Prophylactic Negative Pressure Wound Therapy to Reduce Surgical Site Infections in Elective Clean-Contaminated Colon Resections
Phase: NA
Conditions: Surgical Wound Infection
Sponsor: Icahn School of Medicine at Mount Sinai



 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
2 
Revised  11/15/2017 
(1,2). The overall SSI rate in elective, clean-contaminated colon resections has been 
reported as high as 25%, the highest SSI rate among all elective surgical procedures 
(1). There has been a national trend in instituting pre-operative and post-operative 
measures to prevent SSIs (colon bundle), which was found to reduce the relative SSI 
rate by over 50% (3). At the Mount Sinai Hospital, the colon bundle protocol includes 
bowel decontamination by mechanical preparation and/or oral antibiotics, monitoring 
and maintenance of a normal perioperative glycemic index, hair clipping outside the 
OR, a preoperative chlorhexidine wash, a wound protector, intravenous antibiotics, a 
separate closing tray, and changing of sterile scrubs prior to closing. The colon 
bundle was first instituted in 2014 at Mount Sinai, and despite these efforts, while the 
overall SSI rate has declined, for high-risk, clean-contaminated cases in patients with 
inflammatory bowel diseases (IBD) or who are undergoing re-operative bowel 
surgery, the SSI rate remains at around 25%. 
Negative pressure incision wound therapy represents a possible opportunity to reduce 
SSIs in colorectal surgery even further. This technology was initially studied in 
orthopedics and later in trauma surgery. In colorectal surgery, a retrospective study 
assessed the use of negative pressure incision wound therapy applied in clean-
contaminated cases, compared to standard of care, and found a greater than 50% 
reduction in the SSI rate (4). However, the intraoperative use of NPWT applied 
immediately following skin closure has not yet been determined in a prospective, 
randomized fashion to reduce SSI in clean-contaminated colon resection cases (5).  
 
Citations: 
1: Fry DE. The prevention of surgical site infection in elective colon surgery. Scientifica 
(Cairo). 2013;2013:896297. Epub 2013 Dec 19. Review. 
2: Shepard J, Ward W, Milstone A, et al. Financial Impact of Surgical Site Infections on 
Hospitals: The Hospital Management Perspective. JAMA 
Surg. 2013;148(10):907-914.  
3: 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.  
4: 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. 
5: 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.  

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
3 
Revised  11/15/2017 
3) Setting of the Human Research 
Informed consent will be obtained in the offices of one of the investigators while the 
patient is in for an office visit or at the Mount Sinai Pre-Surgical Testing Center 
before the patient’s screening visit. No study related tests will be performed prior to 
informed consent. The screening visit and surgery will take place at Mount Sinai 
Medical Center. The follow-up visits will take place at either the Mount Sinai 
Medical Center or at Mount Sinai-affiliated off-site practices. Statistical analyses will 
be performed on de-identified data at Mount Sinai in collaboration with the 
Department of Biostatistics. 
4) Resources Available to Conduct the Human Research 
There are multiple investigators involved in this study in addition to the Principal 
Investigator, Joel J Bauer M.D. The Principal Investigator and Co-Investigators all 
have extensive experience conducting research at the Mount Sinai Medical Center. 
Additionally, a research coordinator is employed and will be involved in the consent 
and data collection processes. Prior to participation, each of the investigators will 
have read the protocol and understand what it involves and what each of their specific 
responsibilities entail. The recruitment goal for this study is about 400 patients in 24 
months. The investigators conduct about 83 clean/contaminated bowel resections 
each month. In order to meet the recruitment goal, between 15 and 20 patients would 
need to be consented each month. Because the vast majority of the study data-points 
are derived from the standard of care perioperative assessments, intraoperative 
clinical documentation, and the standard of care follow-up visits, meeting this 
screening and enrollment goal is feasible.  
5) Study Design 
a) Recruitment Methods 
The research coordinator and the investigators will screen the office schedules of the 
investigators for patients presenting for clean/contaminated colorectal surgeries. A 
HIPAA waiver was submitted to the IRB to allow the study coordinator to access 
names, telephone numbers, and medical record numbers (MRN) to inform an 
investigator of the patient's potential eligibility. Other PHI identifiers have the 
potential to be seen since the pre-screening does involve opening the electronic 
medical records of these patients. However, the study team is only specifically 
looking for elements of PHI that would help them to determine eligibility and be able 
to identify the patient for consenting (name, MRN, date of birth, date of surgery). 
After identifying the possible patient, the investigator will approach the patient about 
the study, to see if the patient is interested. If the patient is interested, the research 
coordinator will then obtain informed consent during the patient’s office visit or prior 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
4 
Revised  11/15/2017 
to a scheduled screening visit. The patient will not be considered enrolled until it is 
determined that they have met all inclusion criteria and do not meet any exclusion 
criteria the day of the procedure.  
 
