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).

OBJECTIVE: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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%)). CONCLUSIONS: Mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.

Flap Fixation Using Tissue Glue or Sutures Appears to Reduce Seroma Aspiration After Mastectomy for Breast Cancer.

BACKGROUND: Up to 90% of patients undergoing breast cancer surgery suffer from seroma formation, which can cause discomfort and various complications after mastectomy. This retrospective observational cohort study aimed to elucidate whether flap fixation with fibrin sealant (ARTISS) tissue glue reduces seroma formation and seroma aspiration after mastectomy when compared with flap fixation using Vicryl sutures and when compared with a conventional wound closure technique. METHODS: All patients undergoing mastectomy due to invasive breast cancer or ductal carcinoma in situ were eligible for inclusion. From May 2012 to March 2013, all patients undergoing mastectomy in 2 large breast cancer centers were treated using flap fixation with Vicryl sutures. From September 2013 to March 2014, all patients undergoing mastectomy were treated with flap fixation using ARTISS tissue glue. The data were retrospectively analyzed and compared with a "drain-only" group that was not treated with flap fixation (May 2011-March 2012). RESULTS: A total of 230 women who underwent mastectomy were retrospectively analyzed in this trial; 88 patients were included in the drain-only group (DO), 92 patients were included in the flap fixation group using Vicryl sutures (FF-1), and 50 patients were included in the flap fixation group using ARTISS tissue glue (FF-2). There was significantly less seroma formation in the group after flap fixation using sutures (P = .006). There were significantly fewer patients who required seroma aspiration in the FF-1 group (P = .001) and the FF-2 group (P = .001) after undergoing mastectomy and sentinel node biopsy or modified radical mastectomy. CONCLUSION: This study suggests that flap fixation after mastectomy using ARTISS tissue glue or sutures reduces postoperative seroma aspiration. As a result, flap fixation might lead to less patient discomfort. A randomized, prospective trial should be performed to verify these results.