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

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ClinicalTrials.gov Identifier: NCT00933829
Recruitment Status : Withdrawn
First Posted : July 7, 2009
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE July 2, 2009
First Posted Date  ICMJE July 7, 2009
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2009)
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. [ Time Frame: at least 3 months post-injury ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2009)
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. [ Time Frame: 8-12 days post-injury ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures
Official Title  ICMJE Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lacerations
  • Wounds
  • Injuries
Intervention  ICMJE
  • Procedure: Absorbable Suture Arm
    use of irradiated polyglactin 910
    Other Name: Vicryl Rapide
  • Device: Non-absorbable suture (Prolene)
    suture
  • Procedure: suture
    non-absorable sutures and absorable sutures
Study Arms  ICMJE
  • Placebo Comparator: Non-absorbable arm
    uses non-absorbable suture such as Prolene to repair lacerations
    Interventions:
    • Device: Non-absorbable suture (Prolene)
    • Procedure: suture
  • Active Comparator: Absorbable Suture Arm
    uses absorbable sutures to repair lacerations
    Interventions:
    • Procedure: Absorbable Suture Arm
    • Procedure: suture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 2, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2009)
160
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00933829
Other Study ID Numbers  ICMJE 12177
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raemma p Luck, MD Temple University
PRS Account Temple University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP