BACKGROUND AND OBJECTIVES Postoperative seroma after axillary lymphadenectomy leads to an increased use of resources and an impaired quality of life of patients. This randomized clinical trial was designed to assess the value of a hemostatic and sealing agent for decreasing seroma occurrence after axillary lymphadenectomy. METHODS A prospective, randomized, blind study was conducted on 91 axillary lymphadenectomies distributed into
a control group (n = 47) and a test group in which a collagen sponge coated with human coagulation factors was used (n = 44). Primary end-points were number of days before removal of axillary drainage, axillary drainage output, and occurrence of seroma, wound infection, haematoma, or wound dehiscence, within 8 weeks of surgery. Bivariate and multivariate analyses on seroma occurrence were performed. RESULTS Seroma occurred in 29 patients (31.86%). A significant direct relationship (P = 0.002) was only noted between use of the hemostatic and sealing agent and nonoccurrence of seroma. In the multivariate study, the only variable found to be significantly related to seroma occurrence was use of the above agent (P = 0.046; odds ratio: 3.365 [95%CI: 1.024-11.060]). CONCLUSIONS Use of a collagen sponge coated with human coagulation factors following axillary lymphadenectomy was associated to a lower incidence of postoperative seroma. J. Surg. Oncol. (c) 2016 Wiley Periodicals, Inc.