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

Temple University

Status: Withdrawn

Conditions: Injuries; Lacerations; Wounds

Treatments: Device: Non-absorbable suture (Prolene); Procedure: suture; Procedure: Absorbable Suture Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT00933829

12177 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Non-absorbable arm

Placebo Comparator group

Description:

uses non-absorbable suture such as Prolene to repair lacerations

Treatment:

Procedure: suture

Device: Non-absorbable suture (Prolene)

Absorbable Suture Arm

Active Comparator group

Description:

uses absorbable sutures to repair lacerations

Treatment:

Procedure: Absorbable Suture Arm

Procedure: suture