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Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial)

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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 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, skin-dimpling, or postoperative pain.

Conclusion

Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757).

Preregistration

The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.

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Data Availability

The datasets during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Authors and Affiliations

  1. Department of Surgery, Zuyderland Medical Center, Sittard, The Netherlands

    L. de Rooij MD, R. W. Y. Granzier MD, K. F. H. Hintzen MD, C. Heymans MD, L. L. B. Theunissen MD, E. R. M. van Haaren MD, A. Janssen MD, Y. L. J. Vissers MD, PhD & J. van Bastelaar MD, PhD

  2. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands

    S. M. J. van Kuijk PhD

  3. Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands

    E. M. von Meyenfeldt MD

  4. Department of Surgery, St. Jans Gasthuis Hospital, Weert, The Netherlands

    J. A. van Essen MD

  5. Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands

    G. L. Beets MD, PhD

  6. GROW School for Oncology and Developmental Biology, University of Maastricht, Maastricht, The Netherlands

    G. L. Beets MD, PhD

Authors
  1. L. de Rooij MD
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  2. S. M. J. van Kuijk PhD
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  3. R. W. Y. Granzier MD
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  4. K. F. H. Hintzen MD
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  6. L. L. B. Theunissen MD
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  8. J. A. van Essen MD
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  10. A. Janssen MD
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  11. Y. L. J. Vissers MD, PhD
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  12. G. L. Beets MD, PhD
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  13. J. van Bastelaar MD, PhD
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Corresponding author

Correspondence to L. de Rooij MD.

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de Rooij, L., van Kuijk, S.M.J., Granzier, R.W.Y. et al. Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial). Ann Surg Oncol 28, 2599–2608 (2021). https://doi.org/10.1245/s10434-020-09225-8

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  • DOI: https://doi.org/10.1245/s10434-020-09225-8

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