1. Lysine-urethane-based tissue adhesion for mastectomy—an approach to reducing the seroma rate?
- Author
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Boeer, B., Schneider, J., Schoenfisch, B., Röhm, C., Paepke, S., Oberlechner, E., Ohlinger, R., Hartkopf, A., Brucker, S. Y., Hahn, M., and Marx, M.
- Subjects
TISSUE adhesions ,MASTECTOMY ,QUALITY of life ,WOUND care ,POSTOPERATIVE pain - 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. [ABSTRACT FROM AUTHOR]- Published
- 2021
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