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Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures

Sponsor
Temple University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00933829
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
17
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Absorbable Suture Arm
  • Device: Non-absorbable suture (Prolene)
  • Procedure: suture
 N/A

Detailed Description

Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Non-absorbable arm

uses non-absorbable suture such as Prolene to repair lacerations

Device: Non-absorbable suture (Prolene)
suture

Procedure: suture
non-absorable sutures and absorable sutures
Active Comparator: Absorbable Suture Arm

uses absorbable sutures to repair lacerations

Procedure: Absorbable Suture Arm
use of irradiated polyglactin 910
Other Names:
  • Vicryl Rapide

    • Procedure: suture
    non-absorable sutures and absorable sutures

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. [at least 3 months post-injury]

    Secondary Outcome Measures

    1. Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. [8-12 days post-injury]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Isolated injury

    2. Non-contaminated or minimally contaminated wounds

    3. Linear laceration 1-5 cms

    4. Topical adhesives not indicated

    Exclusion Criteria:

    1. Trunk and extremity lacerations less than 1 cm or greater than 5 cm.

    2. Moderately contaminated wounds or dirty wounds

    3. Wounds with visible foreign bodies

    4. Wounds more than 8 hours old

    5. Wounds that can be repaired using topical adhesives

    6. Complex wounds needing surgical referral

    7. Wounds caused by mammalian bites

    8. Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction

    9. Wounds in patients who are currently taking steroids

    10. Wounds in areas of tension such as the joint or crease

    11. Patients with allergic reaction to the topical anesthetic

    12. Irregular wounds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Temple University Hospital Philadelphia Pennsylvania United States 19140

    Sponsors and Collaborators

    • Temple University

    Investigators

    • Principal Investigator: Raemma p Luck, MD, Temple University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT00933829
    Other Study ID Numbers:
    • 12177
    First Posted:
    Jul 7, 2009
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020
    Keywords provided by Temple University
    absorbable sutures
    non-absorbable sutures
    wound management
    Additional relevant MeSH terms:
    Lacerations

    Study Results

    No Results Posted as of Jun 4, 2020