Effect of Hyperbaric Oxygen Therapy on the Survival of Fat Graft in Post-Radiation Setting.
Descrizione riassuntiva dello studio
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)
Intervento studiato
Use of hyperbaric oxygen therapy to promote the survival of fat grafts (lipofilling) in irradiated tissue.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
- Vulnerable patient groups (minors, major disability, pregnancy) - Contraindication to hyperbaric oxygen therapy or to the performance of an MRI. (BASEC)
Luogo dello studio
Ginevra
(BASEC)
Sponsor
Prof. Daniel F. Kalbermatten, Service de chirurgie plastique, reconstructive et esthétique, Hôpitaux Universitaires de Genève
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Matteo Scampa
+41 79 553 85 42
matteo.scampa@clutterhug.chService de chirurgie plastique, reconstructive et esthétique, Hôpitaux Universitaires de Genève
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
01.10.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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