Prophylactic NPWT to Reduce SSI in Colorectal Surgery

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03661814
• Collaborator: Kinetic Concepts, Inc. (Industry)
• Enrollment: 7
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection	Device: Prevena	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Prevention
• Official Title: Prophylactic Negative Pressure Wound Therapy to Reduce Surgical Site Infections in Elective Clean-Contaminated Colon Resections
• Actual Study Start Date: Aug 13, 2018
• Actual Primary Completion Date: Jan 28, 2019
• Actual Study Completion Date: Jan 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prevena This group will receive the negative pressure wound therapy device.	Device: 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.; Other Names: Negative pressure wound therapy device
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Incidence of Surgical Site Infection [37 days]

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

Secondary Outcome Measures

1. Length of Hospital Stay [average of 7 days]

2. Number of Serious Adverse Events [up to 37 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• Kinetic Concepts, Inc.

Investigators

• Principal Investigator: Joel Bauer, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2018

More Information

Publications

• 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.
• 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.
• 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. Review.
• 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.
• 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. Review.

• Responsible Party: joel bauer, Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03661814
• Other Study ID Numbers: GCO 18-0703
• First Posted: Sep 7, 2018
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by joel bauer, Professor, Icahn School of Medicine at Mount Sinai: Negative Pressure Wound Therapy; Colorectal Surgery; Prevena; Surgical Site Infection
• Additional relevant MeSH terms: Infections; Surgical Wound Infection; Wound Infection; Surgical Wound

Study Results

Participant Flow

Recruitment Details	Participants were recruited from August 2018 - December 2018

Arm/Group Title	Prevena	Standard of Care
Arm/Group Description	Prevena: The negative pressure wound therapy (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.	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.
Period Title: Overall Study
STARTED	2	5
COMPLETED	2	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Prevena	Standard of Care	Total
Arm/Group Description	Prevena: The negative pressure wound therapy (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.	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.	Total of all reporting groups
Overall Participants	2	5	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.5 (13.44)	68.4 (8.38)	64.7 (9.996)
Sex: Female, Male (Count of Participants)
Female	2 100%	2 40%	4 57.1%
Male	0 0%	3 60%	3 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	2 100%	5 100%	7 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 20%	1 14.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	2 100%	4 80%	6 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prevena	Standard of Care
Arm/Group Description	Prevena: The negative pressure wound therapy (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.	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.
Measure Participants	2	5
Number [incidences]	2	4

2. Secondary Outcome

Title	Length of Hospital Stay
Time Frame	average of 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prevena	Standard of Care
Arm/Group Description	Prevena: The negative pressure wound therapy (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.	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.
Measure Participants	2	5
Mean (Standard Deviation) [days]	7 (1.00)	7.8 (2.71)

3. Secondary Outcome

Title	Number of Serious Adverse Events
Description	Number of serious adverse events developed within the follow-up period
Time Frame	up to 37 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prevena	Standard of Care
Arm/Group Description	Prevena: The negative pressure wound therapy (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.	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.
Measure Participants	2	5
Number [events]	0	0

Adverse Events

Time Frame	37 days
Arm/Group Title	Prevena		Standard of Care
Arm/Group Description	Prevena: The negative pressure wound therapy (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.		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.
All Cause Mortality
	Prevena		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/5 (0%)
Serious Adverse Events
	Prevena		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Prevena		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.