Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 10:07 AM
Study NCT ID:
NCT01918059
Status:
TERMINATED
Last Update Posted:
2014-12-03
First Post:
2013-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: