A Randomized Control Trial of Prevena Peel & Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement
Phase: NA
Conditions: Surgical Site Infection, Pancreatic Neoplasms, Pancreatic Cancer, Chemotherapy Effects, Chemoradiation, Surgical Wound, Wound Complication
Sponsor: Johns Hopkins University

 
TITLE: Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical 
Site Infections 
NCT: NCT03021668 
PI: Matthew J. Weiss 
DATE: 04/10/2018 

Date:    April 10, 2018 
Principal Investigator: Matthew J. Weiss 
Application Number: IRB00109564 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 1 of 5 
 
 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
 Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
 When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
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1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Although pancreaticoduodenectomy (PD) outcomes have improved, it remains a procedure 
with a high perioperative complication rate.  Surgical site infection (SSI) is one of the most 
common complications after PD.  In a retrospective review of all patients who underwent PD at 
Johns Hopkins between 9/2011-8/2014, a total of 679 patients, 30-day SSI was observed in 
16.7%. By univariate analysis, perioperative blood transfusion, operative time greater than 7 
hours, pre-operative chemotherapy and/or radiation, bile stent, absence of a superficial wound 
vacuum closure device, and vascular resection were associated with SSI (all, p<0.05).  On 
multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were 
independent predictors of SSI (all, p<0.001). Studies in colorectal patients have found an 
estimated cost of up to $1400 per patient secondary to prolonged hospitalization, wound care, 
and wound complications in patients with procedures complicated by a SSI.  Furthermore, in 
another study of 1144 patients undergoing PD between 1995 and 2011 at Johns Hopkins 
Hospital, post-operative complications delayed time to adjuvant therapy, decreased median 
survival.1 
 
Our hypothesis is that placement of Prevena Peel & Place Dressing using the standard KCI 
VAC after suture on patients undergoing PD at highest risk of infection will result in a 
significant decrease in SSI rate.  We plan to perform a randomized control trial where patients 
who have had pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will 
undergo closure with Prevena Peel & Place Dressing using the standard KCI VAC after suture 
versus standard closure.  We will then follow these patients for 30 days post-operatively to 
determine SSI and other peri-operative complication rate. 
 
2. 
Objectives (include all primary and secondary objectives) 
Primary objective:   
To evaluate the effectiveness of Prevena Peel & Place Dressing using the standard KCI VAC after 
suture closure versus standard closure at reducing wound infections in patients undergoing 
pancreaticoduodenectomy 
 
Secondary objective:   
To evaluate the impact of Prevena Peel & Place Dressing using the standard KCI VAC after suture 
on hospital length of stay, readmission, and time to adjuvant therapy 
 

Date:    April 10, 2018 
Principal Investigator: Matthew J. Weiss 
Application Number: IRB00109564 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 2 of 5 
 
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Although pancreaticoduodenectomy (PD) outcomes have improved, it remains a procedure with a 
high perioperative complication rate.  Surgical site infection (SSI) is one of the most common 
complications after PD.  In a retrospective review of all patients who underwent PD at Johns 
Hopkins between 9/2011-8/2014, a total of 679 patients, 30-day SSI was observed in 16.7%. By 
univariate analysis, perioperative blood transfusion, operative time greater than 7 hours, pre-
operative chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure 
device, and vascular resection were associated with SSI (all, p<0.05).  On multivariable analysis, 
pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of SSI 
(all, p<0.001). Studies in colorectal patients have found an estimated cost of up to $1400 per patient 
secondary to prolonged hospitalization, wound care, and wound complications in patients with 
procedures complicated by a SSI.  Furthermore, in another study of 1144 patients undergoing PD 
between 1995 and 2011 at Johns Hopkins Hospital, post-operative complications delayed time to 
adjuvant therapy, decreased median survival.1 
 
Our hypothesis is that placement of Prevena Peel & Place Dressing using the standard KCI VAC 
after suture on patients undergoing PD at highest risk of infection will result in a significant 
decrease in SSI rate.  We plan to perform a randomized control trial where patients who have had 
pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will undergo closure 
with Prevena Peel & Place Dressing using the standard KCI VAC after suture versus standard 
closure.  We will then follow these patients for 30 days post-operatively to determine SSI and other 
peri-operative complication rate. 
 
Our institution has extensive experience with using this product for the prevention of SSI in patients 
undergoing surgery over the past several years, most specifically after ventral hernia repair.  
Superficial wound vacuum closure has been shown in a previous study by our group to decrease SSI 
from 32% to 9% (p < 0.001) and surgical site occurrence (SSO) from 42% to 17% (p < 0.001) in 
patients undergoing ventral hernia repair.  Furthermore, when used in grade 3 ventral hernias, 
superficial wound vacuum closure had an SSI rate of 5.2% and an SSO of 20.7% at 90 days, which 
is lower than previously published rates using standard closure in these complex hernia repairs.   All 
surgeons who will participate in this study have familiarity with the use of the wound vacuum 
device after surgical closure.   
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
All patients who are planned to undergo pancreaticoduodenectomy at Johns Hopkins Hospital 
will be assessed for eligibility and enrolled. Members of the department of surgery who are 
listed as the team members will be responsible for approaching the participants.  Patients will be 
screened for eligibility. Only patients who have received neoadjuvant therapy and/or have 
undergone biliary stent placement will be approached. In addition patients will also be screened 
for known allergies to silver or acrylic adhesives. 
 
