Breast Cancer Clinical Trial
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
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.
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