跳至主要内容
临床试验/NCT01171534
NCT01171534终止不适用

Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Performance of DermaClose System in Treatment of Fasciotomy Wounds

研究概览

简要总结

Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery.

Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques.

Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.

详细描述

After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients 18 years of age or older
  • •Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome

排除标准

  • •Patient younger than 18 years of age
  • •Patients with an active infection
  • •Patients unable to comply with protocol

研究组 & 干预措施

Vessel Loop fasciotomy closure

Active Comparator

Fasciotomy closure using vessel loops and staples.

干预措施: Vessel loop (Device)

DermaClose fasciotomy closure

Experimental

Fasciotomy closure via DermaClose device

干预措施: DermaClose fasciotomy closure (Device)

结局指标

主要结局

Performance of DermaClose System in Treatment of Fasciotomy Wounds

时间窗: One year

Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation

次要结局

  • Pain(One Year)
  • Quality of Life(One Year)
  • Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure(One year)

研究者

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

Gregory Della Rocca

Associate Professor, Co-Director of Trauma Services, Department of Orthopaedic Surgery

University of Missouri-Columbia

研究点 (1)

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