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临床试验/NCT03000010
NCT03000010已完成不适用

Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis

University of Michigan2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Number of Participants With Wound Dehiscence or Infection

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

详细描述

A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.

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
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • any patient 17 years and younger
  • neuromuscular scoliosis undergoing posterior spinal fusion

排除标准

  • idiopathic and congenital scoliosis
  • any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)
  • intraoperative dural tear
  • documented allergy to adhesive dressings

结局指标

主要结局

Number of Participants With Wound Dehiscence or Infection

时间窗: 2 years

Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

G Ying Li

MD

University of Michigan

研究点 (2)

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