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

NCT02007018 | Completed DMC

• 1 other identifier: NEPTUNE
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Surgical Site Infections

Keywords

Surgical Site Infections; Colorectal Resection; Negative Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

• 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: 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

  30 days following operation

Secondary Outcomes (4)

• 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.

• 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

• 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

Other Outcomes (1)

• Potential Harm from PIMS therapy

  Within the first 30 post-operative days

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

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.

Device: Negative Pressure Wound Therapy; Other: Usual Care of Surgical Wound

Usual Care of Surgical Wound

ACTIVE COMPARATOR

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

Other: Usual Care of Surgical Wound

Interventions

Negative Pressure Wound Therapy DEVICE

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.

Also known as: Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI)

Negative Pressure Wound Therapy

Usual Care of Surgical Wound OTHER

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.

Negative Pressure Wound Therapy; Usual Care of Surgical Wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (2)

London Health Sciences Centre - University Campus

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Centre - Victoria Campus

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• 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.

  PMID: 30499799 DERIVED

• 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.

  PMID: 26223227 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Michael Ott, MD, MSc, FRCSC, FACS, FASCRS

  Division of General Surgery, Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2015
• Primary Completion: March 6, 2017
• Study Completion: September 1, 2017
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)