b) Inclusion and Exclusion Criteria 
All patients from aged 18 or older who will undergo an open or laparoscopic-
assisted clean-contaminated or contaminated colorectal surgical procedure 
will be included if they meet the following criteria. Patients must either have 
an inflammatory bowel disease, undergoing a stoma reversal, undergoing 
reoperation within 30 days, or have two or more of the following risk factors: 
presence of an ostomy, creation of an ostomy, type II diabetes, BMI greater 
than 30, immunosuppression, malnutrition, current smoker, chronic kidney 
disease (creatinine > 1.2), and disseminated cancer. Exclusions include 
patients currently enrolled in another interventional clinical trial, patients with 
a current 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. 
 
c) Number of Subjects 
Up to 400 subjects are expected to be consented at this site. A series of 330 high risk 
patients undergoing elective, open or laparoscopic-assisted, clean contaminated cases 
involving colon resection will be enrolled in this study, of which 110 patients will 
receive an intraoperative application of NPWT and 220 control patients will receive 
the standard of care. This number was chosen based on a power analysis. Assuming 
the NPWT group will have a 50% reduction from the current clean-contaminated 
colon resection SSI rate of approximately 25%, a two-sided, chi-square power 
analysis indicated that with a 2:1, control to experimental ratio, 330 total subjects will 
be needed to detect this difference with 80% power. This number was rounded up to a 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
5 
Revised  11/15/2017 
total of 400 patients expected to be consented in order to account for screen failures, 
changes in operative and post-operative treatments, and subjects lost to follow-up. 
These patients will be allocated to each study arm using a simple randomization 
scheme. Mount Sinai performed almost 1,000 clean-contaminated colon resections in 
2015, and we believe the proposed study can be completed in less than 2 years from 
the first enrollment.  
 
d) Study Timelines 
Subjects will be contacted and consented prior to surgery, and will then be followed 
for up to 37 days after the surgery. It is anticipated that subjects will be enrolled 
through June 2020. The study should be closed out between September 2020 and 
September 2021. An interim analysis will be conducted when approximately 50% of 
the subjects have completed 30 day follow-up (55 treatment; 110 control). This will 
allow the assumptions used to plan the study to be verified or it will allow the planned 
study enrollment to be adjusted. 
e) Study Endpoints 
Primary Outcome: Development of SSI within study follow-up period. 
Secondary Outcomes: Length of hospital stay and serious adverse events. 
 
f) Procedures Involved in the Human Research 
Subjects will be consented prior to each eligible surgery. Prior to surgery, each 
prospective subject will be interviewed by a member of the study team and a medical 
history will be obtained. Randomization will occur prior to the start of surgery. The 
subject will then undergo their scheduled surgery and if they are placed in the 
experimental arm, they will receive the negative pressure wound therapy. If the 
subject is in the control arm, they will receive the standard of care wound dressings. 
Post-operatively, each patient will be followed for up to 37 days and monitored for 
the development of an SSI and secondary outcomes. If there is no evidence of a 
wound infection by post-operative day 5, the NPWT device will be removed. A 
follow-up, outpatient assessment at 30 days (± 7 days) post-operatively will be 
included for all patients who did not develop a SSI. 
 
It is anticipated that approximately 2% or less of subjects enrolled into this study will 
require re-operation of the principal incision for within 5-7 days after the original 
surgery due to various life-threatening complications which may include bleeding, 
anastomotic dehiscence or other septic complications. For subjects requiring re-

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
6 
Revised  11/15/2017 
intervention, who did not develop an SSI prior to the reoperation, the NPWT device 
will be re-applied and the study period re-defined based on the latter procedure. 
 
