Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
Phase: NA
Conditions: Wound Infection
Sponsor: State University of New York at Buffalo

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Clinical Protocol 
NCT#02836990 
Revised: August 11, 2017 
 
 
Prevena Incision Management System Versus Dermabond in the Prevention of 
Groin Wound Infections in Patients Undergoing Vascular Surgery 
 
 
 
                                                              
 
                                                                  Principal Investigator: Linda M. Harris, MD 
                                                                                                       Department of Surgery 
                                                                                                       Buffalo General Medical Center 
                                                                                                       (716) 859-4225 
                                                                                                       lharris@kaleidahealth.org 
  
                                                    Sponsor: Acelity 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Protocol Acceptance 
 
 
 
I have read this protocol and agree to adhere to the requirements.  I will provide copies of this 
protocol and all pertinent information to the study personnel. I will discuss this material with 
them and ensure that they are fully informed regarding the conduct of this study, other applicable 
regulations, to applicable laws and the University of Buffalo Health Science Institutional Review 
Board (HSIRB) requirements. 
 
 
______________________________                           _____/_____/_____ 
Principal Investigator Signature                                                    DD       MM      YY 
 
 
 
___________________________________ 
Principal Investigator Printed Name 
 
 
___________________________________ 
Investigational Site 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol Synopsis 
 
 
Prevena versus Dermabond in the Prevention of Groin Wound Infections in Patients 
Undergoing Vascular Surgery 
 
Protocol Number 
 
Test Device 
 
Prevena Incision Management System 
                Primary Objective 
 
 
 
 
To evaluate the clinical efficacy and cost effectiveness 
of Prevena versus Dermabond in preventing groin 
wound infections in patients who undergo vascular  
surgery requiring a groin incision. 
Study Design 
 
 
 
 
A prospective randomized study comparing groin 
wound infection rates and costs of hospitalization for 
Prevena and  Dermabond in patients who undergo 
vascular surgery which requires a groin incision 
Eligibility Criteria 
 
 
 
Adults 18-85 who are scheduled to undergo vascular 
surgery which requires a groin incision who are able to 
consent and are willing to comply with follow-up and 
are or have a responsible individual deemed able to 
take care of a wound.  
Number of Subjects  
140 patients: 70 in each arm of the study 
                Number of Sites 
Buffalo Medical Center, Kaleida Health  
 
Follow-up schedule 
 
 
 
Clinical follow-up will be daily throughout 
hospitalization including day of discharge and within 
30 days of surgery to evaluate healing of the groin 
incision. 
Primary Safety Endpoint 
Major adverse event rate at 30 days defined as: groin 
wound infection 
Primary Effectiveness Endpoint 
30 day healing of the groin wound 
Secondary Effectiveness Endpoint 
 
1. Cost of care including hospitalization and 30 day 
readmission for treatment of a groin wound. 
2. Incidence of antibiotic use upon discharge for 
treatment of infected groin incision 
3. Visiting Nurse home visits and physician office 
visits to assess/treat groin wound infection will also be 
evaluated. 
 
 
 

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Table of Contents 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Introduction 
   1.1 Objective:  
         The purpose of this study is to evaluate the efficacy and cost of Prevena versus Dermabond  
         in the prevention of groin wound infections in patient who undergo vascular surgery which 
         requires groin incision. 
       1.1a Device Name: 
                  Prevena Incision Management System by Acelity 
          1.1b Intended Use: Prevena Incision Management System is a negative pressure wound 
                  therapy device that maintains a closed environment over the surgical incision and 
                  removes exudate through use of negative pressure.  It is intended to be used on 
                  surgical incisions that continue to drain following closure with sutures or staples to  
                  prevent infection and promote healing. 
                    
   1.2 Hypothesis 
         Groin wound infection rates as graded per the Szilagyi score following vascular surgery  
         will be lower in patients treated with the Prevena Incison Management System than in  
         those treated with Dermabond. The cost of using Prevena will be lower than Dermabond 
         due to lower groin wound infection rates, need for subsequent treatment or 30 day hospital  
         readmission for groin wound infection.  
2.0 Background 
 
      The incidence of infection in groin surgical incisions following vascular procedures 
ranges between 3% and 44%,1-8 which is substantially higher than expected rates.9 Groin 
incisions are particularly susceptible to complications such as infection, dehiscence, 
hematomas and lymphatic leaks.7 In part this is due to incision location and body habitus. 
But additionally, use of sutures and staples creates tension points that can produce ischemia 
and potentially cause tissue necrosis.Feinstein 10 Groin wound infections in vascular patients 
can be devastating. Graft infection may occur, particularly when prosthetic material is used, 
limb loss or death may even ensue. At the very minimum, infection contributes to 
significant increases in length of stay and cost. Surgical site infections have been estimated 
to cost an additional $20,000 per admission and increase LOS by 10 days.11 
             The purported benefits of negative pressure systems is the ability to hold incision 
edges together, remove exudate and debris from the site and protect the incision from other 
external infectious sources; attributes which would seem particularly beneficial for groin 
incisions. In addition to the features common to other negative pressure systems, Prevena, 
offers an interface layer of polyester knit fabric that functions similar to a non-adhesive 
dressing and protects the skin from contact with the foam bolster while delivering negative 
pressure and removing fluid. Moreover, Prevena is also noted for ease of use and 
portability.12 

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Prevena’s efficacy has not yet been widely published, particularly in vascular 
patients, but studies which have been completed have been favorable. A small pilot study 
which included only 8 patients demonstrated a benefit to Prevena, however, the study was 
limited due to the comparator arm combining both Dermabond and Primapore dressings. 
13Matatov et al in a larger retrospective review of 90 vascular patients with groin incisions 
documented that infection rates were 5 times lower with Prevena than closure with skin 
adhesive (Dermabond) or absorbant dressing (Primapore) 6% vs. 30%. Costs were lower 
with Prevena because of decreased infection rates and need for subsequent treatment. 14  
Unfortunately, this study is limited by its retrospective design, lack of randomization and 
reporting methods. Infection rates for Dermabond and Primapore were not reported 
separately, yet the efficacy of these two treatment groups could differ substantially.  
 
  
Prevena use has become widespread despite the lack of data from larger 
randomized trials. It would be beneficial to establish its clinical and cost effectiveness in a 
prospective randomized trial.  At our hospital, Prevena is substantially more costly than 
Dermabond (~$495 versus ~$57) but even minimal reductions in infection rates may be 
adequate to offset expense. It is not essential that the cost of Prevena be lower than 
Dermabond to support its use but rather decreased infection rates paired with comparable 
costs will be sufficient to demonstrate its advantage. 
3.0 Inclusion and Exclusion Criteria 
   3.1 Inclusion Criteria 
 Age 18-6 
 In need of elective vascular procedure requiring  > 8cm groin incision 
 Able to provide consent  
 Willing to comply with follow-up 
   3.2 Eligibility screening 
         All referrals to vascular surgeons at Buffalo General Medical Center  
         for the vascular surgery that may 
         potentially require a groin incision will be monitored prospectively by the nurse 
         coordinator through review of operating room schedules, and through communication with 
         surgeons, their scheduling staff and Vascular Surgery residents. Those who meet eligibility 
         requirements will be approached for consent and randomized accordingly. 
3.3 Exclusion Criteria 
 Individuals <18 years of age 
 Adults unable to consent 
 Subjects unable or unwilling to take care of the groin incision, use the Prevena Wound 
Management System or have a designated individual who is capable  
 Subjects with hypersensitivity to adhesives or Silver 
 Prisoners 
3.4 Inclusion of non-English speaking individuals 
 Every effort will be taken to include non-English speaking  individuals 

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4.0 Study-wide Number of Subjects  
4.1 Number of Subjects 
        A total of 140 subjects will be recruited. 
     There will be 70 subjects randomized to each arm.  
 
