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临床试验/NCT02883010
NCT02883010撤回不适用

A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery

Smith & Nephew, Inc.0 个研究点开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Number of complications in each group

研究概览

简要总结

Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

PICO

Experimental

Single use NPWT (PICO Softport V1.6)

干预措施: PICO Softport V1.6 (Device)

Standard care

Other

Gauze dressing, Film dressing, foam dressing, skin glue, no dressing

干预措施: Standard Care (Other)

结局指标

主要结局

Number of complications in each group

时间窗: 30 days

次要结局

  • Total number of readmissions during a 30-day follow-up period(30 days)
  • Dehiscence incidence during a 30-day follow-up period(30 days)
  • Total length of hospital stay, including readmissions during a 30-day follow-up period(30 days)
  • Haematoma incidence during a 30-day follow-up period(30 days)
  • Time to surgical incision closure(30 days)
  • Time to initial discharge during a 30-day follow-up period(30 days)
  • To compare PICO against Standard Care for differences in Health Related Quality of Life (HRQoL) using SF-12 over the 14-day and 30-day follow-up period(30 days)
  • Seroma incidence during a 30-day follow-up(30 days)
  • Overall per subject treatment cost for PICO and Standard Care(30 days)
  • Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period(30 days)

研究者

申办方类型
Industry
责任方
Sponsor

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