Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Postoperative Surgical Site Infection (SSI)
研究概览
简要总结
The purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (NPWT) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (SSI) in the first 30 days postoperatively. The investigators hypothesize that the use of NPWT will reduce the rate of postoperative SSI, as well as decrease the need for Nursing Home Care for SSI, length of hospital stay and return visits related to SSI.
详细描述
The proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (NPWT). A prospective randomized open label blind endpoint (PROBE) trial design was chosen. All patients scheduled to undergo elective colorectal resections (CRR) at London Health Sciences Centre (LHSC) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing CRR at their institution. Included patients will be randomized to receive either usual care or usual care plus NPWT. All patients will be followed for 30 post-operative days to identify the development of an SSI and other secondary outcomes. Given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. Outcome assessors and statisticians will be blinded to the patient's allocated group.
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
- 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
- 否
入选标准
- •Age ≥ 18 years
- •Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)
排除标准
- •Palliative colorectal resection where predicted remaining lifespan is likely less than 30 days
- •Abdominoperineal resection or pelvic exenteration
- •Known allergy/sensitivity to adhesive
- •Cases in which there is a suspicion of bowel perforation
- •Pregnancy
研究组 & 干预措施
Negative Pressure Wound Therapy
This group will receive the usual care of surgical wound AND Negative Pressure Wound Therapy (NPWT). The Prevena™ Incision Management System (PIMS) is placed in a sterile fashion over the closed surgical site prior to leaving the operating room. The PIMS is to remain in place until the completion of therapy at five days.
干预措施: Negative Pressure Wound Therapy (Device)
Negative Pressure Wound Therapy
This group will receive the usual care of surgical wound AND Negative Pressure Wound Therapy (NPWT). The Prevena™ Incision Management System (PIMS) is placed in a sterile fashion over the closed surgical site prior to leaving the operating room. The PIMS is to remain in place until the completion of therapy at five days.
干预措施: Usual Care of Surgical Wound (Other)
Usual Care of Surgical Wound
This group will receive the usual care of a surgical wound.
干预措施: Usual Care of Surgical Wound (Other)
结局指标
主要结局
Postoperative Surgical Site Infection (SSI)
时间窗: 30 days following operation
Postoperative surgical site infection (SSI), as defined by the following CDC (Centre for Disease Control) criteria: Infection occurring within the first 30 post-operative days with at least one of the following: 1. Purulent drainage from the incision 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision 3. At least one of the following signs/symptoms of infection * Pain or tenderness * Localized swelling * Redness * Heat AND incision is deliberately opened by a surgeon (unless incision is culture negative) 4. Diagnosis of SSI by the surgeon or attending physician
次要结局
- Length of Stay in Hospital(Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients)
- Cost of Management of Surgical Site Infection (SSI)(Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting)
- Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)(Up to 60 days post-operatively to encompass the treatment period required for the SSI.)
- Number of Return Visits Related to Surgical Site Infection(Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting)