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Trial record 3 of 354 for:    NEPTUNE

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

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ClinicalTrials.gov Identifier: NCT02007018
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Last Update Posted Date October 19, 2018
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
Postoperative Surgical Site Infection (SSI) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
  • Need for Home Nursing Care (Home Care) related to Surgical Site Infection (SSI) [ Time Frame: 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.
  • Length of Stay in Hospital [ Time Frame: 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) [ Time Frame: 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.
  • Number of Return Visits Related to Surgical Site Infection [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2013)
Potential Harm from PIMS therapy [ Time Frame: Within the first 30 post-operative days ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
Official Title  ICMJE Negative Pressure Wound Therapy Use to Decrease Surgical Nosocomial Events in Colorectal Resections
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Surgical Site Infections
Intervention  ICMJE
  • Device: Negative Pressure Wound Therapy
    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.
    Other Name: Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)
  • Other: Usual Care of Surgical Wound
    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.
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Device: Negative Pressure Wound Therapy
    • Other: Usual Care of Surgical Wound
  • Active Comparator: Usual Care of Surgical Wound
    This group will receive the usual care of a surgical wound.
    Intervention: Other: Usual Care of Surgical Wound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date March 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02007018
Other Study ID Numbers  ICMJE NEPTUNE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Kinetic Concepts, Inc.
Investigators  ICMJE
Principal Investigator: Michael Ott, MD, MSc, FRCSC, FACS, FASCRS Division of General Surgery, Western University
PRS Account Lawson Health Research Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP