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

NCT02777346 | Completed

• 1 other identifier: CER 09-057
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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. 1.infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
2. 2.scar appearance at a 6-months follow-up.

Conditions

Wounds and Injuries

Keywords

WOUNDS, PENETRATING; CHILD, PRESCHOOL; CHILD; INFANT; ADOLESCENT; SUTURES; POLYGLACTIN 910; POLYPROPYLENES

Outcome Measures

Primary Outcomes (1)

• Short-term infection risk

  Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"

  4 to 21 days

Secondary Outcomes (1)

• Scar appearance

  6 months

Study Arms (2)

Absorbable

EXPERIMENTAL

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

Device: Absorbable

Non Absorbable

ACTIVE COMPARATOR

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

Device: Non absorbable

Interventions

Absorbable 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.

Absorbable

Non absorbable 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

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient younger than 16 years of age with a wound requiring suture

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead

Study Sites (1)

Geneva University Hospital

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries; Wounds, Penetrating

Study Officials

• Giorgio La Scala, MD PD

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD, MD; Attending Surgeon

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)