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

Not Applicable

Withdrawn

• Conditions: Lacerations; Wounds; Injuries
• Interventions: Procedure: Absorbable Suture Arm; Device: Non-absorbable suture (Prolene); Procedure: suture

• Registration Number: NCT00933829
• Lead Sponsor: Temple University

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorbable Suture Arm	suture	uses absorbable sutures to repair lacerations
Absorbable Suture Arm	Absorbable Suture Arm	uses absorbable sutures to repair lacerations
Non-absorbable arm	Non-absorbable suture (Prolene)	uses non-absorbable suture such as Prolene to repair lacerations
Non-absorbable arm	suture	uses non-absorbable suture such as Prolene to repair lacerations

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.	8-12 days post-injury

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States