Effect of Hyperbaric Oxygen Therapy on the Survival of Fat Graft in Post-Radiation Setting.
Summary description of the study
This is a study investigating the effect of hyperbaric oxygen therapy (the hyperbaric chamber) on the survival of fat transfer (lipofilling) in the context of breast reconstruction for patients who have undergone radiation therapy as part of their breast cancer treatment. This is a prospective study where patients will undergo a total of 2 consecutive lipofilling sessions. After the first session, patients will be randomly assigned to one of 2 groups (intervention or control), and then they will be assigned to the other group during the second lipofilling session (cross-over study): - In the intervention group, patients will receive 5 sessions of hyperbaric oxygen therapy. - In the control group, patients will not receive hyperbaric oxygen therapy, but will only have standard post-operative follow-up. The volume of residual fat will be evaluated through a breast MRI performed between 3 and 12 months after the intervention. A beneficial effect of hyperbaric oxygen therapy is expected on the proportion of transplanted fat surviving after the fat transfer (lipofilling) procedure. This proportion will be calculated based on a pre-operative breast MRI, the volume of fat injected, as well as the post-operative MRI. The person interpreting the radiological images (MRI) will not be informed of the group to which the patient belongs.
(BASEC)
Intervention under investigation
Use of hyperbaric oxygen therapy to promote the survival of fat grafts (lipofilling) in irradiated tissue.
(BASEC)
Disease under investigation
Breast Reconstruction in the Context of Breast Cancer
(BASEC)
- Adult female patient scheduled for surgical fat transfer in the context of breast reconstruction following breast cancer where one of the treatments was breast irradiation. - Ability to understand the study and provide written consent for participation. (BASEC)
Exclusion criteria
- Vulnerable patient groups (minors, major disability, pregnancy) - Contraindication to hyperbaric oxygen therapy or to the performance of an MRI. (BASEC)
Trial sites
Geneva
(BASEC)
Sponsor
Prof. Daniel F. Kalbermatten, Service de chirurgie plastique, reconstructive et esthétique, Hôpitaux Universitaires de Genève
(BASEC)
Contact
Contact Person Switzerland
Dr. Matteo Scampa
+41 79 553 85 42
matteo.scampa@clutterhug.chService de chirurgie plastique, reconstructive et esthétique, Hôpitaux Universitaires de Genève
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
01.10.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Étude prospective pour évaluer l'efficacité de l'oxygénothérapie hyperbare (HBOT) dans l'amélioration de la survie des transferts de graisse autologues pour la reconstruction mammaire après radiothérapie. Un essai contrôlé randomisé de phase II avec cross-over (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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