跳至主要内容
临床试验/NCT01366105
NCT01366105撤回不适用

Use of Negative Pressure Wound Therapy for At Risk Surgical Closures

Georgetown University2 个研究点 分布在 1 个国家开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incisional Dehiscence

研究概览

简要总结

In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.

All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.

详细描述

No further description is desired

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients presenting to wound center undergoing wound treatment with expected closure of wounds including: Midfoot amputations, below knee amputations, knee disarticulations, above knee amputations, and trunk wounds
  • wounds must be closed primarily without the use of grafts

排除标准

  • any patient <18 years old
  • any patient whose wound is unable to be closed primarily

结局指标

主要结局

Incisional Dehiscence

时间窗: last post operative visit, up to 2 years

any amount of incisional dehiscence noted post-operatively

Post operative infection

时间窗: last post operative visit, up to 2 years

Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage)

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

Christopher Attinger, M.D.

Chief of the Division of the Center for Wound Healing

Georgetown University

研究点 (2)

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