Trial record 7 of 111 for:    Open Studies | "Lacerations"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The University of Texas Health Science Center, Houston
Sponsor:
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: April 22, 2014
Last verified: April 2014
  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 skine closure
Procedure: Absorbable suture skin closure
Procedure: Non-absorbable suture skin closure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cosmetic wound appearance [ Time Frame: 1 month after repair ] [ Designated as safety issue: No ]
    Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).


Estimated Enrollment: 160
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (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:
  • 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 skine 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

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918059

Contacts
Contact: Helen A Merritt, MD 214-450-4503 helen.a.merritt@gmail.com

Locations
United States, Texas
Memorial Hermann Hospital - Texas Medical Center Recruiting
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: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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 July 20, 2014