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Clinical Trials/NCT00933829
NCT00933829
Withdrawn
Not Applicable

Comparison of Cosmetic Outcomes of Lacerations of the Trunk and Extremity Repaired Using Absorbable Versus Non-absorbable Sutures

Temple University1 site in 1 countryApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lacerations
Sponsor
Temple University
Locations
1
Primary Endpoint
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
September 2010
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Isolated injury
  • Non-contaminated or minimally contaminated wounds
  • Linear laceration 1-5 cms
  • Topical adhesives not indicated

Exclusion Criteria

  • Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
  • Moderately contaminated wounds or dirty wounds
  • Wounds with visible foreign bodies
  • Wounds more than 8 hours old
  • Wounds that can be repaired using topical adhesives
  • Complex wounds needing surgical referral
  • Wounds caused by mammalian bites
  • Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
  • Wounds in patients who are currently taking steroids
  • Wounds in areas of tension such as the joint or crease

Outcomes

Primary Outcomes

The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.

Time Frame: at least 3 months post-injury

Secondary Outcomes

  • Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.(8-12 days post-injury)

Study Sites (1)

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