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

Pediatric Clinical Research Platform

Status: Enrolling

Conditions: Wounds and Injuries

Treatments: Device: Absorbable; Device: Non absorbable

Study type: Interventional

Funder types: Other

Identifiers

NCT02777346

CER 09-057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 day to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Absorbable

Experimental group

Description:

Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc).

Treatment:

Device: Absorbable

Non Absorbable

Active Comparator group

Description:

Suture material: Polypropylene thread (Prolene®, Ethicon Inc).

Treatment:

Device: Non absorbable