   5.0 Study-wide recruitment methods 
5.1 and 5.2 Recruitment of Subjects 
     All referrals to vascular surgeons at Buffalo General Hospital for vascular surgery that may    
    require groin incision 
     will be monitored prospectively by the nurse coordinator through review of operating room 
     schedules and through communication with surgeons, their scheduling staff and Vascular  
     Surgery residents. Those who meet eligibility requirements will be approached for consent 
    and randomized accordingly. 
 
5.3 Advertisement 
         Advertisement will not be necessary for the recruitment process. 
 
   6.0 Multi-Site Research Communication  
 6.1 The clinical coordinator will ensure compliance in the following areas and will maintain 
electronic documentation of compliance. 
 The most current version of the protocol, consent document and HIPAA authorization are 
on site and available for review 
 All required approvals have been obtained at each site 
 All modifications have been  IRB approved and communicated to each site prior to 
implementation 
 All data will be secured in a locked cabinet in the coordinators locked office.  Electronic 
data will be stored on a PC in the coordinator’s locked office and will be password 
secured. Patient data will be de-identified at the earliest possible date to prevent possible 
breach in confidentiality. 
 The coordinator will be well versed on the protocol to ensure that investigators conduct 
the study appropriately 
o Noncompliance with the protocol will be reported to the PI at the site and 
remedied appropriately. 
 
7.0 Study Timelines 
7.1 Duration of subject’s participation 
      Subjects will be evaluated throughout hospitalization including the day of discharge, and at 
      at 30 days (25 - 40) following surgery. This will include clinical assessment (Szilagyi 
      Scale) of the groin incision for presence of infection, need/use of antibiotics for groin  

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      incision infection and need for visiting nurse home visits or surgeon office visit prior to 
      scheduled follow-up to treat infection of the groin incision randomized to treatment.    
7.2 Duration of enrollment period 
      The expected enrollment phase is 12 months  
7.3 Projected completion date 
      The anticipated completion date for the study enrollment, follow-up data analysis, report 
      preparation is 05/31/17.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 Figure1.  Study flow Diagram from Subject Screening to Follow-up 
 
 
 
    
 
                                                              ↓ 
                                       
 
                                       ↓ 
                                       
                                          
                                     ↓ 
 
 
                                     ↓ 
 
 
                                     ↓ 
 
 
                                      ↓ 
 
         
 
 
                             ↓ 
 
 
 
 
 
 
Subject in need of vascular surgery requiring a > 8cm groin 
incision is screened for general inclusion/exclusion criteria and 
identified as a potential candidate  
Subject is given explanation of the study, including follow-
up requirements  
Subject signs written informed consent 
Subject is enrolled and randomized 
Surgical procedure is completed. 
Prevena or Dermabond is applied 
per protocol as designated per 
per randomization schedule  
Clinical evaluation of all randomized patients daily 
throughout hospitalization including day of discharge and at  
30 days following surgery  
 
Szilagyi wound assessment of randomized groin 
incision 
 
Use of antibiotics to treat randomized groin incision 
Infection 
 
Need for home care or earlier surgeon  office follow-
up to assess or treat infection of the randomized 
groin incision 

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8.0 Study Endpoints 
8.1 Primary and Secondary Effectiveness Endpoints 
         The primary effectiveness endpoint is 30 day healing of the randomized groin incision, 
with any wound infection or failure to heal during that period representing an endpoint. All 
randomized patients will be followed out to 30 days regardless of developing an infection 
of the randomized groin incision 
         The secondary effectiveness endpoint is total hospital costs including 30 day readmission 
         for treatment of infection of the randomized groin wound. 
               
8.2 Primary Safety Endpoint   
      The primary safety endpoint is a major adverse event rate at 30 days defined as:    
      device malfunction, Grade III Szilagyi Infection or any cause mortality.  
                     Device malfunction-           Any case in which the device does not perform in its  
                                                                 intended function when used in accordance with the 
                                                                 instructions for use.  All device malfunctions will be 
                                                                 reported to the sponsor. Malfunctions that result in an  
                                                                 adverse event must be reported as so. Malfunctions  
                                                                 that do not result in an adverse event do not need to be  
                                                                 recorded as an adverse event as they are not 
                                                                 considered an adverse event. The malfunctioned  
                                                                    device will be returned to Acelity. 
                     All-Cause Mortality-           Death from any cause related or unrelated to surgery, 
                                                                 use of Prevena or Dermabond. Any death will be 
                                                                 reported to the Sponsor as soon as possible A written 
                                                                 report of the death will be provided to the sponsor  
                                                                 within 10 business days and will be provided to the 
                                                                 IRB per guidelines.  If requested, a copy of the death 
                                                                 certificate and autopsy results be sent to the sponsor 
                                                                 when available. Any other source documents related  
                                                                    to the death should also be provided to the sponsor.  
                                                                    If no source documents are available, the PI is 
                                                                    submit a letter to the sponsor describing the  
                                                                 circumstances of the subject’s death. 
                     Groin incision infection      Szilagyi Grade III infection of the randomized groin  
                                                                 incision.                                             
 
 
 
 
 

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9.0  Procedures Involved 
9.1  Study Design 
       This is a prospective multicenter randomized double arm study to evaluate the prevention 
       of groin wound infections in patients undergoing vascular surgery which requires > 8cm 
       groin incision. 
9.11 Randomization Plan:  
       We will employ a 1:1 randomization to either Prevena or Dermabond using a stratified 
        blocked randomization plan with strata determined as a single incision or a bilateral  
        incision with sequences of random block sizes of 4 or 8.  Within the bilateral incision  
        strata, one incision will be randomly chosen relative to defining a single endpoint 
           measure, with site of incision essentially serving as a secondary substratum.         
   9.12 Statistical Analysis Plan Outline: 
           Primary Endpoint 
           The primary endpoint for this trial will be Szilagyi wound infection grade quantified on an 
           ordinal scale (none, grade I: infection contained to the dermus, grade II: infection 
           extending into the subcutaneous tissue but the arterial graft is not involved, grade III: 
           infection of the arterial graft or native vessel underlying the incision).  The primary 
           analysis will be intent to treat and carried forth using an ordinal regression model with a 
           stratified likelihood accounting for the primary randomization strata (incision number) 
           and binary indicator variable for treatment  arm with the primary test of treatment efficacy 
           being the proportional odds different from 1.  In the event of sparse data at the higher  
           grades of infection (<2% at grade III), categories II and III will be combined. For the 
           bilateral incision strata, the primary endpoint will be determined by randomly choosing a 
           single incision as determined within the randomization scheme. 
            Secondary Endpoint  
           The secondary endpoint will be a comparison of cost of treatment between the two arms 
           and will be considered an exploratory analysis. We will utilize regression approaches to 
           account for potential selection bias and censored cost endpoints.   We have completed a 
           preliminary appraisal of the additional per patient hospital costs (dispersed over the entire 
           sample) for treating groin wound infections using the following assumptions.  The 
           associated wound infection rate for Prevena would be 6%.3   Groin wound infections for  
           Prevena and Dermabond would require comparable care.  Although lower wound severity 
           grades have been reported for Prevena3 which could potentially decrease the complexity,  
           duration and cost of  subsequent treatment of wound  infection for this group, the finding  
           was not statistically significant.3 Therefore, we projected that treatment of groin wound 
           infection in both groups  would include an increased 10 day hospital length of stay,1 seven 
           days of IV antibiotics, daily CBC with or without differential and 2 cultures.  We have  
           estimated that the additional per patient cost of treating groin wounds if Prevena were 
           used preemptively ($935- $1,114) would be similar to Dermabond ($869- $1,168) if the 
           incidence of wound infection with Dermabond is < 10%. 

