Reducing seroma formation and its sequelae after mastectomy by closure of the dead space: The interim analysis of a multi-center, double-blind randomized controlled trial (SAM trial)

• Published in: Breast (Edinburgh) Vol. 46; pp. 81 - 86
• Main Authors: Granzier, Renée W.Y., van Bastelaar, James, van Kuijk, Sander M.J., Hintzen, Kim F.H., Heymans, Cathelijne, Theunissen, Lotte L.B., van Haaren, Els R.M., Janssen, Alfred, Beets, Geerard L., Vissers, Yvonne L.J.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01-08-2019
• Subjects: 14-T-21; Adhesives; Adult; Breast cancer; Breast Neoplasms - surgery; Double-Blind Method; Drainage - statistics & numerical data; Female; Flap fixation; Humans; Mastectomy; Mastectomy - adverse effects; Mastectomy - methods; Middle Aged; Postoperative Complications - epidemiology; Postoperative Complications - prevention & control; Postoperative Complications - therapy; Respiratory Dead Space; Seroma; Seroma - epidemiology; Seroma - prevention & control; Seroma - therapy; Surgical Flaps; Suture Techniques; Treatment Outcome; Mastectomy; Breast cancer; Seroma; 14-T-21; Flap fixation
• ISSN: 0960-9776; 1532-3080
• DOI: 10.1016/j.breast.2019.05.002

The main objective of this double-blind randomized controlled trial (RCT) was to assess seroma formation and its sequelae in patients undergoing mastectomy. Patients were randomized into one of three groups in which different wound closure techniques were applied: 1) conventional wound closure without flap fixation (CON) 2) flap fixation using sutures (FF–S) and 3) flap fixation using an adhesive tissue glue (FF-G).
Seroma formation is still a bothersome complication after mastectomy. Flap fixation seems promising in reducing seroma formation. Various flap fixation techniques remain to be analyzed, including long-term outcome measures.
This trial was conducted in three different hospitals between June 2014 and November 2016. Patients were allocated to one of three groups. The primary outcome was the number of seroma needle aspirations. Secondary outcomes were (surgical site) infections, number of outpatient clinic visits, shoulder function, postoperative pain, patient-reported cosmesis and skin dimpling.
A total of 187 patients were randomly assigned to CON (n = 61), FF-S (n = 64) and FF-G (n = 62). The number of seroma aspirations was significantly higher in CON when compared to both flap fixation groups (p = 0.032), with no difference between FF-S and FF-G. Secondary outcomes showed no statistical differences between all groups. The higher number of outpatient clinic visits in CON was considered to be of clinical importance (CON = 27 (44.3%), FF-S = 19 (30.6%) and FF-G = 21 (34.4%)).
Mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.
•Mastectomy followed by flap fixation reduces the number of seroma aspirations.•Flap fixation with either sutures or adhesive tissue glue is equally effective.•Flap fixation has no negative effect on shoulder function, skin dimpling or cosmesis.