Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05373069
Eligibility Criteria:
Inclusion Criteria:
* female with age ≥ 18
* Secondary unilateral breast reconstruction using DIEP
* Signed consent form
* Beneficiary of a social security scheme
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05373069
Study Brief:
Protocol Section:
NCT05373069