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Prophylactic NPWT to Reduce SSI in Colorectal Surgery

Primary Purpose

Surgical Wound Infection

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prevena

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Negative Pressure Wound Therapy, Colorectal Surgery, Prevena, Surgical Site Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevena

Standard of Care

Arm Description

This group will receive the negative pressure wound therapy device.

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.

Outcomes

Primary Outcome Measures

Incidence of Surgical Site Infection

Any type of Surgical site infection as defined by the CDC developed within the follow-up period.

Secondary Outcome Measures

Length of Hospital Stay

Number of Serious Adverse Events

Number of serious adverse events developed within the follow-up period

Full Information

NCT ID

NCT03661814

First Posted

September 5, 2018

Last Updated

November 19, 2020

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Kinetic Concepts, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03661814

Brief Title

Prophylactic NPWT to Reduce SSI in Colorectal Surgery

Official Title

Prophylactic Negative Pressure Wound Therapy to Reduce Surgical Site Infections in Elective Clean-Contaminated Colon Resections

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Low Enrollment

Study Start Date

August 13, 2018 (Actual)

Primary Completion Date

January 28, 2019 (Actual)

Study Completion Date

January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Kinetic Concepts, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound Infection

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two cohorts. Experimental group receives the study device and the control group receives the standard of care (No device). Patients are randomized to either group.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prevena

Arm Type

Experimental

Arm Description

This group will receive the negative pressure wound therapy device.

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Prevena

Other Intervention Name(s)

Negative pressure wound therapy device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Surgical Site Infection

Description

Any type of Surgical site infection as defined by the CDC developed within the follow-up period.

Time Frame

37 days

Secondary Outcome Measure Information:

Title

Length of Hospital Stay

Time Frame

average of 7 days

Title

Number of Serious Adverse Events

Description

Number of serious adverse events developed within the follow-up period

Time Frame

up to 37 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Bauer, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24455434

Citation

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.

Results Reference

background

PubMed Identifier

23965750

Citation

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.

Results Reference

background

PubMed Identifier

25920911

Citation

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.

Results Reference

background

PubMed Identifier

24201395

Citation

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.

Results Reference

background

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

background

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Prophylactic NPWT to Reduce SSI in Colorectal Surgery

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