Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Geneva
About this trial
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 criteria
Qualifiers
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.
Ability to provide informed consent, documented by signature
Disqualifiers
Pregnancy or breastfeeding
Unability to provide informed consent
Previous enrolment into the current investigation
Anamnestically reported spontaneous pneumothorax
Trial design
Treatments tested in this trial
- Hyperbaric Oxygen Therapy
- Control
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov