Actively Recruiting
Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Led by University Hospital, Geneva · Updated on 2026-05-14
16
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients aged 18 years or older
- Candidates for lipofilling after breast reconstruction following radiation therapy
- Ability to provide informed consent documented by signature
You will not qualify if you...
- Pregnancy or breastfeeding
- Unable to provide informed consent
- Previous enrollment in this trial
- History of spontaneous pneumothorax
- Prior thoracotomy
- Significant lung lesions including emphysematous bullae
- Respiratory function disorders
- Major psychiatric disorders
- Uncontrollable claustrophobia
- Seizures or severe traumatic brain injury with neurological deficits
- Decompensated heart failure
- Recent myocardial infarction under 6 months or with lasting hemodynamic effects
- Spastic coronary angina
- Cardiac arrhythmias or conduction disorders
- Implanted pacemakers with unknown pressure resistance
- Severe bradycardia
- Sinus ostium displacement
- Auditory canal entrance displacement
- Recent tympanoplasty under 3 months
- Acute febrile illness
- Optic neuritis
- Unstable hyperthyroidism
- Contraindications to MRI including non-compatible implants or metallic foreign bodies in critical areas
AI-Screening
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Trial Site Locations
Total: 1 location
1
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland, 1206
Actively Recruiting
Research Team
D
Dominik André-Lévigne, MD, PhD
CONTACT
M
Matteo Scampa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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