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Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast

NCT07140198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-14

No results posted yet for this study

Summary

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

  • Breast Reconstruction
  • Lipofilling
  • Hyperbaric Oxygen Therapy

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy

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.

OTHER

Control

Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Daniel F Kalbermatten, MD, PhD · Geneva University Hospitals, Plastic surgery division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140198 on ClinicalTrials.gov