Fibrin sealant versus autologous Platelet-Rich Plasma for prevention of seroma after breast cancer surgery: An exploratory randomized controlled trial

Abstract

Background: Seroma remains a frequent postoperative complication after breast cancer surgery, particularly following mastectomy and axillary lymph node dissection. Fibrin sealants may limit lymphatic leakage and dead space, whereas autologous platelet-rich plasma (PRP) may promote tissue repair. Direct randomized comparisons of these approaches are limited. Patients and Methods: This single-center, two-arm exploratory randomized controlled trial enrolled 50 women undergoing breast cancer surgery between December 2024 and December 2025. Participants were allocated 1:1 to topical fibrin sealant (n=25) or autologous PRP (n=25) applied to the operative bed before closure. The primary outcomes were clinically significant seroma incidence and postoperative fluid volume. Secondary outcomes included postoperative discomfort, therapeutic aspiration, time to functional recovery, and intervention-related adverse events. Analyses followed the intention-to-treat principle. Results: Clinically significant seroma occurred in 4/25 participants (16.0%) in the fibrin-sealant group and 5/25 (20.0%) in the PRP group (RR 0.80, 95% CI 0.24-2.64; Fisher exact P=1.000). Median postoperative fluid volume was lower with fibrin sealant (15.3 mL [IQR 13.8-16.8]) than with PRP (18.7 mL [IQR 16.7-20.7]; P<0.001). Median discomfort scores were 2.1 versus 2.4 (P<0.001), and median time to return to normal activities was 15 versus 16 days (P<0.001), respectively; both differences were small in magnitude. Therapeutic aspiration was required in 4 versus 5 participants. No intervention-related adverse events were documented during the 2-month follow-up. Conclusions: Fibrin sealant and autologous PRP were associated with similar rates of clinically significant seroma. Fibrin sealant was associated with lower postoperative fluid accumulation and small differences in short-term recovery outcomes. Given the exploratory design, small sample size, absence of an a priori power calculation, and lack of prospective public trial registration, the findings should be considered hypothesis-generating rather than definitive evidence of superiority.