A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.

OBJECTIVE: To evaluate the safety and effectiveness of a lysine-derived urethane adhesive as a noninvasive alternative to closed suction drains in a commonly performed large flap surgical procedure. METHODS: One hundred thirty subjects undergoing abdominoplasty at five centers were prospectively randomized to standard flap closure with surgical drains (Control group) or a lysine-derived urethane adhesive (Treatment group) without drains. The primary outcome measured was the number of post-operative procedures, including drain removals (as the event marking the use of a surgical drain) and needle aspirations. Secondary endpoints included total wound drainage, cumulative days of treatment, and days to drain removal. A patient questionnaire evaluating quality of life measures was also administered. RESULTS: Subjects in the Treatment group required significantly fewer post-operative procedures compared to the Control group (1.8 ± 3.8 vs. 2.4 ± 1.2 procedures; p < 0.0001) and fewer cumulative days of treatment (1.6 ± 0.4 vs. 7.3 ± 3.3; p < 0.0001). A procedure to address fluid accumulation was required for only 27.3 % of the subjects in the Treatment group versus 100 % of Control group, which by study design required the use of drains. The mean duration of use of indwelling surgical drains for the Control group was 6.9 ± 3.3 days. All fluid collections treated with percutaneous aspiration were resolved and there were no unanticipated adverse events. CONCLUSION: The results of the study support that the use of a lysine-derived urethane adhesive is a safe and effective alternative to drains in patients undergoing a common large flap surgical procedure.