Evaluation of Topical Sclerosant Agents for Minimization of Postmastectomy Seroma: A Placebo-Controlled, Double-Blind, Randomized Trial.

Abstract

Objective: Seroma after mastectomy is a bothersome problem. Topical sclerosants are one method used to reduce seroma. The aim of this study was to evaluate if spraying flaps before closure with doxycycline or bleomycin after total mastectomy can prevent seroma.

Materials and methods: After institutional review board approval, using a computer-based randomization program, a prospective, double-blind, placebo-controlled randomized, superiority study was conducted during the period from the first of August 2017 to the first of August 2018. IRB proposal code was MS/17.08.66 and the trial was approved at 15/8/2017. The trial is available publicly at http://www.eulc.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12553049. The primary outcome of the study was to assess the incidence of seroma following total mastectomy after intervention comprising spraying of skin flaps with doxycycline or bleomycin versus placebo. Patients who were candidates for total mastectomy were randomized into control, doxycycline, and bleomycin groups. The postoperative data included length of the hospital stay, pain score among the three groups, post-operative drained fluid volume, post-operative day of drain removal, complication rates including infection, flap necrosis and hematoma, the incidence of seroma and aspirated seroma volume, and total number of postoperative visits.

Results: Of 125 patients, 90 were candidates for total mastectomy. Analysis of these 90 showed that the incidence of seroma was similar; 43.4%, 40% and 40% in the control, doxycycline, and bleomycin groups, respectively (p = 0.99). Furthermore, wound complication rates were similar among all groups.

Conclusion: Despite improved recognition and management of risk factors, seromas remain a common clinical concern in the postoperative setting of total mastectomy. These results suggest that sclerosant agents, specifically bleomycin and doxycycline, have no utility for prevention of post mastectomy seroma.