 
 

Date:    April 10, 2018 
Principal Investigator: Matthew J. Weiss 
Application Number: IRB00109564 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 3 of 5 
 
 
Recruitment will take place in the (i) surgical clinics, or (ii) at the pre-operative evaluation 
clinics prior to the surgery. Recruitment process will be mindful of patient privacy issues.  
 
 
Discussions will be held by the potential participant's clinical and will not likely involve any 
additional patient protected health information beyond what is already required for the standard 
medical care. A written consent will be taken from these patients. The patients who are suitable 
candidates for the study will be approached in a clinical setting that is surgical clinics, 
preoperative assessment clinics, etc. 
 
Those members of the research team (principal investigator, co-investigator, research nurse) 
who consent patients have been trained in informed consent procedures, are familiar with the 
protocol, and are listed as a consenter in the application document. Patients are given adequate 
time and privacy to consider the research study. Before the patient signs the consent, the 
consenter must be satisfied that the participant understands the information provided, has had an 
opportunity to discuss the information and ask questions, and is aware that he/she may withdraw 
from the study at any time.  
 
A copy of the signed consent form will be provided to the patients at time of consent. Contact 
information will be provided to these patients so that they can contact the study team in the 
future, if they have any questions regarding the study. 
 
Once consented, these patients will be entered into CRMS. 
 
All consented patients will undergo the same standard PD. At the time of closure the patients 
will be randomized to either standard closure or closure using the Prevena Peel & Place 
Dressing using the standard KCI VAC after suture closure. 
 
The device will be left in place for 4 days after surgery. As part of the patients’ clinical 
evaluation the surgical wound site will be inspected daily by the surgical team. If there are signs 
of infections the device will be removed. All patients will have their device removed prior to 
discharge. 
 
The patients will be evaluated for wound infection during their hospital stay and also during 
their outpatient follow-up for up to 30 days after surgery. The CDC guidelines will be used to 
diagnose SSIs. 
 
  
All patients will be followed for 30 days to collect data on SSI and other post-operative 
complications. 
 
In total we plan to consent 144 patients for this study – 72 patients in the Prevena Peel & Place 
Dressing using the standard KCI VAC after suture closure arm, and 72 patients in the standard 
control arm.  
 
b. Study duration and number of study visits required of research participants. 
The study duration will be approximately 2 years. The patients will not require additional 
research visits. 
 
 

Date:    April 10, 2018 
Principal Investigator: Matthew J. Weiss 
Application Number: IRB00109564 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 4 of 5 
 
 
 
5. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
 
1. Patient to undergo pancreaticoduodenectomy for a pancreatic tumor at the Johns Hopkins 
Hospital 
2. Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior to 
surgical resection, AND/OR placement of a biliary stent and/or drain for biliary tree 
decompression 
 
Exclusion Criteria: 
1. Age 18 years or younger 
3. Laparoscopic or robotic pancreaticoduodenectomy 
4. Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant 
chemotherapy with or without radiation therapy. 
5. All patients who are have known allergies or are sensitive to silver and acrylic adhesives. 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
Our institution has extensive experience with using this product for the prevention of SSI in 
patients undergoing surgery over the past several years, most specifically after ventral hernia 
repair.  Superficial wound vacuum closure has been shown in a previous study by our group to 
decrease SSI from 32% to 9% (p < 0.001) and surgical site occurrence (SSO) from 42% to 17% 
(p < 0.001) in patients undergoing ventral hernia repair.  Furthermore, when used in grade 3 
ventral hernias, superficial wound vacuum closure had an SSI rate of 5.2% and an SSO of 
20.7% at 90 days, which is lower than previously published rates using standard closure in these 
complex hernia repairs.   
 
7. 
Study Statistics 
a. Primary outcome variable. 
The primary outcome variable is surgical site infection (SSI) rate  
     
b. Secondary outcome variables. 
The secondary outcome variables are hospital length of stay, readmission rate, and time to 
adjuvant chemotherapy 
 
c. Statistical plan including sample size justification and interim data analysis. 
The primary outcome variable, SSI rate, will be analyzed using a chi-square test.  The 
secondary outcome variable of hospital length of stay will be analyzed using a t-test if the 
data are normally distributed or a ranksum test if they are not.  The secondary outcome 
variable of readmission rate will be analyzed using a chi-square test.  The secondary 
outcome variable of time to adjuvant chemotherapy will be analyzed using survival analysis 
methods, including Kaplan-Meier curves and log-rank test. 
Prior data from our institution has demonstrated that the risk of a surgical site infection after 
pancreaticoduodenectomy is 30% if the patient either underwent neoadjuvant chemotherapy 
or had a biliary stent/drain placed before surgery.  This study has been powered to show a 
decrease in SSI rate from 30% to 10%, and thus would necessitate 72 patients in each arm of 
the trial (Open Epi software, with Fleiss continuity correction).    
Interim data analysis will only performed to monitor for futility, as described below. 

Date:    April 10, 2018 
Principal Investigator: Matthew J. Weiss 
Application Number: IRB00109564 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 5 of 5 
 
 
d. Early stopping rules. 
 
We will perform an interim analysis when SSI results are available for the first 36 patients in 
each group.  Conditional power calculations will be performed according to the method 
proposed by Proschan, Lan, and Wittes (2006), assuming that the results seen up until the 
interim analysis continue until the end of the trial (empirical conditional power).  If the 
conditional power under the empirical assumption is less than 0.50, the trial will be 
terminated for futility.