Publications

Can internal surgical adhesive facilitate drain-free mastectomy?

Published Date: 15th August 2018

Publication Authors: Kiernan T

​Introduction

Mastectomy closure without drains has many potential advantages. This study compares a lysine-based high strength adhesive with standard wound drain application. 

Methods

An ethically approved post-market non-inferiority multicentre randomized trial compared standard closure with drains (SWC) vs drain-free closure with adhesive (DFTG) in mastectomy +/-SLNB. Primary outcome was the number of post-operative clinical interventions, including drain removal and aspirations. Secondary endpoints included total wound drainage and patient satisfaction. A QOL patient questionnaire was administered at multiple follow-up visits. 

Results

77 mastectomy subjects across 11 centres were randomized. 7 subjects were excluded for subsequent ALND or dropped out. Results of the 70 PP subjects are in the table below. Values are Mean +/- SD (Min, Median, Max). Patient satisfaction was higher and pain scores were lower in the DFTG group Table 1. 

Conclusion

Drain-free mastectomy closure with TissuGlu leads to no overall increased invasiveness compared to drain use and is preferable to the patients. Further investigation comparing DFTG to mastectomy closure without drains and without flap fixation would be appropriate as a next step.

 

King, P; Kiernan, T et al. (2018). Can internal surgical adhesive facilitate drain-free mastectomy? A randomized, prospective multicenter non-inferiority clinical study comparing wound closure with drains to wound closure with tissuglu and no drains in mastectomy. European Journal of Surgical Oncology. 44 (6), 914

« Back