducted. MDRPI is an important issue that is ignored in nursing education and work areas in our country. In order to prevent pressure injuries associated with medical devices, it is necessary to invest more in early detection of MDRPI and improving the quality of care, studies including MDRPI risk assessment and reporting strategies are needed. In the project to be carried out in this context, it is aimed to evaluate the impact of training applied to nurses to prevent MDRPI.",[562,27],"Medical Device Site Injury","2024-10-12",{"date":565,"type":40},"2024-10-16",{"date":292,"type":21},{"date":568,"type":21},"2026-12-30",{"name":570,"class":47},"Tepecik Training and Research Hospital",{"id":572,"slug":573,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":48},"100483715","comparing-aloe-vera-gel-and-rosemary-oil-in-pressure-injury-prevention-100483715","NCT05578638","Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention","A Randomized Prospective Clinical Study on the Effect of Aloe Vera Gel and Rosmery Oil for Skin Ulcer Protection in Orthopedic Wards","Inclusion Criteria:\n\n* willingness to participate in research, lack of skin diseases (such as psoriasis, fungal illness, freckles), patients that are at risk of moderate to severe bedsores according to nursing diagnosis and Braden scoring tool and scored less than 13-14; the absence of PI on admission; the probability of length of stay should be above 10 days\n\nExclusion Criteria:\n\n* a decrease in hemoglobin levels during the study to lower than 12 in men and less than 10 mg\u002Fdl in women, anemia, hyperthermia during the study and sensitivity to Aloe Vera or Rosemary.",{"count":579,"type":21},128,[24],"Most patients admitted to the orthopedic ward are at risk of developing pressure ulcers. Today, the tendency to use medicinal herbs in pressure ulcer treatment has increased due to the variety of effective compounds and their fewer side effects.",[27],"2024-09-18",{"date":585,"type":40},"2024-09-20",{"date":587,"type":40},"2022-11-01",{"date":589,"type":21},"2024-12",{"name":591,"class":47},"Mansoura University",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":57,"sex":17,"minAge":599,"maxAge":533,"enrollmentInfo":600,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":4},"100556639","digital-multimedia-in-clinical-nurse-education-for-pressure-injury-prevention-via-line-100556639","NCT06527716","Digital Multimedia in Clinical Nurse Education for Pressure Injury Prevention Via LINE@","Exploring the Effectiveness of Applying Digital Multimedia Materials Combined With Practical Courses in Educating Clinical Nurses on Prevention of Pressure Injuries","Inclusion Criteria:\n\n1. Full-time or part-time nursing staff registered at the research site and engaged in front-line clinical care or nursing-related administrative business.\n2. Those who agreed to participate in the study and provided informed consent.\n\nExclusion Criteria:\n\nNursing internship students.","20 Years",{"count":601,"type":21},118,[24],"The goal of this clinical trial is to integrate past indicators affecting the effectiveness of pressure injury care education among nurses and to explore the learning outcomes of nurses through different educational interventions. The main questions it aims to answer are:\n\nWhat are the outcomes of nurses' knowledge, attitudes, and self-efficacy in preventing pressure injuries after receiving education through traditional media? What are the outcomes of nurses' knowledge, attitudes, and self-efficacy in preventing pressure injuries after receiving education through digital multimedia combined with practical courses? What is the satisfaction level of nurses with pressure injury prevention education after receiving education through traditional media or digital multimedia combined with practical courses?",[27],[27,606,607,608,609],"Nurse","Knowledge,","Attitude","Self-Efficacy","2024-07-25",{"date":612,"type":40},"2024-07-30",{"date":614,"type":21},"2024-10-01",{"date":616,"type":21},"2025-07-31",{"name":525,"class":47},{"id":619,"slug":620,"hasResults":11,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":57,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":637,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":48},"100556240","sumamos-excelencia-project-implementation-of-best-practices-in-clinical-practice-thrid-edition-100556240","NCT06522529","Sumamos Excelencia Project: Implementation of Best Practices in Clinical Practice (Thrid Edition)","SUMAMOS EXCELENCIA Project: Assessment of Implementation of Best Practices in a National Health System (Thrid Edition)","SE24","Inclusion Criteria:\n\n1. Unit inclusion criteria:\n\n   * NHS units and nursing homes which voluntary adhere to the project.\n   * NHS units and nursing homes providing direct patient care and commit to implement evidence-based recommendations on hand hygiene and one of the following topics: pain assessment and management, urinary incontinence management, obesity prevention and breastfeeding promotion, Smoking Cessation, falls prevention, pressure injuries prevention. For the purposes of this study, a \"unit\" is defined as any service, centre or institution that delivers health services to a homogeneous group of patients who share similar characteristics.\n2. Patient inclusion criteria: The study will include all patients attended in the units participating in the study, who meet the following criteria, depending on the recommendations to be implemented in each unit:\n\n   1. Pain:\n\n      * People susceptible to suffering some type of pain regardless of age.\n      * Patients treated in acute or chronic health institutions (Hospitals, Nursing Homes or Primary Care).\n   2. Urinary incontinence:\n\n      \\- Patients 18 years or older.\n\n      \\- Patients with uncomplicated stress, urge or mixed urinary incontinence\n\n      \\- At least 7 days of admission or possibility of continuity of care preferably up to 6 weeks.\n   3. Obesity:\n\n      * Babies and preschool children up to 12 years old.\n      * For ages 2 to 12 years (inclusive), children must not be overweight or obese 1 year prior to baseline measurement (in February 2021 or at the closest review to February 2021 at which BMI is recorded).\n      * Good general health.\n   4. Breastfeeding:\n\n      * Lactating people.\n      * Healthy neonates of gestational age greater than 36 weeks, with birth weight greater than or equal to 2500 gr.\n      * Couples and relatives within the support network.\n      * Postpartum period and up to 6 months of life of the baby (183 days of life, included).\n      * In primary care, only non-urgent care will be included.\n   5. Smoking Cessation:\n\n      \\- ≥ 18 years of age\n      * Smokers\n   6. Pressure injury prevention:\n\n      \\- Adults population (≥ 18 years).\n      * Admitted to hospitals, nursing homes or included in home care programmes.\n      * Patients at risk of developing pressure injuries.\n   7. Falls prevention:\n\n      * Adults aged 65 years or older, and adults aged 18 years or older who may potentially present problems in walking as a result of neurological or traumatic diseases, medication, or who suffer from loss of strength or drowsiness.\n   8. Hand hygiene:\n\n      \\- All health professionals who care for patients in the units participating in the study.\n\n      Exclusion Criteria:\n\n      \\-",{"count":627,"type":21},400,[24],"There is a gap between research and clinical practice, leading to variability in decision-making. Multifaceted implementation strategies are for improving implementation of best practices. Quasi-experimental, multicentre, before and after. Primary care, hospital units and nursing homes, and the patients attended at both. Implementation of evidence-based recommendations by application of a multifaceted implementation strategy (training, audit, context analysis, local strategies design, feedback, facilitation). Data will be collected at baseline and, during the first year of follow up, at months (4,8,12)",[631,632,633,634,635,27,636],"Pain","Obesity, Childhood","Breast Feeding","Incontinence, Urinary","Smoking Cessation","Fall",[638,639,640,255,641],"Implementation","Implementation science","Evidence-based practice","Quality of Health Care","2024-07-24",{"date":644,"type":40},"2024-07-26",{"date":646,"type":21},"2024-09-01",{"date":648,"type":21},"2026-01-30",{"name":650,"class":329},"Instituto de Salud Carlos III",{"id":652,"slug":653,"hasResults":11,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":659,"enrollmentInfo":660,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":669,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":4},"100544500","ideal-skiin-cares-bundle-to-prevent-pressure-injury-100544500","NCT06369688","IDEAL SKIIN CARES Bundle to Prevent Pressure Injury","Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial","IdealSkinCares","Inclusion Criteria:\n\n* be adults aged 18 years or older;\n* have been hospitalized for a minimum of 48 hours;\n* be willing to participate.\n\nExclusion Criteria:\n\n* patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;\n* have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);\n* be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);\n* individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;\n* patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;\n* admitted to the hospital for \\>28 days;\n* those with prior experience of PIs or training in PIs care and prevention.","90 Years",{"count":661,"type":21},1620,[24],"The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.",[189,27,665,666,667,668,346],"Bed Sore","Pressure Sore","Decubitus Sore","Decubitus Ulcer",[27,670,671,672,673],"Care Bundle","Hospital-acquired pressure injury","Randomized Clinical Trial","IDEAL SKIIN CARES","2024-04-15",{"date":676,"type":40},"2024-04-17",{"date":678,"type":21},"2025-10-01",{"date":680,"type":21},"2027-10-01",{"name":682,"class":47},"Baqiyatallah Medical Sciences University"]