Spots Global Cancer Trial Database for Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

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Trial Identification

Brief Title: Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

Official Title: 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

Study ID: NCT02263651

Conditions

Breast Cancer

Interventions

Quilting suture without drainage

Conventional closure with drainage

Study Description

Brief Summary: 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.

Detailed Description: 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.