Wounds and InjuriesNCT02777346
Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
A study testing Absorbable and Non absorbable in people with Wounds and Injuries, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Absorbable and Non absorbable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient younger than 16 years of age with a wound requiring suture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital
Geneva, Canton of Geneva, 1205
About this study
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:
- infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
- 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:
- infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
- scar appearance at a 6-months follow-up.
- Conditions
- Wounds and Injuries
- Being tested
- Absorbable, Non absorbable
- Keywords
- WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES
- Medical subject headings
- Wounds and Injuries, Wounds, Penetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbsorbableDevice
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 absorbableDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Absorbable | Experimental | Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc). Receives: Device: Absorbable |
| Non Absorbable | Active comparator | Suture material: Polypropylene thread (Prolene®, Ethicon Inc). Receives: Device: Non absorbable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term infection risk
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
Measured: 4 to 21 days
Secondary outcomes (1)
Scar appearance
Scoring based on the Manchester scar scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio La Scala, University Hospital, Geneva
- Investigators
- Giorgio La Scala, MD PD, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777346
- Sponsor's protocol ID
- CER 09-057
- Status last verified
- Jul 2025
- First submitted
- 17 May 2016
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
- ClinicalTrials.gov ID
- NCT02777346
- Acronym / sponsor ID
- CER 09-057
- Conditions
- Wounds and Injuries
- Keywords
- WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
- 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:
- infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
- scar appearance at a 6-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable | Experimental | Device: AbsorbableSuture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc). |
| Non Absorbable | Active comparator | Device: Non absorbableSuture material: Polypropylene thread (Prolene®, Ethicon Inc). |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patient younger than 16 years of age with a wound requiring suture
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbsorbableWound 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 | Absorbable |
| Non absorbableWound 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 |
Primary outcome
Short-term infection risk
Time frame: 4 to 21 days
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
1 secondary outcome
Scar appearance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio La Scala, MD PD study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable and Non absorbable in people with Wounds and Injuries, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term infection risk (time frame: 4 to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.