Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT03080467
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive
Sponsor:
University Children's Hospital, Zurich
Organization:
Study Overview
Official Title:
Long-term Outcome of the Primary Wound Repair of Traumatic Skin Lacerations in the Head Area in Pediatric Patients: Suture Versus Tissue Adhesive
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: