[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fracture-related-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fracture-related-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100634090","phase-2-hyperbaric-oxygen-therapy-as-adjunctive-treatment-for-fracture-related-infection-100634090",false,"NCT07535164","Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection","Supplementary Oxygen Therapy After Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a Pilot, Non-blinded, Randomized Controlled Trial","SOLDIER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted\n\nExclusion Criteria:\n\n* Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 \\> 6.4 kPa\n* Patients with an early (i.e. diagnosed \\\u003C6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction\n* Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time)\n* Inability to understand Dutch or English","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A fracture-related infection (FRI) is a difficult to treat condition in which a bone fracture and surrounding tissues are infected. This results in impaired healing and ongoing symptoms such as pain, wound leakage and swelling, which affects patients' functioning and quality of life. Despite adequate treatment in the form of extensive surgical debridement and long-term antibiotics, it is hard to obtain infection eradication.\n\nThis pilot, non-blinded, randomized controlled trial (RCT) will assess the feasibility of a subsequent, larger RCT, in which hyperbaric oxygen therapy (HBOT) will be investigated as potential treatment modality for FRI in adjunction to standard care. HBOT induces an increased oxygen tension in the body and thereby inhibits inflammation and the growth of several bacteria. Furthermore, it stimulates bone and blood vessel formation. Therefore, HBOT might be of added value in the treatment of FRI. Data on process-related outcomes, patient-reported outcome measures, and clinical parameters are obtained during this pilot study to determine whether a subsequent study investigating the efficacy of HBOT is viable.",[27,28],"Fracture Related Infection","Hyperbaric Oxygenation",[30,31,32,33,34],"Hyperbaric oxygen therapy","Fracture-related infection","Lower extremity","Feasibility studies","Randomized controlled trial","NOT_YET_RECRUITING","2026-04-09",{"date":38,"type":39},"2026-04-16","ACTUAL",{"date":41,"type":21},"2026-08",{"date":43,"type":21},"2028-08",{"name":45,"class":46},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100516891","cerament-g-device-registry-100516891","NCT06010433","CERAMENT G Device Registry","Inclusion Criteria:\n\n* 18 years and over (on the day of surgery)\n* receive CERAMENT\\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product\n* In receipt of patient information leaflet and have signed appropriately designed informed consent form.\n\nExclusion Criteria:\n\n* Any exclusion criteria as per IFU for CERAMENT\\|G\n* Any off-label use",{"count":55,"type":21},100,"12 Months","OBSERVATIONAL","This is an Observational Device Registry Study of CERAMENT\\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.",[60,27,61],"Chronic Osteomyelitis","Diabetic Foot Osteomyelitis","RECRUITING","2025-09-23",{"date":65,"type":39},"2025-09-26",{"date":67,"type":39},"2023-08-17",{"date":69,"type":21},"2028-09-22",{"name":71,"class":72},"BONESUPPORT AB","INDUSTRY",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100530941","external-fixator-or-antibiotic-coated-plate-in-severe-open-long-bone-fractures-100530941","NCT06193330","External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures","Use of Antibiotics-cement Coated Plate in the Treatment of Gustilo-Anderson Type III Long Bone Fractures in Low- and Middle-income Countries vs External Fixation: A Multi-centre Randomized Control Trial","Inclusion Criteria:\n\n* Age ≥ 18yrs,\n* Gustilo-Anderson IIIA and IIIB open fractures,\n* involvement of any long bone fractures that can be fixed with either plate or uniplanar external fixation,\n* wound can be closed primarily, with skin graft or flap, or can heal secondarily\n\nExclusion Criteria:\n\n* Patients with traumatic brain injury,\n* spinal cord injury,\n* severe burns,\n\n  * 1 long bone fractures,\n* refusal to consent,\n* history of allergies to ceftriaxone or sulbactam,\n* fractures associated with vascular injury\n* and non-compliance with follow-up.",{"count":81,"type":21},178,[83],"NA","The purpose of the study is to assess whether infection rate is reduced with use of antibiotic-coated plate in severe open tibial fractures compare to use of external fixators",[27],"2023-12-21",{"date":88,"type":39},"2024-01-05",{"date":90,"type":21},"2024-01-01",{"date":92,"type":21},"2026-12-31",{"name":94,"class":46},"Oluwasegun Aremu",2]