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9.13 Sample size rationale:  
       Given  N=140=70 +70 total subjects and setting the Type I error rate = 0.05, we will have  
       the power of 0.88 to detect a proportional odds of 4.9 different from 1. For our  
       calculations, we assumed a probability vector for the ordinal scale (none, grade I, grade II, 
       grade III) of (0.90, 0.08, 0.019, 0.001) for the  Prevena treatment arm and (0.70, 0.16,  
       0.11, 0.03) for the Dermabond arm respectively. The power estimate was carried forth 
       using10,000 Monte Carl simulations.  This volume should be easily attainable over a 12 
       month period because on average 484 lower extremity revascularizations and 100 
       Abdominal Aortic Aneurysm Repairs are performed annually at Kaleida Health. While 
       most of these procedures (85%) are completed by endovascular approach, access by 
groin cutdown is necessary in 25% of EVAR and 10% of EVI in addition to the planned   
 open lower extremity revascularizations, which should allow for  
         adequate numbers.  SPPS 22 will be used to perform the statistical analysis. 
9.2 Research Procedures  
   Baseline Requirements 
o Informed consent must be obtained from the subject prior to enrollment.  
The following is a list of all assessments and tests that are required during 
the baseline period.  Assessment is based on data available to the 
investigator at time of enrollment. 
 Medical History-  It is required that the subject’s clinical history 
and pre-existing conditions be assessed and documented 
 Physical Exam- It is required that the subject undergo a pertinent 
arterial and venous physical exam and the results be documented 
 Concomitant Medication use- It is required that the subject’s use of 
medications related to the study be provided and documented at 
baseline and throughout follow-up.  Concomitant use includes 
antibiotics, NSAIDs, steroids, aspirin, anticoagulants and 
antiplatelet medications  
 Laboratory Testing- Routine laboratory testing performed prior to 
a surgical procedure will be documented: CBC without 
Differential, Electrolyte Panel 
 Procedure Requirements 
 Concomitant Medication Use 
 Adverse Event (AE) evaluation- any undesirable medical 
occurrences in a subject related or unrelated to the study 
device, study procedure or study requirements that is 
identified or worsens during the clinical study. Adverse 
events must be assessed and documented by the 
investigator at the time of the procedure and at all follow-

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ups (scheduled and unscheduled visits).  All suspected AEs 
must be recorded and reported to the sponsor. See 12.0 
Data Safety Monitoring for definitions of specific AEs  
and AE categorization.  
 Post Procedure Requirements  
 Clinical Status Evaluation :  
o Sizalgyi Infection Score 
 Grade 0- No Infection 
 Grade I- Dermis only 
 Grade II- Subcutaneous tissue involvement 
 Grade III- Arterial Graft Involved 
o Lower extremity vascular assessment 
 Documentation of pulses, color, movement 
 Sensation, Ankle Brachial Index (ABI) 
 Concomitant Medical Use: Prophylactic antibiotics will be 
noted. Use of additional antibiotics along with indication 
will be recorded. Other medications such as NSAIDs, 
steroids, aspirin, anticoagulants and antiplatelet 
medications will also be recorded. 
 AE Evaluation: any infection of the randomized incision or 
other major postoperative morbidity related or unrelated to 
the surgical procedure/ wound treatment which may 
include but is not limited to: MI, CHF, CVA, Respiratory 
distress/failure, renal failure requiring dialysis, re-
intervention for any reason, thrombosis, embolization, 
amputation, blood loss requiring treatment.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table1. Study Assessment Requirements 
Assessment 
Schedule  
(Time-Frame Window) 
Baseline 
<45 days prior 
Labs < 30 days prior  
Procedure 
 
 
Daily While 
Hospitalized 
Day of 
Discharge 
30 Day 
Follow-up 
25-40 Days 
 
Medical History 
X 
 
 
 
 
Physical Exam 
X 
 
 
 
 
Concomitant 
Medication Use 
X 
X 
X 
X 
X 
Laboratory Testing 
X 
 
 
 
 
Clinical Status 
Evaluation 
             With ABI 
X 
 
X 
X 
 
 
X 
 
     X (x1) 
X 
 
X 
X 
 
X 
Adverse Event 
Evaluation 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9.3 Procedures to lessen the probability or magnitude of risks  
 The randomized surgical incision will be irrigated copiously with a solution of 
saline and antibiotics 
 Subjects and caretakers will be educated on the signs and symptoms of 
infection/allergic reaction, use of the Prevena. 
9.4 Device description, purpose and regulatory approval status 
      Prevena Incision Management System by Acelity 
      Prevena is a negative pressure wound therapy device intended for use on surgical incisions 
      that continue to drain following closure with either staples or sutures. Prevena promotes 
      healing by maintaining a closed environment which protects the incision from external 
      infectious sources. Through the application of negative pressure, Prevena removes fluids,  
      and potentially infectious exudate from the surgical site. Prevena is lightweight and 
      portable. 
      Dermabond 
      Dermabond by Ethicon is a cyanoacrylate adhesive that forms bonds across wound edges to 
      promote healing. When Dermabond comes in contact with moisture on the skin surface, it 
      binds to the top epithelial layer and bridges the edges of the incision together, allowing 
      healing to occur  beneath.  It has been marketed to replace sutures < 5.0 in diameter for 
      repair of lacerations or incisions. The multiple benefits of Dermabond include an 
      antimicrobial water resistant coating that protects against external sources of infection,  
      application time is shorter than suture placement, need for suture removal is eliminated  
      and long term cosmetic outcomes are comparable. When Dermabond is used in the 
      extremity or torso, placement of subcutaneous sutures is usually recommended as this tends 
      to improve healing. When used in moist areas of high tension or mobility such as the groin,     
      the incision must be kept dry and mobility restricted. 15   
9.5 Source Records and Data Collection Sheets 
      Source records will include the subjects hospital electronic/paper medical and financial 
      records, surgeons office records and home health care records. 
      Data collection sheets will include patient demographics, co-morbidities, available 
      preoperative vascular testing, operative data, operative, postoperative complications, 
      reintervention, clinical assessment as per table II, antibiotic use and other concomitant 
      medications, hospital LOS, 30 day hospital readmission for infection, total, direct and 
      indirect hospital costs, reimbursement, contribution margin, discharge and 30 day (25-40) 
      clinical assessment (see table II) antibiotic use, use of home health services for wound 
      assessment/care of the randomized incision, or unscheduled office appointments for  
      evaluation or treatment of the randomized incision.       
9.6 Data/Long term Follow-up 
      Patients will be assessed at 30 days (25 -40) following vascular surgery with groin 

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      incision to evaluate healing.  
           
