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Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Sponsor: University Hospital, Geneva
Summary
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: Does 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. Sixteen 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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-11
Completion Date
2028-12
Last Updated
2025-08-24
Healthy Volunteers
No
Interventions
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.
Control
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.