Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial

The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.

Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection

Randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).

Two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.

Inclusion Criteria:

• Women ≥ 18 years and ≤ 85 years
• Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
• Women that give her informed written consent
• French social security affiliation

Exclusion Criteria:

• Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.
• Women with indication of bilateral mastectomy or immediate reconstruction.
• Degenerative neuromuscular disease with thoracic muscular damage
• Planned ambulatory surgery