 
 10.0 Data Banking   
 10.1 Data will not be stored for future use 
 
 11.0 Data Management 
 11.1 Data analysis plan and 11.2 Power Analysis 
     Study Design 
     This is a prospective multicenter randomized double arm study to evaluate the prevention 
     of groin wound infections in patients undergoing vascular surgery which requires > 8cm 
     groin incision. 
     Randomization Plan:  
     We will employ a 1:1 randomization to either Prevena or Dermabond using a stratified 
      blocked randomization plan with strata determined as a single incision or a bilateral  
      incision with sequences of random block sizes of 4 or 8.  Within the bilateral incision  
      strata, one incision will be randomly chosen relative to defining a single endpoint 
         measure, with site of incision essentially serving as a secondary substratum.         
        Statistical Analysis Plan Outline: 
        Primary Endpoint 
        The primary endpoint for this trial will be Szilagyi wound infection grade quantified on an 
         ordinal scale (none, grade I, grade II, grade III).  The primary analysis will be intent to 
         treat and carried forth using an ordinal regression model with a stratified likelihood 
         accounting for the primary randomization strata (incision number) and binary indicator 
         variable for treatment  arm with the primary test of treatment efficacy being the 
         proportional odds different from 1.  In the event of sparse data at the higher grades of  
         infection (<2% at grade III), categories II and III will be combined. For the bilateral  
         incision strata, the primary endpoint will be determined by randomly choosing a single 
         incision as determined within the randomization scheme. 
         Secondary Endpoint  
         The secondary endpoint will be a comparison of cost of treatment between the two arms 
         and will be considered an exploratory analysis. We will utilize regression approaches to 
         account for potential selection bias and censored cost endpoints.   We have completed a 
         preliminary appraisal of the additional per patient hospital costs (dispersed over the entire 
         sample) for treating groin wound infections using the following assumptions.  The 
         associated wound infection rate for Prevena would be 6%.3   Groin wound infections for  
         Prevena and Dermabond would require comparable care.  Although lower wound severity 
         grades have been reported for Prevena3 which could potentially decrease the complexity,  
         duration and cost of  subsequent treatment of wound  infection for this group, the finding  
         was not statistically significant.3 Therefore, we projected that treatment of groin wound 

17 
 
         infection in both groups  would include an increased 10 day hospital length of stay,1 seven 
         days of IV antibiotics, daily CBC with or without differential and 2 cultures.  We have  
          estimated that the additional per patient cost of treating groin wounds if Prevena were 
          used preemptively ($935- $1,114) would be similar to Dermabond ($869- $1,168) if the 
          incidence of wound infection with Dermabond is < 10%. 
      Sample size rationale:  
       Given  N=140=70 +70 total subjects and setting the Type I error rate = 0.05, we will have  
       the power of 0.88 to detect a proportional odds of 4.9 different from 1. For our  
       calculations, we assumed a probability vector for the ordinal scale (none, grade I, grade II, 
       grade III) of (0.90, 0.08, 0.019, 0.001) for the  Prevena treatment arm and (0.70, 0.16,  
       0.11, 0.03) for the Dermabond arm respectively. The power estimate was carried forth 
       using10,000 Monte Carl simulations.  This volume should be easily attainable over a 12 
       month period because on average 484 lower extremity revascularizations and 100 
       Abdominal Aortic Aneurysm Repairs are performed annually at Kaleida Health. While 
       most of these procedures (85%) are completed by endovascular approach, access by 
groin cutdown is necessary in 25% of EVAR and 10% of EVI, which should allow for  
         adequate numbers.  SPPS 22 will be used to perform the statistical analysis. 
11.3 Securing the Data 
        The data will be collected by a single nurse coordinator with vascular surgery experience, 
         who has received training  on the case report forms developed for use in this study. The 
         coordinator will also be trained to enter information from the case report form into 
         a database set up in SPSS on a password protected PC kept in a locked office. All protected   
         health information on the database will be de-identified. Subjects will be assigned a study  
         number at time of randomization.  The case report forms which contain patient identified 
         protected health information will be kept in a locked cabinet within the coordinator’s 
         locked office. These will be retained for the required 3 year period following the study and 
         the disposed of per institutional HIPPA policy.  A master list of the patient name, DOB, 
hospital medical record number and study number to allow accurate linking of follow-up 
         data to the index case will also be kept in a locked cabinet in the locked coordinator’s 
         office.     
        11.4  Quality Control of Collected Data – 11.11 Handling and Transmission of Data 
         All appropriate sections of the case report form (CRF): (See appendix ) will be completed  
         by the coordinator, viewed and signed by the prinicipal investigator  and entered into the 
         database within two weeks following the subject’s discharge for the index procedure. The 
         follow-up forms will be completed within a timely fashion after follow-up. 
         Study monitors designated by the sponsor will review the information documented in the 
         CRF to verify that the recorded information is consistent with the medical record or other 
         source documents and that input of this information into the data base is accurate. Errors or 
         incomplete data will be rectified.  All information will be treated as confidential. The 
         following individuals will have full access to the data: Principal investigator, clinical 

18 
 
         coordinator, statistician Co-investigators, vascular technicians, Core Lab personnel and 
         study monitors will have access on an as needed basis. 
 
 
 
        
 
 
        
 
        
        
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
             
 

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Table 2. Adverse Event Definitions and Categorizations 
Adverse Event 
Any undesirable medical occurrences in 
a subject whether or not it is related to 
the study device, procedure or study 
requirements that is identified or worsens 
during the clinical study 
 
Major Adverse Event 
A primary safety endpoint  adverse event 
defined as Sizlagyi Grade III infection of 
the randomized incision and all-cause 
mortality 
Grade III Szilagyi infection 
of the randomized incision 
All-cause mortality  
 
Serious Adverse Event 
Any adverse event that results in death, is 
life threatening, requires > 24 hour in-
patient hospitalization, or prolongation of 
an existing hospitalization, requires 
intervention to prevent permanent 
impairment/damage or results in 
persistent or significant 
disability/incapacity  
Myocardial Infarction 
Congestive Heart Failure 
Pulmonary Embolus 
Respiratory Failure 
Stroke  
Cardio/Pulmonary Arrest 
Thirty day hospital 
readmission for Grade II or 
III Szilagyi infection of the 
randomized incision 
Unanticipated Adverse Event 
Any serious adverse event leading to 
injury, illness or death of a subject not 
previously identified in nature, severity 
or degree of incidence in this protocol, 
literature or application (including a 
supplementary  plan or application) that 
may be directly related to use of the 
device 
 
 
    
   Table 3.  Procedure Related Categories for Adverse Events 
Procedure Related Adverse Event 
AE that have a strong temporal relationship 
to the procedure and an alternative  
etiology is unlikely 
Probably Procedure Related Adverse Event 
AE that have a strong temporal relationship 
to the procedure and an alternative etiology 
is less likely than the potential relationship 
to the procedure 
Probably–Not Procedure Related Adverse Event 
AE that have minimal or no temporal 
relationship to the procedure and/or a more 
than likely alternative etiology 
Not Procedure –Related Adverse Event 
AE is due to the underlying disease state or 
concomitant medication or therapy and not 
caused by the procedure 
Criteria for MAE and SAE 

20 
 
Serious Infection-                Grade III Sizlagyi infection of the randomized incision 
Myocardial Infarction-        Per the ESC/ACC definition for acute, evolving or recent MI 
                                            Typical rise and gradual fall of Troponin or more rapid rise and fall 
                                             of (CK-MB) biomarkers or myocardial necrosis with at least one of  
                                            the following: 
 Ischemic symptoms 
 Development of pathologic Q weave on ECG 
 ECG changes indicative of ischemia (ST segment elevation 
or depression) or coronary artery intervention ( ie: coronary 
angioplasty 
 Pathologic findings of an acute MI 
Congestive Heart Failure-   New or worsening shortness of breath confirmed by chest x-ray 
                                             findings consistent with CHF and/or requiring unscheduled dialysis 
                                             or fluid restriction  
Cerebrovascular Accident- A neurologic deficit lasting more than 24 hours, or lasting less than 
                                           24 hours with a brain imaging study showing infarction.                       
Pulmonary Embolus-          Embolus in the pulmonary vascular documented by CT findings 
Respiratory Failure-            Respiratory difficult requiring intubation  
Cardio-Pulmonary Arrest-  Loss of pulse and respiration. Need for cardio-pulmonary 
                                            resuscitation to prevent impending death         
    
Interim analysis will be performed of the primary and secondary endpoints after half of the 
subjects are enrolled and again when all subjects are enrolled.  Anova will be used to determine 
differences in infection rates between the two treatment arms.  The PI will verbally communicate 
the findings to Acelity with recommendations to continue, stop the study or make changes to the 
protocol if additional patients are needed to achieve statistical significance. These will be 
provided in writing within 4 weeks.  
 
