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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lacerations, Wounds, Injuries

Intervention / Treatment
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* Procedure: Absorbable Suture Arm
* Device: Non-absorbable suture (Prolene)
* Procedure: suture


Participation Criteria
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Eligibility Criteria
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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 Patients with allergic reaction to the topical anesthetic Irregular wounds

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-absorbable arm<br>uses non-absorbable suture such as Prolene to repair lacerations | Device: Non-absorbable suture (Prolene)<br>* suture<br>Procedure: suture<br>* non-absorable sutures and absorable sutures<br>|
| Active Comparator: Absorbable Suture Arm<br>uses absorbable sutures to repair lacerations | Procedure: Absorbable Suture Arm<br>* use of irradiated polyglactin 910<br>* Other names: Vicryl Rapide;Procedure: suture<br>* non-absorable sutures and absorable sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury. |  | 8-12 days post-injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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absorbable sutures, non-absorbable sutures, wound management