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

• Published in: Aesthetic plastic surgery Vol. 39; no. 4; pp. 616 - 624
• Main Authors: Hunstad, Joseph P., Michaels, Joseph, Burns, A. Jay, Slezak, Sheri, Stevens, W. Grant, Clower, Dottie M., Rubin, J. Peter
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.08.2015; Springer Nature B.V
• Subjects: Adult; Drainage; Female; Humans; Lysine; Male; Medicine; Medicine & Public Health; Original; Original Article; Otorhinolaryngology; Plastic Surgery; Plastic Surgery Procedures; Prospective Studies; Surgical Flaps; Tissue Adhesives; Urethane; Flap surgery; TissuGlu; Seroma; Abdominoplasty; Adhesive; Drains
• ISSN: 0364-216X; 1432-5241
• DOI: 10.1007/s00266-015-0498-4

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. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .