[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteomyelitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteomyelitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,77,99,127,154,176,213,266],{"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":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100613729","antibiotic-device-for-osteomyelitis-of-the-extremities-pivotal-trial---genex-with-gentamicin-100613729",false,"NCT07270380","Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.","A Multi-center, Single-arm, Historically Controlled Pivotal Trial, to Assess the Safety and Effectiveness of Genex G as Part of the Surgical Treatment of Osteomyelitis of the Extremities.","ADOPT GG","Inclusion Criteria:\n\n1. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery\n2. Patients at least 18 years of age \\*1\n3. Patient willing and able to provide written informed consent\n4. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator\n5. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)\n\n   * 1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated.\n\nExclusion Criteria:\n\n1. Patients diagnosed with acute osteomyelitis\n2. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery\n3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg\u002FdL (309umol\u002FL) or being treated with dialysis\n4. Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team\n5. Uncontrolled diabetes mellitus (hemoglobin A1c levels \\>10%)\n6. Pre-existing calcium metabolism disorder\n7. Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery)\n8. History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)\n9. Participation in an investigational drug\u002Fdevice study (within the last 60 days) or prior enrolment to the ADOPT GG study\n10. Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life)\n11. Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy\n12. Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria\n13. Current user of any products containing nicotine\n14. Currently incarcerated","ALL","18 Years",{"count":20,"type":21},139,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.",[27],"Osteomyelitis",[29,30,31,32,33,34,35],"Single Arm","Historical Control","Pivotal Device Study","Bone Void Filler","Gentamicin","Systemic Antibiotics","genex","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":21},"2026-06",{"date":44,"type":21},"2028-10",{"name":46,"class":47},"Biocomposites Ltd","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100537911","phase-2-a-randomized-controlled-phase-ii-trial-of-stimulan-vg-vs-standard-of-care-soc-for-the-treatment-of-osteomyelitis-associated-with-stage-iv-pressure-ulcers-100537911","NCT06283979","A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","BLADE OPU2","In order to be eligible to participate in this study, subjects must meet all of the following criteria:\n\n1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage\u002Fprimary closure.\n2. Operative candidate for flap surgery or primary closure.\n3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.\n4. Adults ≥ 18 years in age at the time of treatment.\n5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.\n6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.\n\nSubjects who meet any of the following criteria will be excluded from participating in this study:\n\n1. Reasons contributing to pressure ulcer cannot be addressed.\n2. Severe immunological compromised patients as determined by the clinician.\n3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.\n4. Patients presenting with head pressure ulcers.\n5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety\u002Frecovery or ability to follow the trial procedures.\n6. Current smoker.\n7. Diabetic patient with Hba1C level above 9.\n8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).\n9. Concurrent involvement in a study of another investigational product.\n10. Pregnant or planning to become pregnant during study period.\n11. Flexion contractures where patient cannot passively get full extension.\n12. Uncontrolled muscle spasms.\n13. Unable to comply with bedrest restriction or offloading requirements\n14. Unable to provide consent.\n15. Fecal or urinary incontinence with contamination of the wound.\n16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \\*\n17. Investigator considers the participant to be clinically malnourished.\n18. Any conditions with known hypercalcemia (\\> 10.3 mg\u002Fdl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).\n19. Investigator believes trial participation may compromise safety of the participant or trial results.