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CompletedNCT02777346Updated Jul 4, 2025

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

An interventional study of Absorbable and Non absorbable in Wounds and Injuries, sponsored by Pediatric Clinical Research Platform. Completed at 1 site in Switzerland. Open to participants aged 1 Day to 16 Years. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by Pediatric Clinical Research Platform · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
1 Day to 16 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Wounds and Injuries

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Keywords

  • WOUNDS, PENETRATING
  • CHILD, PRESCHOOL
  • CHILD
  • INFANT
  • ADOLESCENT
  • SUTURES
  • POLYGLACTIN 910
  • POLYPROPYLENES
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 550 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Pediatric Clinical Research Platform is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
550 participants (actual)

Study arms

  • Experimental
    Absorbable

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

    Device: Absorbable

  • Active comparator
    Non Absorbable

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

    Device: Non absorbable

Interventions

  • DeviceAbsorbable

    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.

  • DeviceNon 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.

06

What researchers measure

Primary outcomes

  1. Short-term infection risk

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

    Time frame: 4 to 21 days

Secondary outcomes

  1. Scar appearance

    Scoring based on the Manchester scar scale

    Time frame: 6 months

07

Study locations

1 site
  • Geneva University Hospital
    Geneva, Canton of Geneva 1205, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02777346
Lead sponsor
Pediatric Clinical Research Platform
Responsible party
Giorgio La Scala (PD, MD; Attending Surgeon, University Hospital, Geneva) — Principal investigator
First posted
May 19, 2016
Start date
May 2016
Primary completion
Feb 6, 2025
Completion
Feb 6, 2025
Last update
Jul 4, 2025

Study contacts

Giorgio La Scala, MD PD
study director · University Hospital, Geneva

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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