Lysine-urethane-based tissue adhesion for mastectomy-an approach to reducing the seroma rate?

Arch Gynecol Obstet. 2021 Jan;303(1):181-188. doi: 10.1007/s00404-020-05801-1. Epub 2020 Nov 4.

Abstract

Purpose: Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu® without drainage is equal/ non-inferior to standard mastecomy with drainage.

Methods: The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups.

Results: Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu® compared to standard drainage couldn't be reached.

Discussion: The present evaluation shows no advantage of the tissue adhesive TissuGlu® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Keywords: Breast cancer therapy; Drainage; Seroma formation; Surgical adhesive; TissuGlu®.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery*
  • Drainage / methods
  • Female
  • Humans
  • Lysine / chemistry
  • Mastectomy / methods*
  • Middle Aged
  • Plastic Surgery Procedures / adverse effects*
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Quality of Life
  • Seroma / epidemiology
  • Seroma / etiology
  • Seroma / prevention & control*
  • Surgical Tape*
  • Suture Techniques / adverse effects*
  • Tissue Adhesions
  • Tissue Adhesives / chemistry
  • Tissue Adhesives / therapeutic use*
  • Treatment Outcome
  • Urethane / chemistry

Substances

  • Tissue Adhesives
  • Urethane
  • Lysine