Child Clinical Trial
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
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.
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.
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