Prophylactic NPWT to Reduce SSI in Colorectal Surgery

NCT ID: NCT03661814

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2019-01-28

Brief Summary

The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.

Conditions

Surgical Wound Infection

Keywords

Negative Pressure Wound Therapy; Colorectal Surgery; Prevena; Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevena

This group will receive the negative pressure wound therapy device.

Group Type: EXPERIMENTAL

Prevena

Intervention Type: DEVICE

The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.

Standard of Care

This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prevena

The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.

Intervention Type: DEVICE

Other Intervention Names

Negative pressure wound therapy device

Eligibility Criteria

Inclusion Criteria

• ages 18-80
• patients who will undergo an open or laparoscopic-assisted clean/contaminated colorectal surgical procedure.
• Patients must either have an inflammatory bowel disease, undergoing reoperation within 30 days, or have two or more of the following risk factors: presence of an ostomy, type II diabetes, BMI greater than 30, immunosuppression, malnutrition, current smoker, chronic kidney disease (creatinine > 1.2), and disseminated cancer.

Exclusion Criteria

• patients currently enrolled in another interventional clinical trial,
• patients with a BMI less than 20, patients with a current abdominal abscess or infection (including a known urinary tract infection),
• patients allergic to or hypersensitive to silver, patients planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery,
• any patient in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iv) placement of a drain into the intraperitoneal space that emerges through the principal incision; and v) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs,
• patients with healing disorders,
• pregnant women,
• prisoners, or
• any patient that is deemed unsuitable for the study by the Principal Investigator or the operating surgeon/Co-Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

joel bauer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

Fry DE. The prevention of surgical site infection in elective colon surgery. Scientifica (Cairo). 2013;2013:896297. doi: 10.1155/2013/896297. Epub 2013 Dec 19.

Reference Type: BACKGROUND

PMID: 24455434 (View on PubMed)

Shepard J, Ward W, Milstone A, Carlson T, Frederick J, Hadhazy E, Perl T. Financial impact of surgical site infections on hospitals: the hospital management perspective. JAMA Surg. 2013 Oct;148(10):907-14. doi: 10.1001/jamasurg.2013.2246.

Reference Type: BACKGROUND

PMID: 23965750 (View on PubMed)

Tanner J, Padley W, Assadian O, Leaper D, Kiernan M, Edmiston C. Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. Surgery. 2015 Jul;158(1):66-77. doi: 10.1016/j.surg.2015.03.009. Epub 2015 Apr 25.

Reference Type: BACKGROUND

PMID: 25920911 (View on PubMed)

Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013 Dec;56(12):1403-8. doi: 10.1097/DCR.0b013e3182a39959.

Reference Type: BACKGROUND

PMID: 24201395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26223227 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 18-0703

Identifier Type: -

Identifier Source: org_study_id