Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind R
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ORIGINAL ARTICLE – BREAST ONCOLOGY
Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial) L. de Rooij, MD1 , S. M. J. van Kuijk, PhD2, R. W. Y. Granzier, MD1, K. F. H. Hintzen, MD1, C. Heymans, MD1, L. L. B. Theunissen, MD1, E. M. von Meyenfeldt, MD3, J. A. van Essen, MD4, E. R. M. van Haaren, MD1, A. Janssen, MD1, Y. L. J. Vissers, MD, PhD1, G. L. Beets, MD, PhD5,6, and J. van Bastelaar, MD, PhD1 Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands; 2Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands; 3Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands; 4Department of Surgery, St. Jans Gasthuis Hospital, Weert, The Netherlands; 5Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands; 6GROW School for Oncology and Developmental Biology, University of Maastricht, Maastricht, The Netherlands
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ABSTRACT Background. Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae. Methods. Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient
Electronic supplementary material The online version of this article (https://doi.org/10.1245/s10434-020-09225-8) contains supplementary material, which is available to authorized users. Society of Surgical Oncology 2020 First Received: 2 June 2020 Accepted: 17 September 2020 L. de Rooij, M.D. e-mail: [email protected]
department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores. Results. Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16–0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skindimpling, or postoperative pain. Conclusion. Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly
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