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

NCT ID: NCT02777346

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2025-02-06

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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Absorbable

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

Group Type: EXPERIMENTAL

Absorbable

Intervention Type: DEVICE

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.

Non Absorbable

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

Group Type: ACTIVE_COMPARATOR

Non absorbable

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Clinical Research Platform

OTHER

Sponsor Role: lead

Responsible Party

Giorgio La Scala

PD, MD; Attending Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giorgio La Scala, MD PD

Role: STUDY_DIRECTOR

University Hospital, Geneva

Locations

Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

CER 09-057

Identifier Type: -

Identifier Source: org_study_id