Seroma Reduction After Mastectomy

Summary

Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.

Timeline

Start

2014-06-01

Primary completion

2019-08-31

Completion

2019-08-31

Outcome

Met primary endpoint

paper 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). PMID 33078318 ↗

Publications

• Results van Bastelaar J, Beckers A, Snoeijs M, Beets G, Vissers Y. Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice. World J Surg Oncol. 2016 Mar 8;14:66. doi: 10.1186/s12957-016-0830-8.
• de Rooij L, van Kuijk SMJ, Granzier RWY, Hintzen KFH, Heymans C, Theunissen LLB, von Meyenfeldt EM, van Essen JA, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. 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. 2021 May;28(5):2599-2608. doi: 10.1245/s10434-020-09225-8. Epub 2020 Oct 19.
• van Bastelaar J, Granzier R, van Roozendaal LM, Beets G, Dirksen CD, Vissers Y. A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial. BMC Cancer. 2018 Aug 17;18(1):830. doi: 10.1186/s12885-018-4740-8.

Drugs

Indications