13.0 Withdrawal of Subjects      
13.1 Circumstances under which subjects would be withdrawn without their consent 
        All study subjects have the right to withdraw their consent at any time during the study. 
        However, withdrawal of a subject from the study can occur at the direction of the PI or the 
        sponsor. Reasons for physician directed withdrawal could include but are not limited to: the  
        subject’s not adhering to the study follow-up protocol, the subject enrolls in another study  
        which conflicts with this study’s primary or secondary endpoints, or if the physician deems 
        it is in the patients best interest for safety or welfare of the subject to withdraw. 
13.2 Procedures for Termination 
        When possible the coordinator should obtain written documentation from the subject that 
        wishes to withdraw his/her consent for future follow-up and contacts.  If written 
        documentation is unable to be obtained, all information regarding the subject’s withdrawal 

21 
 
        must be recorded in the subject’s medical record.  In addition, the appropriate CRF’s must 
        be completed for the subject and clear documentation of the subject’s withdrawal be 
        provided to the sponsor. 
13.3 Procedures for partial withdrawal 
        Subject withdrawal is unlikely because other than randomization to intra-operative wound 
        treatment, all care will be provided in the standard fashion and follow-up requirements (30 
        day follow-up with the surgeon or his/her designee) will be the same regardless of  
        participation in the study. However, if the subject for any reason chooses to withdrawal 
       from the study, procedure will be followed as in 13.2.      
13.4 Lost to Follow-up 
        Every attempt will be made to have all subjects complete the follow-up schedule. A subject 
        will not be considered lost to follow-up unless efforts to obtain compliance are 
        unsuccessful.  At minimum, three attempts by telephone via the most recent contact number 
        should be made. If these efforts are unsuccessful, a certified letter from the PI should be 
        sent to the subject’s last known address.  Attempts to contact the subject should be noted in 
        the his/her medical record and on the study case report form. 
 
14.0 Risks to Subjects  
14.1 Foreseeable risks 
        Subjects in this study will be exposed to anesthetic, operative, and postoperative risks 
        inherent to vascular surgery that requires groin incision.  
 Anesthetic risk 
                   Anesthesia will be provided per the surgeon’s preference and will not expose  
subjects to additional risk beyond that experienced during routine vascular surgery. 
 Procedural risks 
Additional procedural risks will be nominal.  
 Postoperative Risks 
                    Routine postoperative care will be provided and will pose no additional risk to 
                    subjects in either arm of the study. 
 Follow-up Risks  
Standard intervals for follow-up will be employed and will pose no additional risk 
for subjects in either arm of the study     
o Clinical evaluation will be required at 30 days (25 -40) after surgery 
 
14.2 Unforeseeable risks  
        Any serious adverse event leading to injury, illness or death of a subject not previously  
        identified in nature, severity or degree of incidence in this protocol, literature or application  
        (including a supplementary plan or application) that may be directly related to use of the  
        device  
 

22 
 
15.0 Potential Benefits to Subjects 
15.1 Potential benefits may be experienced in subjects randomized to:  
        Prevena Incision Management System 
        Patients randomized to Prevena may have lower rates of groin incision infection and 
        and be less likely to require additional wound care treatment or longer hospital length of  
        stay, or readmission to the hospital within 30days to manage infection. Need for home 
        health care to manage wound infection may be lower and recuperation period shorter than if 
        infection was to occur.  
15.2 Potential benefits to hospital  
        Premptive use of Prevena may lower surgical incision infection rates and 30 day 
        readmission rates for treatment of infected surgical incisions, key outcomes 
        measures by which hospitals are evaluated.  The associated reduction in surgical site 
        infection rates may result in decreased spending, thus improving hospital contribution 
        margin. 
 
16.0 Vulnerable populations 
16.1 Safeguards to protect the rights and welfare of vulnerable populations 
        Minors, pregnant women, prisoners or cognitively impaired adults will not be included in 
        the study. 
 
17.0 Community-Based Participatory Research 
17.1 Community involvement in the design and conduct of the Study 
        The concept and design of the study was developed by the Principal Investigator in 
        collaboration with members of the research team including co-investigators, study 
        coordinators and a biostatistician. This project has the potential to change current 
        standards of practice for surgical wound management in subjects who undergo vascular 
        surgery that requires a groin incision. To the individual, this translates to a  
        hospitalization less likely to be complicated by infection which equates to quicker 
        recovery and positive hospital experience. Image is critical to hospitals in this competitive 
        health care market as are quality outcomes such as low surgical infection rates and reduced 
        hospital readmission. Both are likely to be associated with substantial financial savings and 
        improved utilization of resources. 
 
         
 
18.0 Sharing of Results with Subjects 
18.1 Individual results of the clinical endpoint will be obvious to the subject and will be shared 
        via verbal communication from the surgeon or his designee (resident, nurse 
        practitioner, physician assistant).  Results will be shared with the subject’s primary care 
        physician through written correspondence. Results of the study when available will be 

23 
 
        shared verbally with the subject upon request. 
19.0 Setting 
19.1 Description of study site locations 
       The study will be conducted at 2 sites: Buffalo General Medical Center, Kaleida Health, and 
       Erie County Medical Center (ECMC).  The Veteran’s Administration Medical Center of  
       Buffalo (VAMC) may be added with an addendum if there is a need for additional numbers.   
       This would require a separate IRB submission.  
 The Buffalo General Medical Center is a___ bed University of Buffalo Medical 
School affiliated Tertiary Care Center. The Medical center boasts a new state of the 
art Global Vascular Institute and is a key provider of vascular care to Western New 
Yorkers. Over _____ vascular procedures are completed annually by five board- 
certified vascular surgeons, including 2 academic surgeons and the Division Chief of 
the Division of Vascular Surgery, Department of Surgery, University of Buffalo 
Medical School, and an internationally known vascular surgeon, trained 
internationally. The medical center is the premiere training site for the University’s 
Vascular Fellowship and Integrated Vascular Residency Programs accredited 
through the Accreditation Council of Graduate Medical Education. 
19.2 Identification of potential study subjects  
        The nurse coordinator will identify potential study subjects through multiple- sources. 
 The coordinator will monitor the office schedules of participating surgeons and 
identify patients having vascular surgery that requires groin incision as potential 
candidates. 
 The office staff of participating surgeons will be asked to notify the 
coordinator when scheduling a patient office visits for lower extremity  
intervention or aortic aneurysm repair likely to require a groin incision 
 The coordinator will review the operating room schedule daily to identify potential 
subjects 
 The coordinator will collaborate daily with the Vascular Fellow/resident to identify 
potential candidates on the Vascular Service or referred to the Vascular Service for 
surgery that may require groin incision.  
o Vascular Fellows/residents will be asked to notify the coordinator of  
 potential study subjects 
19.3 Location of Research procedures 
        Research procedures will be completed in the following areas 
 Surgeon’s exam room, patient hospital room or other private room in the hospital 
Patients may be screened for eligibility, consent obtained and randomized to a study 
arm in the surgeon’s office, patient hospital room or other private room in the 
hospital. 
 Operating Room 

24 
 
o Prevena (3 units) and Dermabond are both readily available in the OR 
supply area.  The coordinator will ensure that there continues to be an 
adequate supply to allow for randomization. Both products are also 
used for other procedures, both vascular and other surgical 
interventions.  
 The Clinical coordinator’s office, participating surgeon’s office, medical record 
department, hospital surgical unit 
These areas may be used for collecting and in-putting data. 
 
