TITLE:
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
AUTHORS:
Zackariah Clement, Peter Shin, Clive Hoffmann, Michael Eaton, William McLeay
KEYWORDS:
Breast Cancer, Mastectomy, Axillary Dissection, Seroma, Glubran, Cyanoacrylate Glue
JOURNAL NAME:
Advances in Breast Cancer Research,
Vol.6 No.4,
September
30,
2017
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.