Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wounds and Injuries
- Sponsor
- Pediatric Clinical Research Platform
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Short-term infection risk
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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:
- 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
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.
Investigators
Giorgio La Scala
PD, MD; Attending Surgeon
University Hospital, Geneva
Eligibility Criteria
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
Outcomes
Primary Outcomes
Short-term infection risk
Time Frame: 4 to 21 days
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
Secondary Outcomes
- Scar appearance(6 months)