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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Absorbable; Device: Non absorbable

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Genève
    • Geneve, Genève, Switzerland, 1205
      • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Absorbable; Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc).	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.
Active Comparator: Non Absorbable; Suture material: Polypropylene thread (Prolene®, Ethicon Inc).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term infection risk	Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"	4 to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar appearance	Scoring based on the Manchester scar scale	6 months

Collaborators and Investigators

• Sponsor: Pediatric Clinical Research Platform
• Investigators: Study Director: Giorgio La Scala, MD PD, University Hospital, Geneva

Publications and helpful links

General Publications

• McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
• Al-Abdullah T, Plint AC, Fergusson D. Absorbable versus nonabsorbable sutures in the management of traumatic lacerations and surgical wounds: a meta-analysis. Pediatr Emerg Care. 2007 May;23(5):339-44. doi: 10.1097/01.pec.0000270167.70615.5a.
• Karounis H, Gouin S, Eisman H, Chalut D, Pelletier H, Williams B. A randomized, controlled trial comparing long-term cosmetic outcomes of traumatic pediatric lacerations repaired with absorbable plain gut versus nonabsorbable nylon sutures. Acad Emerg Med. 2004 Jul;11(7):730-5. doi: 10.1197/j.aem.2003.12.029.
• Luck RP, Flood R, Eyal D, Saludades J, Hayes C, Gaughan J. Cosmetic outcomes of absorbable versus nonabsorbable sutures in pediatric facial lacerations. Pediatr Emerg Care. 2008 Mar;24(3):137-42. doi: 10.1097/PEC.0b013e3181666f87.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): February 6, 2025

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimated): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CHILD; WOUNDS, PENETRATING; CHILD, PRESCHOOL; INFANT; ADOLESCENT; SUTURES; POLYGLACTIN 910; POLYPROPYLENES
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Wounds and Injuries
• Other Study ID Numbers: CER 09-057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO