Clinical trial NCT02777346: Evaluation of Emergency Suturing with Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Official title: Evaluation of Emergency Suturing with Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wounds and Injuries
Keywords: WOUNDS, PENETRATING
CHILD, PRESCHOOL
CHILD
INFANT
ADOLESCENT
SUTURES
POLYGLACTIN 910
POLYPROPYLENES
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Short-term infection risk
timeFrame: 4 to 21 days
Secondary outcomes:
measure: Scar appearance
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Geneva University Hospital
state: Genève
Study officials:
affiliation: University Hospital, Geneva
name: Giorgio La Scala, MD PD
role: STUDY_DIRECTOR
References: