An interventional study of Hyperbaric Oxygen Therapy and Control in Breast Reconstruction, Lipofilling and Hyperbaric Oxygen Therapy, sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
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.
This is a prospective, monocentric, randomized controlled phase II crossover clinical trial designed to evaluate the efficacy and safety of hyperbaric oxygen therapy (HBOT) in improving fat graft retention following autologous fat transfer (AFT) in breast reconstruction for patients with prior radiotherapy.
AFT is widely used in breast reconstruction but is often less effective in irradiated tissues due to reduced vascularization and oxygenation, which compromises graft survival. HBOT, which involves breathing 100% oxygen at 2.5 atmospheres absolute (ATA), has been shown to promote angiogenesis and tissue oxygenation, potentially improving fat graft integration and reducing complications in irradiated tissues.
The study will enroll 16 adult female patients who have undergone radiotherapy as part of their breast cancer treatment and are scheduled to receive two sessions of AFT. Each participant will be randomized to one of two sequences:
Primary Objective:
To determine whether HBOT significantly improves fat graft retention in irradiated breast tissue, assessed as the percentage of volume retained (measured by MRI) six months postoperatively.
Secondary Objectives:
The anticipated duration of participation per subject is approximately 12 to 18 months, and the total study duration is estimated at 3 years (from November 2025 to November 2028).
University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to HBOT :
Contra-indication to MRI :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AFT alone (control) followed by AFT + HBOT (intervention)
Procedure: Hyperbaric Oxygen Therapy · Other: Control
AFT + HBOT followed by AFT alone
Procedure: Hyperbaric Oxygen Therapy · Other: Control
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.
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.
Percentage of fat graft volume retained
Fat graft volume retention in % is assessed by comparing preoperative and six-month postoperative MRI measurements.
Time frame: From enrollment until six months after the second lipofilling procedure.
Absolute retention of fat graft volume
Six months after each lipofilling procedure, an MRI is performed to evaluate the absolute retention of fat graft volume (in mL) by comparing preoperative and postoperative MRI scans.
Time frame: Participants will be followed from enrollment to six months after the second lipofilling procedure.
Clinical and radiological complications of lipofilling
During follow-up, after each intervention, patients will be assessed for postoperative complications, including infections, hematoma, implant explantation (if applicable), and reoperation. Radiological complications will also be recorded during each MRI, such as the presence of liponecrosis or oil cysts.
Time frame: Outcomes will be assessed from the time of the first lipofilling procedure through six months following the second procedure.
Number of Participants with hyperbaric oxygen therapy Related Adverse Events.
All adverse events related to hyperbaric oxygen therapy will be recorded to assess its safety in the context of the study. Premature cessation of hyperbaric oxygen therapy, along with the reasons for discontinuation, will be recorded to assess its tolerability.
Time frame: Adverse events will be monitored from the initiation of hyperbaric oxygen therapy until six months after the end of the therapy
Plan to share: No — In order to protect patient's privacy and data.
Started Mar 2026 (actual). Primary completion is estimated for Nov 2028, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.