Clinical trial NCT03661814: 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
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Negative Pressure Wound Therapy
Colorectal Surgery
Prevena
Surgical Site Infection
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2018-09-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of Surgical Site Infection
timeFrame: 37 days
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: average of 7 days
measure: Number of Serious Adverse Events
timeFrame: up to 37 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.