Clinical Trial: Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair

Brief Summary: This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at two intervals after repair and later blindly assessed using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in across all three treatment arms.

Detailed Summary: This project is a randomized, controlled trial investigating the cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures (surgical gut suture), non-absorbable sutures (polypropylene suture), and tissue adhesive (octyl-2-cyanoacrylate). The population will include patients presenting to Memorial Hermann Hospital requiring repair of traumatic lid lacerations. The study will include partial thickness, full-thickness, and margin-involving lacerations where first standard layered tarsal and marginal suture repair will be performed if necessary, and then the patient will be randomized to superficial skin closure with either polypropylene suture closure, surgical gut suture closure, or tissue adhesive closure. Subjects will be followed in an outpatient setting at 1 week and 1 month post-repair at which time standardized photographs will be taken and later assessed using two standardized appearance assessment tools: Visual Analogue Scale (VAS) and Hollander Wound Evaluation Score (HWES).
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Cosmetic wound appearance [ Time Frame: 1 month after repair ]

Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: July 30, 2013
Date Started: August 2013
Date Completion:
Last Updated: December 2, 2014
Last Verified: December 2014