A Double-Blinded Prospective Randomised Controlled Trial to Assess the Efficacy of Glubran-2 in Reducing Seroma Formation after a Mastectomy with or without Axillary Dissection

Abstract

Background and Purpose: Seroma formation is a common complication following a mastectomy and axillary surgery. Decreasing the dead space is believed to decrease seroma formation. The aim of this study is to compare the incidence of seroma formation with the use of Glubran-2 versus normal saline during the wound closure in participants undergoing mastectomy with or without axillary dissection. Methods: This multicentre, prospective, double-blinded, randomised controlled trial, enrolled women 18 years of age or older with breast cancer, who were underwent total or partial mastectomy, with or without axillary dissection. Participants were randomised to Glubran-2 or Saline arm. The primary outcome was the volume and duration of wound seroma. Secondary outcome was post-operative wound infection. Results: A total of 76 women were randomised and there was no loss to follow-up or mortality. The total seroma volume was higher in the Glubran-2 arm. The duration of seroma was higher in the mastectomy and axillary dissection group in the Glubran-2 arm (P = 0.69). Elderly and participants with higher BMI had a higher volume of seroma. Post-operative infection rate was higher in the Glubran-2 arm (13.2% vs. 5.6%; P = 0.26). There was no statistically significant difference between the groups. Conclusion: Our study did not show any benefit with the use of Glubran-2 in mastectomy and axillary surgery in reducing the risk of seroma formation. In elderly and obese participants the use of Glubran-2 showed an increase in seroma formation and post-operative wound infection.