Can an internal surgical adhesive facilitate drain-free mastectomy and reduce overall invasiveness? – a prospective, randomized, controlled, multicenter non-inferiority trial

Introduction:

Mastectomy closure without drains has many potential advantages. Flap fixation techniques have shown to be an effective alternative to drains. This study tested the non-inferiority of a surgical adhesive in overall invasiveness compared to standard wound closure with drains.

Methods:

This trial (ClinicalTrials.gov Identifier: NCT02958449) recruited seventy-seven patients undergoing eighty-four mastectomies +/- SLNB (n = 84) at eleven international centers. Procedures were prospectively randomized to standard wound closure with drains (SWC; n = 41) or wound closure without drains using a high strength lysine-based adhesive named TissuGlu® (TG; n = 43). The primary outcome measured assessed overall invasiveness using the number of post-operative clinical interventions, including drain removals and needle aspirations. Secondary endpoints included total wound drainage, cumulative days of treatment, days to drain removal and wound healing related complications. A patient questionnaire evaluating quality of life measures was also administered.

Results:

Subjects in the TissuGlu® group required significantly fewer post-operative clinical interventions (1.25 ± 1.39 TG vs. 2.03 ± 1.45 SWC, p =< 0.0001) compared to the Control group and had fewer cumulative days of treatment (defined as days of drains being in place and/or days on which an aspiration occurred; 2.14 ± 4.15 TG vs. 5.76 ± 4.02 SWC, p =< 0.0001). Presence of a drain was associated with significantly higher pain and lower mobility scores.

Conclusion:

The study demonstrates that flap fixation with this adhesive can permit drain-free mastectomy closure, reducing overall invasiveness and patient morbidity.