NCT01135940Unknown2 期
The Use of Dermabond vs. Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery: A Phase II Study
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in the incidence of wound infection in Dermabond group versus the skin staple group
研究概览
简要总结
This is a prospective, Phase II (hypothesis generating) randomized pilot study investigating the efficacy of using Dermabond as a method of final wound closure as compared to the standard staple method in children with Neuromuscular Scoliosis undergoing spinal deformity correction surgery.
详细描述
- To explore whether there is a difference in the incidence of wound infection in the Dermabond group vs. the skin staple group as measured by microbiological culture four days post-operatively. Wound infection is defined as prolonged sterile discharge (>4 days), positive wound cultures, or cellulitis four or more days post-operatively.
- To explore whether there is a difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale. Our hypothesis is that the Dermabond group will have a better cosmetic result. Secondary outcome
- To explore whether there is a difference in the time for final wound closure. Our hypothesis is that the Dermabond group will have a shorter time for final wound closure. Secondary outcome
- To explore whether there is a difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale. Our hypothesis is that parental satisfaction will be higher in the Dermabond group. Secondary outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female 19 years or younger
- •neuromuscular scoliosis
- •undergoing posterior spinal instrumentation and fusion (one stage)
排除标准
- •other non-neuromuscular causes of scoliosis
- •previous history of spinal surgery
- •previous incision over the operative site
- •history of keloid formation
- •allergy to superglue
- •use of anticoagulation therapy
结局指标
主要结局
Difference in the incidence of wound infection in Dermabond group versus the skin staple group
时间窗: 12 weeks after surgery
To explore whether there is a difference in the incidence of wound infection in Dermabond group versus the skin staple group as measured by microbiological culture taken 4 days post-operatively. Wound infection is defined as prolonged sterile discharge , positive wound cultures, or cellulitis four or more days post-operatively.
次要结局
- Difference in mean caregiver/parental satisfaction scores as measured by a visual analog scale(12 weeks after surgery)
- Difference in the cosmetic result of the wound closure as measured by the Hollander wound evaluation scale(12 weeks after surgery)
- Difference in the time for final wound closure(Day of surgery)
研究者
研究点 (2)
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