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Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections (NEPTUNE)

Primary Purpose

Postoperative Surgical Site Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Usual Care of Surgical Wound
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Surgical Site Infections focused on measuring Surgical Site Infections, Colorectal Resection, Negative Pressure Wound Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre - University Campus
  • London Health Sciences Centre - Victoria Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Usual Care of Surgical Wound

Arm Description

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.

This group will receive the usual care of a surgical wound.

Outcomes

Primary Outcome Measures

Postoperative Surgical Site Infection (SSI)
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: Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision 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) Diagnosis of SSI by the surgeon or attending physician

Secondary Outcome Measures

Need for Home Nursing Care (Home Care) related to Surgical Site Infection (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.
Length of Stay in Hospital
Time from surgery to discharge from hospital.
Cost of Management of Surgical Site Infection (SSI)
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.
Number of Return Visits Related to Surgical Site Infection
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

Full Information

First Posted
December 5, 2013
Last Updated
October 17, 2018
Sponsor
Lawson Health Research Institute
Collaborators
Kinetic Concepts, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02007018
Brief Title
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Acronym
NEPTUNE
Official Title
Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
March 6, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Kinetic Concepts, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Surgical Site Infections
Keywords
Surgical Site Infections, Colorectal Resection, Negative Pressure Wound Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care of Surgical Wound
Arm Type
Active Comparator
Arm Description
This group will receive the usual care of a surgical wound.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Other Intervention Name(s)
Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)
Intervention Description
Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI), San Antonio, TX) is an incisional vacuum assisted closure (PIMS) device intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy The PIMS applies continuous pressure to the closed surgical site at 125 mm Hg and is attached to a 45 mL canister for collection of exudate.
Intervention Type
Other
Intervention Name(s)
Usual Care of Surgical Wound
Intervention Description
Patients will receive pre-operative antibiotics consisting of 1g cefazolin (or in the case of an allergy, an alternative e.g. ciprofloxacin/vancomycin) and 500 mg metronidazole given intravenously within the 30 minute prior to beginning the operative procedure. In cases extending > 4 hours, a second dose of each of the antibiotics will be administered. Hair at the operative site will be removed, if required, immediately prior to the skin incision using electric clippers. The abdomen will be prepped using 2% Chlorhexidiene solution (or 10% povidone if allergic). After closure of the skin, the surgical wound will be covered with a sterile adhesive dressing (Tegaderm), which will remain in place until the morning of post-operative day (POD)#2, unless saturated, in which case it is standard practice to change the dressing if the physician is in agreement. On POD#2, the surgical team will remove the initial dressing and daily dressing changes with standard gauze will be initiated.
Primary Outcome Measure Information:
Title
Postoperative Surgical Site Infection (SSI)
Description
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: Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision 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) Diagnosis of SSI by the surgeon or attending physician
Time Frame
30 days following operation
Secondary Outcome Measure Information:
Title
Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI)
Description
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.
Time Frame
Up to 60 days post-operatively to encompass the treatment period required for the SSI.
Title
Length of Stay in Hospital
Description
Time from surgery to discharge from hospital.
Time Frame
Up to 60 days post-operatively to encompass the prolonged stay in hospital of some patients
Title
Cost of Management of Surgical Site Infection (SSI)
Description
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.
Time Frame
Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Title
Number of Return Visits Related to Surgical Site Infection
Description
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
Time Frame
Up to 60 days post-operatively to include the treatment period encompassed in the outpatient setting
Other Pre-specified Outcome Measures:
Title
Potential Harm from PIMS therapy
Description
Allergy/sensitivity or local cutaneous reaction to PIMS or components will be defined as erythema, rash, pruritis, urticaria, contusion, maceration, first degree burn (if device gets too warm) or any other concerning skin changes at the surgical site determined by the primary surgeon NOT to be related to the surgery or a SSI. We will also be looking for unforeseen potential sources of harm that although very unlikely, have never been demonstrated with the use of this device.
Time Frame
Within the first 30 post-operative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ott, MD, MSc, FRCSC, FACS, FASCRS
Organizational Affiliation
Division of General Surgery, Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30499799
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.
Results Reference
derived
PubMed Identifier
26223227
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.
Results Reference
derived

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Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections

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