Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00933829
First received: July 2, 2009
Last updated: September 24, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention
Lacerations
Wounds
Injuries
 Procedure: Absorbable Suture Arm
Device: Non-absorbable suture (Prolene)
Procedure: suture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:
  • The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale. [ Time Frame: at least 3 months post-injury ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. [ Time Frame: 8-12 days post-injury ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non-absorbable arm
uses non-absorbable suture such as Prolene to repair lacerations
 Procedure: Absorbable Suture Arm
use of irradiated polyglactin 910
Other Name: Vicryl Rapide
Procedure: suture
non-absorable sutures and absorable sutures
Active Comparator: Absorbable Suture Arm
uses absorbable sutures to repair lacerations
 Device: Non-absorbable suture (Prolene)
suture
Procedure: suture
non-absorable sutures and absorable sutures

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.

  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933829

Locations
United States, Pennsylvania
Temple University Hospital
PHiladelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Raemma p Luck, MD Temple University
  More Information

Additional Information:
abstract of Vicryl Rapide and RCT  This link exits the ClinicalTrials.gov site
Ethicon Product catalog  This link exits the ClinicalTrials.gov site
use of absorbable sutures in pediatric facial lacerations  This link exits the ClinicalTrials.gov site
review of wound management, sutures  This link exits the ClinicalTrials.gov site
wound evaluation scales  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Raemma Luck, MD, Temple University
ClinicalTrials.gov Identifier: NCT00933829     History of Changes
Other Study ID Numbers: 12177
Study First Received: July 2, 2009
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
absorbable sutures
non-absorbable sutures
wound management

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013