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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00933829
• Other study ID #: 12177
• Status: Withdrawn
• Phase: N/A
• Start date: April 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Injuries
• Lacerations
• Wounds

Intervention

Procedure:
• Absorbable Suture Arm
use of irradiated polyglactin 910

Device:
• Non-absorbable suture (Prolene)
suture

Procedure:
• suture
non-absorable sutures and absorable sutures

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005 Feb;30(1):90-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.		at least 3 months post-injury
Secondary	Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.		8-12 days post-injury

External Links

•   abstract of Vicryl Rapide and RCT
•   Ethicon Product catalog
•   review of wound management, sutures
•   use of absorbable sutures in pediatric facial lacerations