Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Primary Purpose
Wounds and Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Absorbable
Non absorbable
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES
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
Sites / Locations
- Geneva University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Absorbable
Non Absorbable
Arm Description
Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc).
Suture material: Polypropylene thread (Prolene®, Ethicon Inc).
Outcomes
Primary Outcome Measures
Short-term infection risk
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
Secondary Outcome Measures
Scar appearance
Scoring based on the Manchester scar scale
Full Information
NCT ID
NCT02777346
First Posted
May 17, 2016
Last Updated
October 12, 2022
Sponsor
Pediatric Clinical Research Platform
1. Study Identification
Unique Protocol Identification Number
NCT02777346
Brief Title
Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Official Title
Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pediatric Clinical Research Platform
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
WOUNDS, PENETRATING, CHILD, PRESCHOOL, CHILD, INFANT, ADOLESCENT, SUTURES, POLYGLACTIN 910, POLYPROPYLENES
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Absorbable
Arm Type
Experimental
Arm Description
Suture material: Polyglactin 910 thread (Vicryl Rapide®, Ethicon Inc).
Arm Title
Non Absorbable
Arm Type
Active Comparator
Arm Description
Suture material: Polypropylene thread (Prolene®, Ethicon Inc).
Intervention Type
Device
Intervention Name(s)
Absorbable
Intervention Description
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
Intervention Name(s)
Non absorbable
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short-term infection risk
Description
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
Time Frame
4 to 21 days
Secondary Outcome Measure Information:
Title
Scar appearance
Description
Scoring based on the Manchester scar scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio La Scala, MD PD
Phone
+41 22 372 46 63
Email
giorgio.lascala@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Jorgensen, MD
Phone
+41 79 553 97 73
Email
catherine.jorgensen@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio La Scala, MD PD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Study Director
Facility Information:
Facility Name
Geneva University Hospital
City
Geneve
State/Province
Genève
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Jorgensen, MD
Phone
+41 79 553 97 73
Email
catherine.jorgensen@hcuge.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16841785
Citation
McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29.
Results Reference
background
PubMed Identifier
17505281
Citation
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.
Results Reference
result
PubMed Identifier
15231459
Citation
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.
Results Reference
result
PubMed Identifier
18347489
Citation
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.
Results Reference
result
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Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
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