[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603721":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Sequence AB","AFT alone (control) followed by AFT + HBOT (intervention)",[12,13],"Procedure: Hyperbaric Oxygen Therapy","Other: Control",{"label":15,"type":6,"description":16,"interventionNames":17},"Sequence BA","AFT + HBOT followed by AFT alone",[12,13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Hyperbaric Oxygen Therapy","HBOT will be administered in five sessions (1 on Day 0, 2 on Day 1, 2 on Day 2), beginning immediately after the lipofilling. Each session consists of 100% oxygen inhalation at 2.5 ATA for 90 minutes. Postoperative MRI will be performed six months after each AFT session to assess the volume of retained graft.",[9,15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Control","Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.",[9,15],[30],{"name":31,"affiliation":32,"role":33},"Daniel F Kalbermatten, MD, PhD","Geneva University Hospitals, Plastic surgery division","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Dominik André-Lévigne, MD, PhD","CONTACT","+41 (0)22 372 79 97","dlev@hug.ch",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Matteo Scampa, MD","+41 (0)79 55 38 542","asmp@hug.ch",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Geneva University Hospitals","RECRUITING","Geneva","Canton of Geneva","1206","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],6.14569,46.20222,{"lat":57,"lon":56},[60,62],{"name":61,"role":37,"phone":38,"phoneExt":24,"email":39},"Dominik André-Lévigne, MD-PhD",{"name":41,"role":37,"phone":63,"phoneExt":24,"email":43},"+41 (0)79 553 85 42",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Dominik André-Lévigne","Doctor","100603721","hyperbaric-oxygen-therapy-to-improve-autologous-fat-graft-intake-in-irradiated-breast-100603721",false,"NCT07140198","Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast","Prospective Study to Evaluate the Effectiveness of Hyperbaric Oxygen Therapy (HBOT) to Increase the Survival of Autologous Fat Transfer for Breast Reconstruction After Radiotherapy: A Randomized Controlled Phase II Cross-over Trial","Inclusion Criteria:\n\n* Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation therapy on the affected breast.\n* Ability to provide informed consent, documented by signature\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Unability to provide informed consent\n* Previous enrolment into the current investigation\n\nContra-indication to HBOT :\n\n* Anamnestically reported spontaneous pneumothorax\n* Status post-thoracotomy\n* Significant intra-pulmonary lesions (including emphysematous bullae)\n* Respiratory function disorders (both obstructive and restrictive syndromes)\n* Pregnancy\n* Major psychiatric disorders\n* Uncontrollable claustrophobic reaction\n* Seizures, even if treated and asymptomatic for some time\n* Status post-severe traumatic brain injury with neurological deficits and seizures\n* Decompensated heart failure\n* Recent myocardial infarction (\\\u003C6 months) or with persistent hemodynamic sequelae\n* Spastic coronary angina\n* Cardiac arrhythmias, atrioventricular block, Wolff-Parkinson-White syndrome, sinus node dysfunction, Lown-Ganong-Levine syndrome\n* Cardiac pacemakers with unknown pressure resistance\n* Severe bradycardia\n* Sinus ostium displacement (acute or chronic)\n* Displacement of the auditory canal entrance (acute or chronic)\n* Status post-tympanoplasty type I-III \\\u003C3 months\n* Acute febrile state\n* Optic neuritis\n* Unstabilized hyperthyroidism\n\nContra-indication to MRI :\n\n* Non-MRI-compatible pacemaker, cochlear implant, drug-infusion pump or neurostimulator.\n* Metallic foreign body in critical area (eye, brain, etc.)\n* Ferromagnetic vascular surgical clips of older generation, e.g., for intracranial aneurysm repair.","FEMALE","18 Years",{"count":78,"type":79},16,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) enhances fat graft survival in lipofilling procedures in irradiated breast cancer patients. The main questions it aims to answer are:\n\nDoes it improve fat graft survival ? Evaluate safety and tolerability of HBOT in this setting? Researchers will compare patient receiving HBOT to a control group without HBOT to see if.\n\nSixteen female patients will undergo two autologous fat grafting sessions: one with HBOT and one without, in a randomized sequence. Patients will undergo three MRI during the study to evaluate the fat retention rate.",[85,86,21],"Breast Reconstruction","Lipofilling",[88,89,90,91],"breast reconstruction","Irradiation","hyperbaric oxygen therapy","lipofilling","2026-05-11",{"date":94,"type":95},"2026-05-14","ACTUAL",{"date":97,"type":95},"2026-03-01",{"date":99,"type":79},"2028-12",{"name":5,"class":6},1]