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Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
This study has been terminated.
(Recruitment difficulties)
Sponsor:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Judianne Kellaway, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01918059
First received: July 30, 2013
Last updated: December 2, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Eyelid Laceration | Procedure: Tissue Adhesive skin closure Procedure: Absorbable suture skin closure Procedure: Non-absorbable suture skin closure | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair |
Resource links provided by NLM:
Further study details as provided by Judianne Kellaway, The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- 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).
| Enrollment: | 4 |
| Study Start Date: | August 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Procedure: Non-absorbable suture skin closure
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with either non-absorbable sutures (6-0 polypropylene).
Other Names:
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Experimental: 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.
|
Procedure: Absorbable suture skin closure
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with absorbable sutures (surgical gut).
Other Names:
|
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Experimental: 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.
|
Procedure: Tissue Adhesive skin closure
The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with tissue adhesive (octyl-2-cyanoacrylate).
Other Names:
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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).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01918059
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918059
Locations
| United States, Texas | |
| Memorial Hermann Hospital - Texas Medical Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
| Principal Investigator: | Judianne Kellaway, MD | The University of Texas Health Science Center, Houston |
More Information
Publications:
| Responsible Party: | Judianne Kellaway, Clinical Associate Professor, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01918059 History of Changes |
| Other Study ID Numbers: |
HSC-MS-13-0276 |
| Study First Received: | July 30, 2013 |
| Last Updated: | December 2, 2014 |
Keywords provided by Judianne Kellaway, The University of Texas Health Science Center, Houston:
|
Trauma Eyelid Laceration Tissue adhesive |
suture cosmetic octyl-2-cyanoacrylate |
Additional relevant MeSH terms:
|
Lacerations Wounds and Injuries |
ClinicalTrials.gov processed this record on August 16, 2017