NCT02777346

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Pediatric Clinical Research Platform · Academic / Other
• Sex: All
• Age: 1 Day – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Non 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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2016-05-19
• Last updated: 2025-07-04

Locations

1 site across 1 country: Switzerland