[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surgical-wound-dehiscence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surgical-wound-dehiscence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,87,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":45,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679",false,"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)","ALL",{"count":19,"type":20},300000,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Diabetic Foot","Pressure Ulcer","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Leg Ulcer","Pyoderma","Peripheral Arterial Disease","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Pressure Ulcer (PU)","Diabetic Foot Ulcers (DFUs)","Pressure Injury","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[46,47,48,49,50,51,52,53,26,40,54,55,34,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"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","RECRUITING","2025-07-10",{"date":77,"type":78},"2025-07-16","ACTUAL",{"date":80,"type":78},"2005-01-01",{"date":82,"type":20},"2030-01",{"name":84,"class":85},"U.S. Wound Registry","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":107,"locationsCount":86},"100572188","dermacyte-liquid-for-treatment-of-cutaneous-ulcers-and-wounds-100572188","NCT06730022","Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds","Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator\n\nExclusion Criteria:\n\n* Must not be pregnant or lactating\n* Must not have known malignancies\n* Must not be less than 18 years of age","18 Years","EXPANDED_ACCESS","The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.",[97,98,27,99,100,101,102],"Cutaneous Ulcer","Diabetic Ulcer","Burns - Multiple","Pressure Ulcers","Mixed Ulcer","Ischemic Ulcer","AVAILABLE","2025-02-21",{"date":106,"type":78},"2025-02-25",{"name":108,"class":109},"Merakris Therapeutics","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":86},"100433140","real-world-evidence-with-the-debritom-tm-novel-micro-water-jet-technology-at-a-single-wound-center-100433140","NCT04920253","Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center","EVIDENT","Inclusion Criteria:\n\nGeneral\n\nPotential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:\n\n1. At least 18 years old.\n2. The index wound (i.e. current episode of the wound or ulceration) has been present for greater than 4 weeks prior to SV 1 and has had less than 1 year of documented medical treatment, as of the subject's consent for the study participation.\n3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1.\n4. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.\n5. Subject must have read and signed the IRB approved Informed Consent Form (ICF) before study specific screening procedures that are not standard of care are undertaken.\n\n   DFU\n6. Presence of diabetic foot ulcer (DFU) that meets all of the following features:\n7. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to the ligament, tendon, joint capsule or fascia\n8. Without abscess or osteomyelitis\n9. The index ulcer will be the largest ulcer if two or more DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2cm distant from index ulcer (edge to edge).\n10. The index ulcer has been offloaded for at least 14 days prior to randomization\n11. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave forms present must have adequate micro circulation as evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of an ABI test performed using the index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study. Otherwise, this must be completed in the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or documented adequate microcirculation as determined by a Clarifi SFDI Vascular Assessment Tool.\n\n    VLU\n12. All wounds using the CEAP VLU Classification, except for those in the exclusion criteria. (See Appendix A for definitions)\n13. The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other Ulcerations are present on the same leg, they must be more than 2cm distant from index ulcer.\n14. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave forms present must have adequate micro circulation as evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of an ABI test performed using the index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study. Otherwise, this must be completed in the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or documented adequate microcirculation as determined by a Clarifi SFDI Vascular Assessment Tool.\n\n    Surgical Dehisced\n15. All wounds using the Sandy Grading System, except those in the exclusion criteria. (See Appendix A for definitions)\n\n    Traumatic\n16. All wounds as per the CDC Surgical Wound Classification, with the exception of Class IV or dirty infected wounds, SSI - Deep incisional and organ space. (See Appendix A for definitions)\n\nExclusion Criteria:\n\nGeneral\n\nPotential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization:\n\n1. The index wound, in the opinion of the investigator, is suspicious for cancer or have a positive carcinoma diagnosis.\n2. Subject has a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within 1 month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.\n3. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.\n4. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.\n5. History of radiation at the wound site (regardless of time since last radiation treatment).\n6. Index wound has been previously treated or will need to be treated with any prohibited therapies (See Section 6 of this protocol for a list of prohibited medications and therapies).\n7. Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.\n8. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or the subject has a known history of poor adherence with medical treatment.\n9. Subject is pregnant or breast-feeding.\n10. Presence of diabetes with poor metabolic control as documented with an HbA1c \\>12.0 % within 90 days of randomization.\n11. Subject has end-stage renal disease as evidenced by a serum creatinine \\> 3.0mg\u002FdL within 6 months of randomization.\n12. BMI \\>55\n13. PAR experiences a \\>30% change between SV1 and SV2 DFU\n14. Wagner 2 wounds that require debridement of bone.\n15. Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n    VLU\n16. Exclude\n\n    1. Secondary post thrombotic\n    2. Venous Obstruction\n    3. Venous Obstruction with reflux\n    4. Lipodermato sclerosis or atrophic blanche\n17. Osteomyelitis or bone infection of the affected leg as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n    Surgical Dehisced\n18. Using the Sandy Grading System for Surgical Wound Dehiscence: Wounds Grade 3 where organs are exposed, and 3a, where the infection is severe as deemed by the Principal Investigator.\n\n    Traumatic\n19. Using CDC Surgical Wound Classification, exclude\n\n    1. Class IV - dirty infected wounds\n    2. SSI - Deep incisional and organ space",{"count":118,"type":20},180,"INTERVENTIONAL",[121],"NA","Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.",[52,53,27,43],"2024-11-19",{"date":126,"type":78},"2024-11-21",{"date":128,"type":78},"2021-11-29",{"date":130,"type":20},"2025-12",{"name":132,"class":109},"Medaxis, LLC"]