Clinical trial NCT02007018: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Official title: Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Surgical Site Infections
Keywords: Surgical Site Infections
Colorectal Resection
Negative Pressure Wound Therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2013-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative Surgical Site Infection (SSI)
timeFrame: 30 days following operation
Secondary outcomes:
measure: Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)
timeFrame: Up to 60 days post-operatively to encompass the treatment period required for the SSI.
measure: Length of Stay in Hospital
timeFrame: Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
measure: Cost of Management of Surgical Site Infection (SSI)
timeFrame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
measure: Number of Return Visits Related to Surgical Site Infection
timeFrame: Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Other outcomes:
measure: Potential Harm from PIMS therapy
timeFrame: Within the first 30 post-operative days
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Campus
state: Ontario
Study officials:
affiliation: Division of General Surgery, Western University
name: Michael Ott, MD, MSc, FRCSC, FACS, FASCRS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy PB, Knowles S, Chadi SA, Vogt K, Brackstone M, Koughnett JAV, Ott MC. Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE): A Randomized Controlled Trial. Ann Surg. 2019 Jul;270(1):38-42. doi: 10.1097/SLA.0000000000003111.
citation: Chadi SA, Vogt KN, Knowles S, Murphy PB, Van Koughnett JA, Brackstone M, Ott MC. Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial. Trials. 2015 Jul 30;16:322. doi: 10.1186/s13063-015-0817-8.