Long-term Outcome of the Primary Wound Repair of Traumatic Skin Lacerations in the Head Area in Pediatric Patients: Suture Versus Tissue Adhesive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Cosmetic scar appearance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cosmetic scar appearance
时间窗: 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
次要结局
未报告次要终点