\n\n    * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization",{"count":58,"type":21},60,[60],"PHASE2","The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.",[63,27],"Pressure Ulcer, Stage IV",[65,66,67,68],"between-group effect size","surgical debridement","ulcer bursectomy","systemic antibiotics","2026-05-01",{"date":71,"type":40},"2026-05-06",{"date":73,"type":40},"2025-06-15",{"date":75,"type":21},"2026-12-01",{"name":46,"class":47},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100558801","cerament-g-as-part-of-the-surgical-treatment-of-osteomyelitis-in-a-single-stage-procedure-100558801","NCT06555848","CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure","A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure","CERTITUDE","Inclusion Criteria:\n\nSubjects meeting the following inclusion criteria are to be included in the analysis:\n\n1. Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.\n2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:\n\n   1. the presence of a sinus\n   2. the presence of an abscess or intra-operative pus\n   3. the presence of positive supportive histology\n   4. two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is \\\u003C 1cm after debridement and excision of bone has been performed.\n\nExclusion Criteria:\n\nThe subject will be excluded from the study if:\n\n1. Skeletal immaturity, defined as pre-operative\u002F screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)\n2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included\n3. A known allergy or reaction to gentamicin or calcium sulfate\n4. Treatment with a combination of different antibiotic-eluting bone graft substitutes\n5. They have a segmental bone defect \\> 1cm\n6. Infection of the spine",{"count":86,"type":21},128,"OBSERVATIONAL","The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.",[27],"2026-04-28",{"date":92,"type":40},"2026-05-04",{"date":94,"type":40},"2025-06-02",{"date":96,"type":21},"2032-10",{"name":98,"class":47},"BONESUPPORT AB",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100403801","phase-4-bone-and-joint-infections---simplifying-treatment-in-children-trial-100403801","NCT04538053","BonE and Joint Infections - Simplifying Treatment in Children Trial","BEST","Inclusion Criteria:\n\n* Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.\n\nExclusion Criteria:\n\n1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)\n2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)\n3. Concomitant severe, invasive infection e.g. necrosing fasciitis\n4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)\n5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins\n6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection\n7. Prior episode of OM or SA\n8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)\n9. Prior enrolment in the trial\n10. Current recipient of another investigational product as part of a clinical trial","1 Year",{"count":108,"type":21},285,[110],"PHASE4","This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.",[113,114,115,27],"Bone Infection","Septic Arthritis","Bone and Joint Infection","2025-11-14",{"date":118,"type":40},"2025-11-17",{"date":120,"type":40},"2021-06-01",{"date":122,"type":21},"2026-12",{"name":124,"class":125},"Murdoch Childrens Research Institute","OTHER",10,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":48},"100597386","the-achills-trial-application-of-cerament-in-heel-infection-for-lower-limb-salvage-100597386","NCT07057817","The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage","Randomised Controlled Trial Comparing Partial Calcanectomy Plus Local Application Antibiotic Impregnated Bone Graft Substitute for Calcaneal Osteomyelitis vs Partial Calcanectomy Alone (The ACHILLS Trial)","ACHILLS","Inclusion Criteria:\n\n* 18 and over\n* Undergoing partial calcanectomy\n* Patients with Type1 or Type 2 Diabetes\n* Patients will be stratified by Pulse status and eGFR\n\nExclusion Criteria:\n\n* Patients unfit for surgery\n* Patients unable to provide informed consent\n* Patients with overwhelming sepsis that require major amputation\n* Patients with hypersensitivity to aminoglycosides\n* Pre-existing calcium metabolism disorder\n* Severe renal impairment\n* Patients in whom major limb amputation is deemed inevitable by the treating physician",{"count":136,"type":21},30,[24],"The ACHILLS Trial is a multicentre randomised controlled feasibility study comparing partial calcanectomy with and without the use of an antibiotic-impregnated bone graft substitute (Cerament G) for treating calcaneal osteomyelitis, specifically on wound healing rates, re-infection, and overall efficacy in a sample of 30 patients over a one-year period.",[27,140,141],"Diabetes","Calcanectomy",[141,143],"Eq5d5l","NOT_YET_RECRUITING","2025-07-30",{"date":147,"type":40},"2025-08-03",{"date":149,"type":21},"2025-07-25",{"date":151,"type":21},"2026-07-25",{"name":153,"class":125},"Royal College of Surgeons, Ireland",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":48},"100597314","monotherapy-vs-combination-therapy-for-bone-infections-caused-by-pseudomonas-aeruginosa-100597314","NCT07056881","Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa","Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Diagnosis