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Aesthetic Plast Surg. 2015 Aug;39(4):616-24. doi: 10.1007/s00266-015-0498-4. Epub 2015 Jun 5.

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

Author information

1
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.

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.

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.

PMID:
26044391
PMCID:
PMC4503854
DOI:
10.1007/s00266-015-0498-4
[Indexed for MEDLINE]
Free PMC Article

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