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临床试验/NCT03340025
NCT03340025已完成不适用

Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月15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
20
试验地点
2
主要终点
Progression of Wound Healing

研究概览

简要总结

Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.

详细描述

Many studies have addressed the use of negative pressure wound therapy (NPWT) in free flap donor sites with mixed results. It is well established that NPWT is safe and causes no harm, and no delay in healing. A previous study performed at UAB showed that NPWT in complex Head & Neck Surgery reconstruction is safe, including free flap donor sites. There have been studies that state the rate of tendon exposure is lower with NPWT in free flap donor sites, and studies that conclude there is no difference in complication rates. Current clinical practice is varied, often within a single institution.

While no studies of NPWT in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. Traditional NPWT using canister-based vacuum devices adds significant cost. The PICO single-use NPWT device (Smith & Nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. It is battery-powered and disposable. Empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. We would like to prospectively investigate the use of this low-cost NPWT device and compare it directly to the traditional post-op dressing method.

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

  • > 18 years of age
  • participants are able to consent for themselves
  • undergoing reconstructive surgery requiring split-thickness skin graft coverage of a free flap donor site (i.e., radial forearm free flap or fibula free flap)

排除标准

  • < 18 years of age
  • participants are unable to consent for themselves
  • undergoing reconstructive surgery that does not require split-thickness skin graft coverage of a free flap donor site

结局指标

主要结局

Progression of Wound Healing

时间窗: Baseline through 30 days

Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint.

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

Benjamin Greene

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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