Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
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ClinicalTrials.gov Identifier: NCT01918059 |
Recruitment Status
:
Terminated
(Recruitment difficulties)
First Posted
: August 7, 2013
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eyelid Laceration | Procedure: Tissue Adhesive skin closure Procedure: Absorbable suture skin closure Procedure: Non-absorbable suture skin closure | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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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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- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918059
United States, Texas | |
Memorial Hermann Hospital - Texas Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Judianne Kellaway, MD | The University of Texas Health Science Center, Houston |
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 |
First Posted: | August 7, 2013 Key Record Dates |
Last Update Posted: | December 3, 2014 |
Last Verified: | December 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 |