Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population

Study Overview
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Brief Summary
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The investigators recruit patients admitted to the Pediatric Emergency Department of the Geneva's University Hospital with open wounds needing suture. The patients are treated with absorbable versus non-absorbable suture material according to randomization. Outcomes are: infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol) scar appearance at a 6-months follow-up.

Detailed Description
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The investigators recruit patients admitted to the Pediatric Emergency Department of the Geneva's University Hospital with open wounds needing suture. The patients are treated with absorbable versus non-absorbable suture material according to randomization. After obtaining the patient's/parent's consent and randomization, the suture material will be provided. Selection of the size of the thread and the date of the first follow-up are determined as follows: Face: Thread size 5-0 to 7-0, first follow-up 4-7 days Torso/back: Thread size 4-0 or 5-0, first follow-up 10-14 days Arms: Thread size 4-0 or 5-0, first follow-up 7- 10 days Hand: Thread size 5-0 or 6-0, first follow-up 7-10 days Legs: Thread size 4-0 or 5-0, first follow-up 7-14 days The patients are examined by in the outpatient wound clinic by specialised nurses under medical supervision at the first follow-up, and at six months by one of the investigators. Outcomes: infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol) scar appearance at a 6-months follow-up.

Official Title
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Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Absorbable
* Device: Non absorbable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient younger than 16 years of age with a wound requiring suture Exclusion Criteria: Deep wounds with lesions of subcutaneous structures (tendons, nerves, etc.) Wounds with tissue loss Diabetic patients or patients treated with drugs potentially compromising cicatrization (e.g. steroids, immunosuppressors, etc.) Wounds caused by animal or human bites Sutures not performed in the emergency room Heavily soiled wounds

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable<br>Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc). | Device: Absorbable<br>* Wound suture by a resident physician. Two follow-up appointments (first at 4 to 21 days after the suture, according to the sutured site as defined by protocol, second at 6 months) Standardized photography of the wound before the suture and at the two subsequent follow-ups. Evaluation of the scar with a standardised form by a specialised nurse under medical supervision at the first follow-up and by a panel of investigators at 6 months using the pictures taken at the follow-up appointments.<br>|
| Active Comparator: Non Absorbable<br>Suture material: Polypropylene thread (Prolene®, Ethicon Inc). | Device: Non absorbable<br>* Wound suture by a resident physician. Two follow-up appointments (first at 4 to 21 days after the suture, according to the sutured site as defined by protocol, second at 6 months) Standardized photography of the wound before the suture and at the two subsequent follow-ups. Evaluation of the scar with a standardised form by a specialised nurse under medical supervision at the first follow-up and by a panel of investigators at 6 months using the pictures taken at the follow-up appointments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term infection risk | Scars classified as no evidence of infection, signs of inflammation and signs of active infection | 4 to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance | Scoring based on the Manchester scar scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES