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

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.