Clincosm LogoSign in Get a demo

Catgut: Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT00681070
Collaborator
(none)
74
Enrollment
2
Locations
2
Arms
29
Actual Duration (Months)
37
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm 2: Absorbable sutures
  • Other: Arm 1: non-absorbable sutures
 N/A

Detailed Description

The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.

In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
Actual Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm1: Non-absorbable sutures

use of non-absorbable sutures in facial laceration in this arm

Other: Arm 1: non-absorbable sutures
Use of non-absorbing sutures
Active Comparator: Arm 2: Absorbable sutures

use of absorbable sutures in this arm

Other: Arm 2: Absorbable sutures
use of absorbable catgut sutures in pediatric facial lacerations
Other Names:
  • fast-absorbing catgut 5-0 by Johnson and Johnson

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cosmetic outcomes [3 months]

    Secondary Outcome Measures

    1. infection [4-6 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair
    Exclusion Criteria:

    • Pregnancy

    • Bleeding

    • Renal

    • Endocrine problems

    • Dirty wounds

    • Irregular wounds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardinal Glennon Children's Hospital St. Louis Missouri United States 63104
    2 Temple University Hospital Philadelphia Pennsylvania United States 19130

    Sponsors and Collaborators

    • Temple University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT00681070
    Other Study ID Numbers:
    • 11020
    • 11020-2
    First Posted:
    May 21, 2008
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Temple University
    laceration
    wound management
    absorbable sutures
    cosmetic outcomes
    Additional relevant MeSH terms:
    Lacerations

    Study Results

    No Results Posted as of Feb 10, 2017