Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

Completed

• Conditions: Sutures; Tissue Adhesives; Laceration; Child; Wounds and Injuries

• Registration Number: NCT03080467
• Lead Sponsor: University Children's Hospital, Zurich

Brief Summary

This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

Detailed Description

Investigation of the long-term outcome of 300 pediatric patients with traumatic skin lacerations in the head area. After primary wound repair with suture or with tissue adhesive, eligible patients will be enrolled on the emergency department (baseline visit). The second follow-up visit will take place 5-10 days after the baseline visit and the third follow-up visit will be completed 6-12 months after trauma. At both follow-up visits, clinical examination and a brief interview will be performed. Photo documentation is completed at both the baseline and the follow-up visit.

Encrypted photo documentation will be evaluated by blinded external plastic surgeons. Primary Outcome is the cosmetic appearance using standard assessment scales, secondary outcomes are the occurrence of complications, cost-effectiveness and patient's satisfaction.

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-06-13
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

• 0 till16 years of age
• Any primary wound repair treatment of a laceration caused by trauma and involving the skin of the head area
• Patient or caregiver must be able to understand and sign an informed consent

Exclusion Criteria

• Pre-existing conditions that affect wound healing adversely
• Patients who demonstrate severe or life-threatening injuries
• Patients / caregivers with communication / logistic barriers that would make them unfit to provide informed consent or to attend the follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cosmetic scar appearance	second follow-up visit: 6 till 12 months after wound repair	Cosmetic appearance will be assessed using the modified Patient and Observer Scar Measurement Score

Trial Locations

Locations (1)

Children's University Hospital of Zurich; 🇨🇭 Zurich, ZH, Switzerland