 
Screening Baseline Day 1 Day 2 Day 3 Day 4
Day 5
Final Visit
≤ 30 days 
preop
23 to 37 days
post op
Study Activity
Informed Consent
X
Enrollment Criteria
X
Demographic/ Clincal 
Information
X
Medical History
X
Inclusion/Exclusion Criteria 
X
Randomization
X
Surgery
X
Application of NPWT Device
X
Bloodwork
X
X*
X*
SSI Assessment
X
X
X
X
X
X
X
AE Monitoring
X
X
X
X
X
X
X
X
Concomitant Medications
X
X
X
X
X
X
X
X
Study schedule of events. * indicates that study event may occur with 24 
hours of study visit. 
g) Specimen Banking 
N/A 
 
h) Data Management and Confidentiality 
All research data for this study will be kept in individual patient research folders, 
which are locked in either a storage office on the 
 
 of 19 East 98thStreet or in 
the locked office of the research manager.  In addition, data will be entered into the 
secure study database which will only be accessible by the research personnel.  All 
patients will only be identified by a unique ID on all study related materials in patient 
research folders and on the database.  The log linking ID numbers to patient identities 
will be kept in a password protected file on a Mount Sinai networked computer.  The 
research manager, research coordinator, and investigators will have access to the file 
containing identifiers.  

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
7 
Revised  11/15/2017 
The data and related publication will be stored according to MSSM’s 
institutional guidelines. The principal investigator will keep the data on a mass 
storage device (example: Mount Sinai’s server) for a minimum period of six 
years after publication. The study investigators will have access to the study 
data, which will be stored on a Mount Sinai secured, shared network drive. 
The de-identified data will be analyzed using statistical software that is 
installed on a secure Mount Sinai computer. Descriptive analysis and 
univariate tests will be performed. Logistic and linear multivariate analyses 
will also be run.  
 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
Part I: Elements of a Data and Safety Monitoring Plan 
1. List the name(s) of the individual(s) at MSSM who will be responsible for data and 
safety monitoring of this study. For each individual, indicate their role, name, title, 
and department information. The Principal Investigator may be the only monitor of a 
study.  
If the qualifications of an individual to serve as a monitor are not contained in the 
PPHS application, they must be added to the DSMP either as a narrative description 
or as a CV. 
 
 
MSSM Principal Monitor: 
Principle Investigator: 
 
First Name: Joel 
Last Name: Bauer 
Academic Title: Clinical Professor 
Department: Surgery 
Mailing Address: 1010 5th Ave.            
New York, NY 10028 
Phone: 646-859-1400 
Fax: 212-650-9981 
E-mail: joel.bauer@mssm.edu 
 
2. Justify your choice of principal monitor in terms of the assessed risk to the research 
subject‘s health and wellbeing. In high risk studies when the principal monitor is 
independent of the study staff, indicate the individual’s credentials, relationship to the 
PI, and the rationale for selection.  Dr. Joel Bauer is the PI of the study and 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
8 
Revised  11/15/2017 
designated principal monitor.  He is a certified, accomplished colorectal surgeon with 
extensive clinical and research experience on colorectal operations and wound 
management. 
3. List the specific items that will be monitored for safety: Adverse events 
4. Indicate the frequency at which ACCUMULATED safety and data information: 
At least annually—more often depending on volume of enrollment.  
6. Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity: This is a phase 3 trial, so dosing ranges to minimize toxicity have already 
been established.  
7. List any specialized grading system that will be used to evaluate adverse events: 
N/A 
8. Describe procedures that will be used to assure data accuracy and completeness: 
Periodic monitoring visits where the monitor will go through collected data, 
confirming with source documents the accuracy and completeness of the data. 
9. Should a temporary or permanent suspension of your study occur, in addition to the 
PPHS, indicate to whom (NIH, FDA, sponsor, IRB) will you report the occurrence: 
IRB. 
 
All serious adverse events (SAEs) will be reported to KCI Inc. within 24 hours of 
learning of the event. SAEs will be reported for the entire duration of the study 
protocol, up to 37 days post operation. 
 
j) Withdrawal of Subjects 
Subjects may voluntarily withdraw from the study at any time without risk that their 
clinical care will be jeopardized in any way.  Subjects wishing to withdraw must do 
so in writing to the principal investigator whose contact information will be provided 
on a copy of the informed consent document that has been signed by the participant 
and given to them to take home.  
6) Risks to Subjects 
1. There is the risk of loss of private health information; this risk always exists, but 
there are procedures in place to minimize the risk. 
 
2. There is the risk of an adverse allergic reaction in patients who are allergic or 
hypersensitive to acrylic adhesives or silver. 
 