The aforementioned precautions will be used to assure patient confidentiality 
19.4 Community Advisory Board 
         There will be no community advisory board 
19.5 Research conducted outside of the organization and its affiliates 
         This study will not involve any research outside of the designated participating sites. 
 
20.0 Resources Available 
20.1 Qualifications of staff: 
        Lead Principal Investigator:  Linda M. Harris, MD FACS, Division Chief: Division of 
                                                      Vascular Surgery, University of Buffalo Medical School.                                   
        Co-Investigator:                    Maciej L. Dryjski, MD, PhD, FACS, Director 
                                                      
        Sub-Investigators:                 Gregory S. Cherr, MD, FACS: Attending Vascular Surgeon 
                                                       Buffalo General Medical Center   
                                                       James Lukan, MD, FACS: Director AV Access Center, ECMC 
                                                       Raphael Blochle, MD: Attending Vascular Surgeon, ECMC   
                                                       G Richard Curl, MD 
 
 
 
 
       Sonya Noor, MD 
 
 
 
 
       Ivan Dominguez, MD 
 
        Study Consultant                   Monica S. O’Brien-Irr, MS, RN; Vascular Research NP   
        Protocol, Case Form              Department of Surgery                                    
        Data Base Development 
        Statistical Assistance 
 
        Biostatistician:                       Alan Hutson, PhD, Founding and Current Chairman;   
                                                       Department of Biostatistics, School of Public Health and 
                                                       Health Related Professions; University of Buffalo 
 
        Study Coordinator:                A medical health professional with experience in coordinating  
                                                       the daily operations of clinical research trials and oversight of  
                                                       research assistants will be assigned                                                      

25 
 
                                                        
        Research Assistant:               A medical health professional with experience in assisting the 
                                                       clinical coordinator  with daily operations of clinical trial will  
                                                       be assigned 
                                                       
20.2 Feasibility of recruiting subjects 
        One hundred and forty subjects will be enrolled in this study: seventy in each arm. 
        Recruitment should be achievable over a 12 month period because on average 484 lower 
        extremity revascularizations and 100 abdominal aortic aneurysm repairs are performed  
        annually at Buffalo General Medical Center.  While most of these procedures are completed 
        by endovascular approach (EVAR, EVI), access by groin cut-down is necessary in  25% of 
        EVAR and 10% of EVI which would provide approximately 204 potential candidates,  
        nearly a third more subjects than necessary to meet study enrollment requirements. 
20.3 Time necessary to conduct the research project 
        The projected completion time for the study is 18-24 months allowing a minimum 
        recruitment period of 12 months with an additional 6-9 months if necessary and 
        3-6 months for data analysis, write-up and study closure. 
        Anticipated Personnel time requirements  
 1/4 FTE Study Consultant for development of protocol and case report forms,  
                             statistical analysis, preparation of manuscript and slide presentation 
 1/2 FTE clinical coordinator for project oversight 
 1 FTE research assistant for start-up, patient screening, data collection , 
     entering of data and maintenance of the data base, study closure  
 10-20 hours Bio-statistical consultation   
 
20.4 Facilities 
        Please refer to 19.1 
20.5 Availability of medical or psychological resources for study subjects. 
        It is anticipated that psychological counseling will be not be required due to subject 
        participation in the study since additional psychological risk associated with study  
        involvement should be none or minimal. 
        The surgeon performing the vascular surgery will be available to subjects for evaluation and 
        treatment of any surgical or postoperative complication that may arise from the procedure,  
        or  during the follow-up period. 
20.6 The sponsor or a representative of the sponsor will conduct a training session with each  
        Principal investigator and his/her staff to review the protocol, instructions for use of the  
        Prevena  Incision Management System, case report forms (CRFs), the informed  
        consent process, IRB/EC involvement and guidelines, responsibilities  and obligations,  
reporting requirements and general guidelines for good clinical practice. 
 

26 
 
21.0 Prior Approvals    
21.1 Prior to enrolling subjects at the investigational site, the following documents will be  
           provided to the sponsor: 
 IRB/EC approval for the Clinical Protocol 
 IRB/EC approval for the Principal Investigator to conduct the study 
 IRB/EC and sponsor approved Consent Form for the study 
 Investigators Curriculum Vitae (CV) 
 Financial Disclosures of the Principal Investigators and sub-investigators 
 Signed Investigator Agreement and if applicable, Sub-Investigaors 
Agreements 
 Training log documenting each participating surgeon has been trained on the   
Prevena Incision Management System. 
   Training log documentation to verify that appropriate study staff have been 
  trained on the protocol, system, CRFs and study conduct. 
22.0 Recruitment Methods 
22.1- 22.4 Details of Patient Recruitment 
        The nurse coordinator will identify potential study subjects through multiple- sources. 
 The coordinator will monitor the office schedules of participating surgeons and 
   identify patients referred for lower extremity revascularization or AAA repair 
   as potential candidates. 
 The office staff of participating surgeons will be asked to notify the 
coordinator when scheduling  patient office visits or surgery for lower 
extremity revascularization or AAA repair 
 The coordinator will review the operating room schedule daily to identify 
potential subjects 
 The coordinator will collaborate daily with the Vascular Fellow/resident to        
identify potential candidates on the Vascular Service or referred to the Vascular 
Service for lower extremity revascularization or AAA repair.  
o Vascular fellows/residents will be asked to notify the coordinator of  
 potential study subjects 
22.5 Payments to Subjects 
    Subjects will not receive monetary compensation for this study. 
23.1 Local Accrual of Subjects 
   All subjects will be accrued locally 
23.2 Screen Failures 
    Screen failure will not be an issue with subject recruitment as there are few exclusion 
    criteria for this study. The most likely reason for nonparticipation would be patient  
    refusal.  All screen failures will be noted on a log with the reason documented 
       
24.0 Confidentiality 

27 
 
24.1 - 24.5 Procedures to assure maintenance of confidentiality, storage, access and  
                  transmission of data  
        The data will be collected by a single nurse coordinator with vascular surgery 
         experience, who has received training  on the case report forms developed for use in this  
         study. The coordinator will also be trained to enter information from the case report form 
         into a database set up in SPSS on a password protected PC kept in a locked office. All 
         protected health information on the database will be de-identified. Subjects will be  
         assigned a study number at time of randomization.  The case report forms which contain  
         patient identified protected health information will be kept in a locked cabinet within the 
         coordinator’s locked office. A master list of the patient name, DOB, hospital medical 
         record number and study number to allow accurate linking of follow-up data to the index 
         case will also be kept in a locked cabinet in the locked coordinator’s office. Only 
         personnel listed in the study protocol will have access to the data which will be restricted  
         to an as needed basis. The subjects’ CRF will be retained for the required 3 year period  
         following the study and the disposed of per institutional  HIPPA policy. 
 
25.0 Provisions to Protect the Privacy Interests of Subjects 
25.1 Steps to protect subject’s privacy interest  
   At time of recruitment, potential subjects will be made aware of the need for  
   study personnel to review their medical record, surgeon office record, vascular laboratory  
   results for pertinent medical information following enrollment in the study through   
   30 days (25-40) following surgery but the review will be restricted to an as needed basis. 
   Subjects will be informed of efforts to maintain confidentiality of protected health  
   information.  Only subjects who are agreeable to these terms will be enrolled.  If during 
   the study period, the subject wishes to restrict interaction with a particular study member  
   or limit that individual’s access to his/her protected health information and the situation 
   can not be resolved, the subject should submit a written request to the PI. This will be 
   noted in the subject’s medical record and be included in his/her  CRF. Every reasonable 
   effort will be made to comply with the subjects request.  If this is not feasible, the 
        subject will be withdrawn from the study and missing data will be censored. 
25.2 Assuring the Subjects Ease 
    Study enrollment is unlikely to cause any greater patient uneasiness beyond that which 
    would be naturally experienced when an individual requires lower extremity 
    revascularization or repair of AAA.  Documentation of the patients pertinent past medical 
    history would be the same regardless of study enrollment as would preoperative testing and 
    physical examination. The study will be explained in understandable terms.  The subject 
    will be assured that participation is voluntary and decision not to participate will not in any 
    way impact his/her care. The subject will be treated respectfully at all times and given  
    ample opportunity to ask questions.  Study personnel will assure that all questions are 
    adequately answered prior to enrollment. 

