Evaluation of Emergency Suturing with Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
- Conditions
- Wounds and Injuries
- Interventions
- Device: AbsorbableDevice: Non absorbable
- Registration Number
- NCT02777346
- Lead Sponsor
- Pediatric Clinical Research Platform
- Brief Summary
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:
1. infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
2. scar appearance at a 6-months follow-up.
- Detailed Description
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:
1. infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
2. scar appearance at a 6-months follow-up.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Patient younger than 16 years of age with a wound requiring suture
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Absorbable Absorbable Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc). Non Absorbable Non absorbable Suture material: Polypropylene thread (Prolene®, Ethicon Inc).
- Primary Outcome Measures
Name Time Method Short-term infection risk 4 to 21 days Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
- Secondary Outcome Measures
Name Time Method Scar appearance 6 months Scoring based on the Manchester scar scale
Trial Locations
- Locations (1)
Geneva University Hospital
🇨🇭Geneve, Genève, Switzerland