3. There is a slight possibility that NPWT device could cause local wound erythema 
and irritation.  
 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
9 
Revised  11/15/2017 
The following AEs are theoretically possible following the application of NPWT 
device. If reported these events should be considered as unexpected:  
(1) Hypersensitivity or inflammatory reaction to surfaces of the device. 
(2) The risks to unborn or nursing (breast-feeding) infants are unknown. The 
NPWT device, although unlikely, may be hazardous to unborn or nursing 
infants. 
7) Provisions for Research Related Injury 
In the event of any personal injury or adverse event resulting from the administration 
of the device, medical expenses for the treatment will be billed to the patient’s 
insurance as per standard of care. There is no compensation available for injury 
resulting from the subject’s personal conduct or participation in activities outside the 
scope of the study protocol.  Financial compensation for such things as lost wages, 
disability or discomfort due to injury is not routinely available. 
8) Potential Benefits to Subjects 
It is possible that subjects who receive the NPWT device will be less likely to 
experience a wound infection postoperatively. 
9) Provisions to Protect the Privacy Interests of Subjects 
Subjects’ privacy will be respected and steps will be taken to put the subject 
as ease in regards to study procedures. The consent processes will take place 
in a private office or exam room. All study procedures will be explained to the 
subject, and any and all questions about the procedures will be answered. 
When subjects are contacted for follow up, the research team will not leave 
voicemails identifying the subject’s participation in this study. Subjects will 
only be approached if they are planning on receiving an open bowel surgery, 
which is one of the main inclusion criteria for this study. PHI will not be 
released, as described in 5h on this form. 
10) 
Economic Impact on Subjects 
The cost of the NPWT device will be paid for by KCI Inc. The expense of any tests, 
or treatments related to standard medical care will be billed to the subject or the 
subject’s insurer in the regular way.   
11) 
Payment to Subjects 
Subjects will not receive any payment from the Mount Sinai or KCI Inc. for 
participating in this study. 
12) 
Consent Process 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
10 
Revised  11/15/2017 
 
Patient consent will be obtained after a full and complete explanation of the 
study. The consent process will take place in the offices of the investigators or 
at the Mount Sinai Pre Surgical Testing Center. Participants will be provided 
with a consent form written in a language they can understand. If English is 
not the primary language of a potential participant, a translated informed 
consent will be provided. Should a translated consent or short form be needed, 
the translated consent document, IRB approved English version of the consent 
document, and a letter attesting to the accuracy of the translation will be 
submitted to the IRB for approval before use of the translated document.   
Patients will be approached with care and will be allowed as much time as 
necessary to review the study. The investigators, clinical team(s), and research 
coordinator(s) will make themselves available for questions or concerns in 
person in the clinic or by phone. Patients will be asked to repeat their 
understanding of the purpose of the research; requirements of participation; 
potential risks, benefits, costs, and alternatives to participation; the voluntary 
nature of participation; and termination of participation. SOP HRP-090 
Informed Consent Process for Research will be followed through the consent 
process. 
The ICF and any other written information provided to patients will be revised 
whenever important new information becomes available that may be relevant 
to the patient’s consent, or there is an amendment to the protocol that 
necessitates a change to the content of the patient information and/or the 
written ICF.  The investigator will inform the patient of changes in a timely 
manner and will ask the patient to confirm his/her participation in the study by 
signing the revised ICF.  Any revised written ICF and written information by 
receive IRB approval in advance of use. 
 
13) 
Process to Document Consent in Writing 
 The informed consent of all subjects will be documented in writing. The standard 
PPHS consent template will be used to obtain informed consent (HRP-502a). 
14) 
Vulnerable Populations 
The following vulnerable populations will be excluded: Adults unable to 
consent, individuals who are not yet adults (e.g. infants, children, teenagers), 
wards of the state (e.g. foster children), pregnant women, prisoners. 
15) 
Multi-Site Human Research (Coordinating Center) 

 
Protocol Title: 
Prophylactic Negative Pressure Wound Therapy to Reduce 
Surgical Site Infections in Elective Clean-Contaminated 
Colon Resections 
Principal Investigator 
Name/Contact Info:  
Joel Bauer, MD 
x42983, joel.bauer@mountsinai.org 
Primary Contact 
Name/Contact Info 
Alex Mui 
x48033, Alex.mui@mountsinai.org 
Date Revised: 
10/10/2018 
Study Number: 
 
 
11 
Revised  11/15/2017 
N/A 
16) 
Community-Based Participatory Research 
N/A 
17) 
Sharing of Results with Subjects 
 
Results will not be shared with subjects. 
18) 
IRB Review History 
N/A 
19) 
Control of Drugs, Biologics, or Devices 
The devices will be stored in a locked office room of the principal investigator at the 
Mount Sinai Hospital, Guggenheim Pavillion 8th floor room 187.