BACKGROUND:Closed-suction drainage to reduce seromas is standard after mastectomy. This study evaluates the safety of early drain removal. METHODS:Women undergoing mastectomy were randomized to early removal on postoperative day 2 or standard removal (< 30 mL drainage in 24 hours or postoperative day 14). Primary endpoints were time to drain removal and physician visits. Secondary endpoints were number of seroma aspirations, drain reinsertions, and infections. RESULTS:Twenty-seven patients were recruited before an interim analysis was performed to address safety concerns. Three patients withdrew before trial completion, leaving 14 patients in the standard group and 10 in the early group. Patients in the standard group had significantly fewer seroma aspirations, fewer drain reinsertions, and fewer physician visits. The trial was halted because of the higher rate of events in the early group. CONCLUSION: Surgical drains cannot be safely removed on postoperative day 2 after mastectomy. Early removal significantly increases the occurrence of seromas requiring treatment.
RCT Entities:
BACKGROUND: Closed-suction drainage to reduce seromas is standard after mastectomy. This study evaluates the safety of early drain removal. METHODS:Women undergoing mastectomy were randomized to early removal on postoperative day 2 or standard removal (< 30 mL drainage in 24 hours or postoperative day 14). Primary endpoints were time to drain removal and physician visits. Secondary endpoints were number of seroma aspirations, drain reinsertions, and infections. RESULTS: Twenty-seven patients were recruited before an interim analysis was performed to address safety concerns. Three patients withdrew before trial completion, leaving 14 patients in the standard group and 10 in the early group. Patients in the standard group had significantly fewer seroma aspirations, fewer drain reinsertions, and fewer physician visits. The trial was halted because of the higher rate of events in the early group. CONCLUSION: Surgical drains cannot be safely removed on postoperative day 2 after mastectomy. Early removal significantly increases the occurrence of seromas requiring treatment.
Authors: Jennifer L Milucky; Allison M Deal; Carey Anders; Rebecca Wu; Richard Sean McNally; Clara N Lee Journal: Clin Breast Cancer Date: 2016-08-08 Impact factor: 3.225