RecruitingNot ApplicableNCT07140198

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


Sponsor

University Hospital, Geneva

Enrollment

16 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control and a procedure called Hyperbaric Oxygen Therapy for people with breast reconstruction, hyperbaric oxygen therapy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHyperbaric 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.

OTHERControl

Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.


Locations(1)

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

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NCT07140198


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