Efficacy of Flat-Silicone Versus Round-Silicone Perforated Drains in Seroma Formation and Other Outcomes Following Mastectomy: A Single-Blinded Randomized Controlled Trial.

Abstract

Seroma formation is a prevalent complication following mastectomy, causing significant discomfort and morbidity. Despite advancements in surgical techniques, optimal postoperative management of seroma remains challenging. This study compares the efficacy of two commonly used surgical drains, flat-silicone drains and round-silicone perforated drains in reducing prolonged seroma formation, and evaluates associated patient outcomes such as pain and wound complications. This open-labeled, single-blinded, randomized controlled trial was conducted at the Universiti Malaya Medical Center from August 2022 to August 2023. Patients undergoing mastectomy were allocated to receive either flat-silicone or round-silicone perforated drains. Data collected encompassed baseline demographics, surgical details, and postoperative outcomes. Pain assessments were conducted on postoperative Day 3 and during drain removal using an 11-point numeric rating scale (NRS). Complications such as blocked drains, surgical site infections, hematoma, and skin necrosis were documented. Statistical analyses were conducted using SPSS version 27.0, following the intention-to-treat principle. Categorical variables were analyzed with the chi-squared test. Continuous variables underwent normality assessment via the Shapiro-Wilk test; those with normal distribution were compared using the Student's t-test, whereas nonnormally distributed variables were evaluated using the Mann-Whitney U-test. A p-value of less than 0.05 was considered statistically significant. Prolonged seroma was observed in 32.5% of patients in the flat-silicone drain group and 37.5% in the round-silicone perforated drain group, with no statistically significant difference (p = 0.639). However, pain scores were significantly lower in the flat-silicone drain group at all time points: Day 3 (p = 0.041), before removal (p = 0.003), and during removal (p = 0.004). Both groups showed low and comparable rates of wound complications, including infections and blocked drains. Although both drain types demonstrated similar efficacy in managing prolonged seroma, the flat-silicone drain offered a significant advantage in reducing patient pain during the postoperative period. These findings suggest that flat-silicone drain may enhance patient comfort and satisfaction, underscoring the importance of considering patient-centered outcomes in surgical care.