title: A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Division of Plastic Surgery, and the Hunstad Kortesis Center for Cosmetic Plastic Surgery and Med Spa, The University of North Carolina Chapel Hill, Huntersville, NC, USA.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Hunstad
authors.forename: Joseph
authors.initials: J
authors.lastname: Michaels
authors.forename: A Jay
authors.initials: AJ
authors.lastname: Burns
authors.forename: Sheri
authors.initials: S
authors.lastname: Slezak
authors.forename: W Grant
authors.initials: WG
authors.lastname: Stevens
authors.forename: Dottie M
authors.initials: DM
authors.lastname: Clower
authors.forename: J Peter
authors.initials: JP
authors.lastname: Rubin
mesh_terms: D000328:Adult; D004322:Drainage; D005260:Female; D006801:Humans; D008239:Lysine; D008297:Male; D011446:Prospective Studies; D019651:Plastic Surgery Procedures; D013524:Surgical Flaps; D014014:Tissue Adhesives; D014520:Urethane
chemical_list: D014014:Tissue Adhesives; D014520:Urethane; D008239:Lysine