search
Back to results

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

Primary Purpose

Eyelid Laceration

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tissue Adhesive skin closure
Absorbable suture skin closure
Non-absorbable suture skin closure
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Laceration focused on measuring Trauma, Eyelid, Laceration, Tissue adhesive, suture, cosmetic, octyl-2-cyanoacrylate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Hermann Hospital - Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Non-absorbable suture skin closure

Absorbable suture skin closure

Tissue Adhesive skin closure

Arm Description

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.

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.

The superficial eyelid skin will be repaired with layers of tissue adhesive (octyl-2-cyanoacrylate) after repair of any deep component of the laceration.

Outcomes

Primary Outcome Measures

Cosmetic wound appearance
Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).

Secondary Outcome Measures

Full Information

First Posted
July 30, 2013
Last Updated
December 2, 2014
Sponsor
The University of Texas Health Science Center, Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT01918059
Brief Title
Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
Official Title
Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Laceration
Keywords
Trauma, Eyelid, Laceration, Tissue adhesive, suture, cosmetic, octyl-2-cyanoacrylate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-absorbable suture skin closure
Arm Type
Experimental
Arm Description
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.
Arm Title
Absorbable suture skin closure
Arm Type
Experimental
Arm Description
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.
Arm Title
Tissue Adhesive skin closure
Arm Type
Experimental
Arm Description
The superficial eyelid skin will be repaired with layers of tissue adhesive (octyl-2-cyanoacrylate) after repair of any deep component of the laceration.
Intervention Type
Procedure
Intervention Name(s)
Tissue Adhesive skin closure
Other Intervention Name(s)
octyl-2-cyanoacrylate, cyanoacrylate, tissue adhesive
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Absorbable suture skin closure
Other Intervention Name(s)
gut, surgical gut
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Non-absorbable suture skin closure
Other Intervention Name(s)
prolene, polypropylene
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cosmetic wound appearance
Description
Cosmetic appearance will be assessed using two wound assessment methods: the Visual Analogue Scale (VAS) and the Hollander Wound Evaluation Scale (HWES).
Time Frame
1 month after repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judianne Kellaway, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18090752
Citation
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.
Results Reference
background
PubMed Identifier
7893315
Citation
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.
Results Reference
background
PubMed Identifier
19769871
Citation
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.
Results Reference
background
PubMed Identifier
10937118
Citation
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.
Results Reference
background
PubMed Identifier
16364595
Citation
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.
Results Reference
background
PubMed Identifier
22442543
Citation
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.
Results Reference
background
PubMed Identifier
7741347
Citation
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. Erratum In: Ann Emerg Med 1995 Oct;26(4):532.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs