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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854407 | PMC |
| http://dx.doi.org/10.1007/s00404-020-05801-1 | DOI Listing |
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