Status:
UNKNOWN
BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
INSERM Bichat hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast canc...
Detailed Description
This is a phase 2 monocentric study, following the 2 step Simon Minimax design. We will be carrying out cycles of ischemic preconditioning for 40 minutes, simulating 2 cycles of ischemia-reperfusion ...
Eligibility Criteria
Inclusion
- female with age ≥ 18
- Secondary unilateral breast reconstruction using DIEP
- Signed consent form
- Beneficiary of a social security scheme
Exclusion
- Smoking: active or quit since \< 2 months, contraindication for flap surgery
- Pregnancy: contraindication for surgery
- Immediate breast reconstruction, at the same time as the mastectomy (increases cutaneous complications and different surgical technique)
- Bilateral breast reconstruction (increases operation time and post operation complications)
- Patient under curatorship or guardianship
- Patient deprived of their liberty, and patient undergoing psychiatric care
- Risk factor for DIEP complication such as: previous surgical procedures performed on the abdomen, carcinological treatments and severe comorbidities of the patient.
- Risk factors for complications of mechanical preconditioning. Soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis,
- Participation in another interventional study
- Any contraindication to general anesthesia
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05373069
Start Date
May 1 2022
End Date
May 1 2024
Last Update
May 13 2022
Active Locations (1)
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1
Service Plastique, Reconstruction, Esthétique, Hôpital TENON- APHP
Paris, France, 75020