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

Sponsor:

Information provided by (Responsible Party):

Judianne Kellaway, The University of Texas Health Science Center, Houston

Study Description

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.

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

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Tears

U.S. FDA Resources

Arms and Interventions

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.	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: prolene polypropylene
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: gut surgical gut
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: octyl-2-cyanoacrylate cyanoacrylate tissue adhesive

Outcome Measures

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).

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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:

Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-7.

Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31.

Gilbert L, Pogorzalek N, Jounda G, Barreau E. [Traumatic peri-ocular injuries: closing wounds using 2-octyl-cyanoacrylate medical glue]. J Fr Ophtalmol. 2009 May;32(5):341-7. doi: 10.1016/j.jfo.2009.03.024. Epub 2009 May 17. French.

Greene D, Koch RJ, Goode RL. Efficacy of octyl-2-cyanoacrylate tissue glue in blepharoplasty. A prospective controlled study of wound-healing characteristics. Arch Facial Plast Surg. 1999 Oct-Dec;1(4):292-6.

Handschel JG, Depprich RA, Dirksen D, Runte C, Zimmermann A, Kübler NR. A prospective comparison of octyl-2-cyanoacrylate and suture in standardized facial wounds. Int J Oral Maxillofac Surg. 2006 Apr;35(4):318-23. Epub 2005 Dec 20.

Shivamurthy DM, Singh S, Reddy S. Comparison of octyl-2-cyanoacrylate and conventional sutures in facial skin closure. Natl J Maxillofac Surg. 2010 Jan;1(1):15-9. doi: 10.4103/0975-5950.69151.

Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. Erratum in: Ann Emerg Med 1995 Oct;26(4):532.


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

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