Abstract P2-14-03: Mastectomy without drains: Flap adhesion and closure of dead space using TissuGlu® vs standard wound closure (SWC) - a parallel cohort comparison
Authors: Paepke Stefan 
Published: May 2015

Abstract
Background: Mastectomy(ME) remains associated with high rates of minor complications and occasional revision surgery for wound healing/seroma. Closed suction drain use in an effort to reduce seroma related complications is the current standard procedure but drain efficacy has been contested in multiple reports. Mechanical closure of dead space with suturing techniques has been shown to be effective but this is often not practical in these patients and increases operating time. Fibrin sealants may reduce early drainage volume but have not been shown to allow elimination of drains. Recent reports have shown that closure of dead space can be achieved through the use of a new resorbable surgical adhesive (TissuGlu®, Cohera Medical, Pittsburgh) allowing for the elimination of drain use in that procedure. Our work with this adhesive began in 2013, with use initially limited to revisions and patients at high risk of postoperative complications; later extended use to ME in the general patient population without drain placement. Here we present the results of our prospective observation of postoperative outcomes in this early series.
Materials & Methods: A parallel cohort comparison was performed for non-inferiority of TG/No Drains vs. SWC with respect to postoperative fluid management and seroma related complications. All primary ME +/- SLNB and/or ALND were prospectively documented for operative procedure variables and outcomes, including male patients and bilateral cases. 56 MEs patients (66 MEs) from Feb 2013 through Feb 2014 were documented and analyzed. Total drained volume, aspirations, minor wound healing complications and need for revision surgery were compared.
Results: Patient demographics and procedure variables were comparable in the two groups.
Patient demographics & procedure variablesPt demographics & procedure variablesSWC TG/NDPatients35 21Mean Age61.5 62.7Mean BMI25.7 25.7
Mean total drained + aspirated fluid per ME was 78 ml in the TG/No Drain group vs. 512 ml in the SWC group, an 85% reduction (p=0.00). Four MEs required aspiration in the test group (15%) vs. 10 (25%) in the SWC group (ns). There were 3 revisions in the SWC group and none in the test group (ns).
OutcomesOutcomesSWC TG/ND p value Number (mastectomies)40 26 Mean Days with drains6.4 0 -100% Mean Total Drained Volume/mast. (ml)463 0 -100% Mean Total Drained + Aspirated (ml)/mast512 78 0.000-85%Mann-WhitneyNumber (%) of mast. aspirated1025%415%0.539-38%Fisher's Exact due to Small # of incidenceNumber (%) of mast. w minor complications1333%727%0.625-17%two proportionNumber (%) of mast. Requiring revision38%-0%0.273-100%Fisher's Exact Due to Small # of incidence
Discussion/Conclusions: Our experience suggests a clear advantage in the TG/no-drain approach in mastectomy. In addition to the improved patient comfort and earlier discharge with TG, patients with drains had significantly higher total fluid collection and still required more aspirations on average than the test group. Non-inferiority for minor complications was not only achieved, but there seems to be a trend toward reduced complications in the no drain cohort. A prospective, randomized study is planned to verify our initial impressions.
Citation Format: Stefan Paepke. Mastectomy without drains: Flap adhesion and closure of dead space using TissuGlu® vs standard wound closure (SWC) - a parallel cohort comparison [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-14-03.