Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
- Conditions
- Postoperative Surgical Site Infections
- Interventions
- Device: Negative Pressure Wound TherapyOther: Usual Care of Surgical Wound
- Registration Number
- NCT02007018
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Age ≥ 18 years
- Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Negative Pressure Wound Therapy 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. Negative Pressure Wound Therapy Usual Care of Surgical Wound 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. Usual Care of Surgical Wound Usual Care of Surgical Wound This group will receive the usual care of a surgical wound.
- Primary Outcome Measures
Name Time Method Postoperative Surgical Site Infection (SSI) 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
- Secondary Outcome Measures
Name Time Method Length of Stay in Hospital Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients Time from surgery to discharge from hospital.
Cost of Management of Surgical Site Infection (SSI) Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting The cost of each SSI will be determined using the hospital case-costing dataset for inpatient care, clinic visits, and emergency department visits, and the standardized time and materials costs available from the Community Care Access Centre for home care.
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. The need for home care will be determined by the surgical team after the identification of an SSI, and will be recorded by the study team. The duration of home care requirements will be determined at the time of post-operative clinic visits, as the home care process requires ongoing written communication with the surgeon for the duration of therapy, and this communication is concurrently occurring at the time of clinic visits.
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 A return visit related to SSI will include any visit to the emergency department, outpatient surgical clinic, or requirement for admission to hospital that is deemed by the primary surgeon or study team to be due to a) signs or symptoms of SSI requiring assessment; b) development of an SSI requiring management; or c) ongoing care of a known SSI
Trial Locations
- Locations (2)
London Health Sciences Centre - University Campus
🇨🇦London, Ontario, Canada
London Health Sciences Centre - Victoria Campus
🇨🇦London, Ontario, Canada