Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
NCT ID: NCT01918059
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
4 participants
INTERVENTIONAL
2013-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
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.
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).
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.
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).
Interventions
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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).
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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Judianne Kellaway
Clinical Associate Professor
Principal Investigators
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Judianne Kellaway, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States
Countries
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References
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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):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
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. doi: 10.1016/0735-6757(95)90100-0.
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. doi: 10.1001/archfaci.1.4.292.
Handschel JG, Depprich RA, Dirksen D, Runte C, Zimmermann A, Kubler 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. doi: 10.1016/j.ijom.2005.10.003. 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. doi: 10.1016/s0196-0644(95)70183-4.
Other Identifiers
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HSC-MS-13-0276
Identifier Type: -
Identifier Source: org_study_id