A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PICO
Single use NPWT (PICO Softport V1.6)
干预措施: PICO Softport V1.6 (Device)
Standard care
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)
