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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777346
• Other study ID #: CER 09-057
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Pediatric Clinical Research Platform
• Contact: Giorgio La Scala, MD PD
• Phone: +41 22 372 46 63
• Email: giorgio.lascala[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneve	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Pediatric Clinical Research Platform

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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 — View 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. — View Citation

McCaig LF, Nawar EW. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Adv Data. 2006 Jun 23;(372):1-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term infection risk	Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"	4 to 21 days
Secondary	Scar appearance	Scoring based on the Manchester scar scale	6 months