Wounds and Injuries
Conditions
Keywords
WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES
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.
Interventions
DEVICEAbsorbable
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.
DEVICENon absorbable
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.
Sponsors
Pediatric Clinical Research Platform
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Days to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term infection risk | 4 to 21 days | Scars classified as no evidence of infection, signs of inflammation and signs of active infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar appearance | 6 months | Scoring based on the Manchester scar scale |
Countries
Switzerland
Outcome results
None listed