of osteitis or osteomyelitis due to Pseudomonas aeruginosa\n* Isolation of Pseudomonas aeruginosa from at least one deep, sterile sample (e.g., bone biopsy, joint aspiration)\n* Imaging findings consistent with osteomyelitis (MRI, CT scan, or X-ray)\n\nExclusion Criteria:\n\n* No isolation of Pseudomonas aeruginosa\n* No imaging evidence suggestive of osteomyelitis\n* Patients under 18 years of age",{"count":161,"type":21},300,"This study looks at how well one antibiotic (monotherapy) works compared to two antibiotics (combination therapy) in treating bone infections caused by Pseudomonas aeruginosa. It includes 300 adult patients who had this type of infection confirmed by lab tests and medical imaging. The goal is to find out if using just one antibiotic is as effective as using two, while also looking at side effects, the need for more surgery, antibiotic resistance, and overall antibiotic use.",[27,164,165,166],"Pseudomonas Infections","Pseudomonas Aeruginosa","Bacterial Infections","2025-06-30",{"date":169,"type":40},"2025-07-09",{"date":171,"type":40},"2025-04-11",{"date":173,"type":21},"2026-04-15",{"name":175,"class":125},"Centre Hospitalier de Saint-Denis",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":198,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100331368","additional-hyperbaric-oxygen-after-lower-extremity-amputation-100331368","NCT03594344","Additional Hyperbaric Oxygen After Lower Extremity Amputation","Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial","AHOLEA","Inclusion Criteria:\n\n* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.\n* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist\u002FHyperbaric Medicine Physician.\n* Able to cooperate and follow up appointments\n* Included within 7 days after final surgery\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Pregnancy\n* Dementia","90 Years",{"count":186,"type":21},120,[24],"This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.",[190,191,192,27,193,194,195,196,197],"Diabetes Mellitus","Claudication, Intermittent","Critical Limb Ischemia","Amputation","Lower Extremity Ulcer","Diabetic Angiopathy","Diabetic Neuropathies","Diabetic Foot",[199,140,200,201,202],"Diabetic foot","Lower extremity amputation","Hyperbaric oxygen therapy","HBOT","2025-03-25",{"date":205,"type":40},"2025-03-30",{"date":207,"type":40},"2018-07-04",{"date":209,"type":21},"2026-12-31",{"name":211,"class":125},"Oslo University Hospital",2,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":223,"conditions":224,"keywords":239,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234","NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection",{"count":222,"type":21},1000,"The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[166,225,27,226,227,228,229,230,231,232,233,234,235,236,237,238],"Bone Diseases, Infectious","Central Nervous System Bacterial Infections","Meningitis, Bacterial","Encephalitis","Brain Abscess","Urinary Tract Infections","Respiratory Tract Infections","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Sepsis","Bacteremia","Endocarditis, Bacterial",[240,241,242,243,244,245,246,247,248,249,166,250,251,225,27,226,227,228,229,230,231,232,233,234,235,236,237,238,252,253,254,255],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","Safety","2024-09-27",{"date":258,"type":40},"2024-10-01",{"date":260,"type":4},"2016-12",{"date":262,"type":21},"2030-12",{"name":264,"class":47},"Infectopharm Arzneimittel GmbH",50,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":275,"conditions":276,"keywords":279,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":48},"100494051","treatment-of-osteomyelitis-associated-pressure-ulcers-by-surgical-flaps-and-anti-bacterial-agents-100494051","NCT05713149","Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents","Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study","Inclusion Criteria:\n\n* Patients \\>= 18 years old ;\n* Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;\n* Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;\n* Having a neuromotor disability;\n* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;\n* Affiliation to a social security scheme.\n\nExclusion Criteria:\n\n* Under court protection.",{"count":274,"type":21},400,"People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers.\n\nThe management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples.\n\nThe aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.",[277,278,27],"Disability or Chronic Disease Leading to Disablement","Pressure Ulcer",[280],"Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture","2023-02-18",{"date":283,"type":40},"2023-02-21",{"date":285,"type":40},"2023-02-19",{"date":287,"type":21},"2027-02-01",{"name":289,"class":125},"Institut de Sante Parasport Connecte Synergies"]