[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634090":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperbaric oxygen therapy (HBOT) + standard care","EXPERIMENTAL","Subjects receive 20 HBOT sessions within 30 days in addition to standard care. The first HBOT session will be conducted within 7 days after the index surgery in the context of FRI treatment.",[13],"Drug: Hyperbaric Oxygen Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Subjects receive standard care, consisting of at least surgical debridement of the FRI and administration of antibiotics.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Hyperbaric Oxygen Therapy","Each HBOT session will be conducted in accordance with the following protocol: three 20 minute blocks and one 15 minute block of 100% oxygen breathing at 2.4 ATA, split up by 5 minutes of oxygen rest (i.e. breathing air with 21% oxygen at 2.4 ATA)",[9],[26],{"name":27,"affiliation":28,"role":29},"Markus W Hollmann, MD PhD PhD Professor","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Robert P Weenink, MD PhD","CONTACT","+31205669111","r.p.weenink@amsterdamumc.nl",[37],{"facility":28,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Amsterdam","North Holland","1105AZ","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.88969,52.37403,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":18,"phoneExt":18,"email":52},"Silke D de Wolde, MD","s.d.dewolde@amsterdamumc.nl",{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Professor Markus W Hollmann","MD PhD PhD Professor",[57],{"name":58,"class":59},"Stichting ZiektekostenVerzekering Krijgsmacht","UNKNOWN","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":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79],"Fracture Related Infection","Hyperbaric Oxygenation",[81,82,83,84,85],"Hyperbaric oxygen therapy","Fracture-related infection","Lower extremity","Feasibility studies","Randomized controlled trial","NOT_YET_RECRUITING","2026-04-09",{"date":89,"type":90},"2026-04-16","ACTUAL",{"date":92,"type":72},"2026-08",{"date":94,"type":72},"2028-08",{"name":5,"class":6},1]