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)

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ObjectiveThe 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). BackgroundSeroma 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. MethodsThis 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. ResultsA 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%)). ConclusionsMastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.