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

Phase 4

Terminated

• Conditions: Eyelid Laceration
• Interventions: Procedure: Non-absorbable suture skin closure; Procedure: Absorbable suture skin closure; Procedure: Tissue Adhesive skin closure

• Registration Number: NCT01918059
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 Timeline

• Study First Submitted: 2013-07-30
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 18 years of age or older.
• Any laceration caused by trauma and involving the skin of the upper and/or lower eyelid.
• Must be able to understand and sign an informed consent when applicable and Health Insurance Portability and Accountability Act(HIPAA) form that has been approved by an Institutional Review Board (IRB) or follow standard informed consent procedure of the IRB

Exclusion Criteria

• Eyelid lacerations that include avulsion or missing eyelid tissue
• Patients with known hypersensitivity to octyl-2-cyanoacrylate or previous poor reaction to octyl-2-cyanoacrylate
• Eyelid lacerations resulting in necrosis or ischemia of tissue prior to repair
• Patients who demonstrate intoxication or mental status changes that would make them unfit to provide informed consent for repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-absorbable suture skin closure	Non-absorbable suture skin closure	The superficial eyelid skin will be repaired with simple interrupted sutures with non-absorbable suture (6-0 polypropylene) after repair of any deep component of the laceration.
Absorbable suture skin closure	Absorbable suture skin closure	The superficial eyelid skin will be repaired with simple interrupted sutures with absorbable suture (surgical gut) after repair of any deep component of the laceration.
Tissue Adhesive skin closure	Tissue Adhesive skin closure	The superficial eyelid skin will be repaired with layers of tissue adhesive (octyl-2-cyanoacrylate) after repair of any deep component of the laceration.

Primary Outcome Measures

Name	Time	Method
Cosmetic wound appearance	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).

Trial Locations

Locations (1)

Memorial Hermann Hospital - Texas Medical Center; 🇺🇸 Houston, Texas, United States