28 
 
25.3  The research team will be permitted to access any source of information on a subject  
    (ie. medical record, hospital financial record, surgeon office record, vascular laboratory 
        results) on an as needed basis. 
 
26.0  Research Related Injury: Compensation 
26.1  This research poses only minimal risk to patients beyond that associated with routine lower  
         extremity revascularization or AAA repair.  Both Prevena and Dermabond are currently 
         being used in vascular patients with groin incisions. Allergic reaction which is uncommon  
         for either Prevena or Dermabond could be a potential risk.  We will limit this through 
         thorough screening of allergies to adhesives, formaldehyde, cyancoacetate and silver prior  
         to enrollment. If the subject does incur a research related injury, care related to that injury 
        will be provided, but there will be no additional compensation, as both are commercially   
        available, and FDA approved for the planned procedures.  
 
27.0 Economic Burden to Patient 
27.1 Subjects will incur no additional expense as a result of participation in the study.  
    Hospitalization and first postoperative follow-up will be covered by the 
    subject’s insurer. 
 
28.0 Consent Process 
28.1- 28.20 
    Informed consent will be obtained from all subjects prior to enrollment by one of the 
    following study personnel: coordinator, participating surgeon, co-investigator or PI.  
    SOP: Informed Consent Process for Research (HRP-090) will be used.  The subject 
    may be consented in the surgeon’s office, patient hospital room or another private room  
    within the hospital. Consent will be obtained after the subject has been provided 
    information concerning the study and has had all questions satisfactorily answered.  
    Subjects who are uncertain regarding participation will be given additional 
    time to deliberate.  The study coordinator will contact the individual within three 
    days to ascertain the subject’s decision. Non-English speaking individuals will be 
         recruited. The likely language would be Spanish, due to the Hispanic population in 
        Western New York. A certified Spanish speaking hospital interpreter will be used to  
    provide information on the study and assist in obtaining informed consent. The consent 
    form and other written materials  will be provided in Spanish. Minors, cognitively impaired  
         adults, prisoners and adults unable to give consent will not be included in the study. 
           
29.0 Process to document Consent in Writing 
29.1 Consent Process 
    SOP: Written Documentation of Consent (HRP -091) will be used to document consent. 
 

29 
 
30.0  Drugs and Devices 
30.1 Storage and Handling of study device 
    The Prevena Incision Management System and Dermabond will be stored in the 
    Operating Room. All participating surgeons will be trained on the system and study 
protocol. 
30.2  IND/IDE/Abbreviated IDE 
    The Prevena Incision Management system received FDA approval for  
        Use.  Additional FDA approval is not required for this study 
     
31.0  Protocol Amendments 
31.1  Procedure for amending the protocol 
    This protocol is to be followed exactly and will only be altered by written amendments.  
    Administrative changes that do not affect the patient benefit/risk ratio (ie: editorial  
    changes for clarity) may be made without further approvals.  Any change that would 
    require alteration in the Informed Consent form must receive approval from Acetily 
    and the IRB at the respective study sites prior to implementation. Following approval, the  
    protocol amendments will be distributed to all protocol recipients with instructions to  
   amend the protocol.  
 
 
 
 
 
32.0 Definitions 
        Adverse Event Definitions 
Adverse Event 
Any undesirable medical occurrences in a subject whether 
or not it is related to the study device, procedure or study 
requirements that is identified or worsens during the 
clinical study 
Major Adverse Event 
A primary safety endpoint  adverse event defined as 
thrombosis of the AV fistula, fistula re-intervention and 
all-cause mortality 
Serious Adverse Event 
Any adverse event that results in death, is life threatening, 
requires > 24 hour in-patient hospitalization, or 
prolongation of an existing hospitalization, requires 
intervention to prevent permanent impairment/damage or 
results in persistent or significant disability/incapacity  
Unanticipated Adverse Event 
Any serious adverse event leading to injury, illness or 
death of a subject not previously identified in nature, 
severity or degree of incidence in this protocol, literature 
or application (including a supplementary  plan or 
application) that may be directly related to use of the 
device 

30 
 
 
       
Allergic Reaction:  Allergic reaction which could result in nausea, rash, wheezing, 
edema induced thrombotic events, urticarial or shock. 
 
Aneurysm:  A localized, pathologic, blood filled dilation of a blood vessel caused by 
weakening in the vessel wall. 
 
Artery Perforation: Extravasation of a small quantity of blood outside the arterial 
adventitial layer. 
 
Artery Rupture: Large transmural disruption of a vessel with gross extravasation and  
            hemorrhage. 
 
 
 
As-Treated Analysis: An “As Treated” analysis is one in which all participants in a 
            study are analyzed according to the treatment received , regardless of the initial 
            assignment and regardless of the amount of follow-up. 
 
 
Bleeding:  Blood loss resulting from surgery that may require 
            transfusion of blood products. 
 
            
            Cardio-Pulmonary Arrest:  Loss of pulse and respiration.  Need for cardio-pulmonary 
            resuscitation  to prevent impending death       
 
 
Concomitant Medication: Medication use related to the study, including antibiotics  
            aspirin, NSAIDs, steroids. 
 
 
Congestive Heart Failure: 
 
 
Acute: New or worsening shortness of breath confirmed by chest x-ray 
                        findings consistent with CHF and/or requiring unscheduled dialysis 
                        or fluid restriction. 
 
 
Established or History of CHF: New York State Heart Failure Classification 
                         
Class 
Description 
Class I 
No physical limitations and is Asymptomatic 
Class II 
Mild symptoms while doing light exercise or activities of daily living 
Class III 
Difficulty doing simple activities of daily living 
Class IV 
Frequently bed or chair ridden for most of the day and is too weak and 
short of breath to do simple activities 
 

31 
 
 
Death: Termination of Life 
 
 
Device Malfunction:  Defined as a malfunction in the Prevena Incision Management 
            System such that it did not perform its intended function when used in accordance with  
            the Instructions for Use. 
           
 
Device-Relatedness Categories of Adverse Events:      
Device Related Adverse Event 
AE that have a strong temporal relationship to the 
presence or performance of the device/system and 
an alternative etiology is highly unlikely 
Probably Device Related Adverse 
Event 
AE that have a strong temporal relationship to the 
presence or performance of the device/system and 
an alternative etiology is less likely than the 
potential relationship to the device/system 
Probably–Not Device Related 
Adverse Event 
AE that have minimal or no temporal relationship 
to the presence or performance of the 
device/system and/or a more than likely 
alternative etiology exists 
Not Procedure –Related Adverse 
Event 
AE is due to the underlying disease state or 
concomitant medication or therapy and not caused 
by the device/system 
 
Device Success:  Ability to deploy the Prevena Incision Management System as intended 
at the treatment site. 
 
Diabetes (History of):  Defined as subjects who have been diagnosed with either Type I 
or Type II diabetes and are currently diet controlled, taking oral hypoglycemic or insulin. 
 
Discharge:  The time-point in which the subject is released from the admitting hospital, 
transferred to another facility or expired. 
 
Dissection:  Intimal disruption of the vessel wall. 
 
 
Embolus/Embolization: Obstruction of a blood vessel by a foreign substance (air,  
            plaque debris or blood clot). 
 
 
Emergent Surgical Revascularization:  Surgery performed on an urgent or emergent 
            basis. 
 
 
Enrollment:  The subject is enrolled after he/she has signed the informed consent and 
            has been determined to meet all the inclusion criteria and no exclusion criteria.   
 

32 
 
 
Fever:  An increase in internal body temperature to levels above normal: 
            (37○ C or 98.6○ F). 
 
 
Hematoma:  Localized mass of extravasated blood. 
 
 
Hemorrhage:  Bleeding requiring hospitalization, repeat procedure, operation or  
            Transfusion. 
 
 
 
Hypertension:  Increase in the systolic blood pressure over 140 mm Hg or a diastolic  
            blood pressure above 90 mm Hg. 
 
 
 
Hypotension:  Fall in systolic blood pressure that requires treatment with vasopressors,  
            inotropic agents or fluid resuscitation. 
 
 
Infection:  Caused by bacterial or viral sources and produces an immunologic response 
            resulting in inflammation, redness, swelling heat, pain or dysfunction of the organ 
            involved and elevation of the white blood count. Infection in this study will be classified  
            according to Szilagyi wound grade: 0= No signs of infection,  I=  Infection limited to the  
           dermis,  II=  Infection involving the subcutaneous tissue, but not the arterial graft,  
            III=  Infection which involves the arterial graft. 
                    
 
 
 
Intention-to-treat Analysis:  An intention to treat analysis is one in which the data from 
            all participants in the study are analyzed according to the allocated treatment regardless  
            of the treatment received. 
 
Myocardial Infarction (MI):  Per the ESC/ACC definition   
                   Acute, evolving or recent MI 
                                            Typical rise and gradual fall of Troponin or more rapid rise and fall 
                                             of (CK-MB) biomarkers or myocardial necrosis with at least one of  
                                            the following: 
 Ischemic symptoms 
 Development of pathologic Q weave on ECG 
 ECG changes indicative of ischemia (ST segment elevation 
or depression) or coronary artery intervention ( ie: coronary 
angioplasty 
 Pathologic findings of an acute MI 
 
Established MI or History of MI 

33 
 
 
 
         Pathologic findings of a healed or healing MI 
 
      
            Physician directed subject withdrawal: Withdrawal of the subject from the study at the 
           direction of the principle investigator. Reasons for physician directed subject withdrawal 
           include but are not limited to: the subject not adhering to the study protocol requirements,  
            the subject enrolls in another study that conflicts with this study’s primary endpoints, or  
            if the PI deems it is in the best interest  for safety and welfare of the subject to withdraw. 
            
           Principal Investigator:  Physician responsible for the overall clinical management of 
            subjects enrolled at his/her institution.  Assumes responsibility and accountability for the 
            clinical team and for data obtained from each subject participating in the study.  Assures 
            compliance with the protocol, applicable laws and applicable regulations; ensure 
            informed consents are signed  and reviews an signs case report forms indicating that 
            documents are accurate and complete. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Procedure-Relatedness Categories for Adverse Events: 
 
Procedure Related Categories for Adverse Events 
Procedure Related Adverse Event 
AE that have a strong temporal relationship to 
the procedure and an alternative  etiology is 
unlikely 
Probably Procedure Related Adverse 
Event 
AE that have a strong temporal relationship to 
the procedure and an alternative etiology is less 
likely than the potential relationship to the 
procedure 
Probably–Not Procedure Related 
AE that have minimal or no temporal 

34 
 
Adverse Event 
relationship to the procedure and/or a more 
than likely alternative etiology 
Not Procedure –Related Adverse 
Event 
AE is due to the underlying disease state or 
concomitant medication or therapy and not 
caused by the procedure 
 
            Protocol Deviation: Any divergence from the study protocol. 
 
 
Pulmonary Embolus: Embolus in the pulmonary vascular documented by CT findings. 
 
 
Reintervention: Any surgery or radiologic intervention on the index procedure. 
 
            Respiratory Failure:  Respiratory difficult requiring intubation  
 
 
Sepsis: Systemic inflammatory response to infection. 
 
Shock:  A condition in which the cells of the body receive inadequate amounts of oxygen 
            to changes in perfusion most commonly secondary to blood loss or sepsis. 
 
 
Stroke: A neurologic deficit lasting more than 24 hours, or lasting less than 24 hours  
            with a brain imaging study showing infarction. 
 
 
 
Study Coordinator:   Employee at investigational site that assists the PI with study 
            activities as delegated by the PI, including tracking subjects involved in the study,  
            scheduling tests and follow-up visits, maintaining study records, completing and  
            providing the CRF to the sponsor in a timely fashion. 
 
Sub-Investigators:  Physicians responsible for the study activities in coordination with  
the PI and in accordance with the protocol.  A site is not required to have a co- 
investigator. 
 
Thrombosis: Formation or development of blood clots that lead to occlusion of the 
artery or bypass graft  
 
Transient Ischemic Attack:  A neurologic deficit that lasts < 24 hours and if an imaging 
study is performed, there is no evidence of infarction. 
 
            
 
            
 

35 
 
            
 
            
 
             
      
 
 
             
 
             
            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix A: Contacts 
 
Sponsor:  
Acelity  
 
 
Principal Investigator (PI):                                           
Linda M. Harris, MD                                                       
Department of Surgery B7 
Buffalo General Medical Center 

36 
 
100 High Street 
Buffalo, NY 
(716) 859-4225 
lharris@kaleidahealth.org 
 
Co-Investigator:                                
Maciej L. Dryjski, MD, PhD                       
Department of Surgery B7  
Buffalo General Medical Center 
100 High Street 
Buffalo, NY 
(716)859-4518 
mdryjski@kaleidahealth.org  
      
 Sub-Investigator (SI):                                                                                             
 Gregory S. Cherr, MD                                                         
 Department of Surgery B7 
 Buffalo General Medical Center 
 100 High Street 
 Buffalo, NY 
 (716)859-2453 
 gcherr@kaleidahealth.org 
 
Biostatistician 
Alan Hutson, PhD,  
Department of Biostatistics, School of Public Health and 
Health Related Professions; University of Buffalo 
Kimball Tower 
Main Street  
Buffalo, NY 
ahutson@buffalo.edu 
 
Study Consultant 
Monica S. O’Brien-Irr, MS, RN    (Vascular Research) 
Department of Surgery B7 
Buffalo General Medical Center 
100 High Street 
Buffalo, NY 
(716)859-4229 
mobrien@kaleidahealth.org 

37 
 
 
Study Coordinators: 
Lynn Feng 
Meriem Said 
 
 
  
         
 
         
 
        
 
 
 
 
         
 
         
         
         
         
 
 
  
 
 
 
Appendex B: References 
 
 
1.   Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ. Wound complications at the 
      groin after peripheral arterial surgery sparing the lymphatic tissue: a double blind randomized 
  clinical trial.  Am J Surg 2009;197:747-51. 
 
2.    Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infra- 
       inguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect 
       (Larchmt) 2000;1:257-63. 
 
3.   Lawlor K, DeRose G, Harris KA, Lovell MB, Novick TV, Forbes TL. The role of platelet- 

38 
 
      rich plasma in inguinal wound healing in vascular surgery patients. Vasc EndoVasc Surg 
      2011;45:241-5.     
 
4.   Exton RJ, Galland RB. Major groin complications following the use of synthetic grafts. Eur J 
      Vasc Endovasc Surg 2007;34:188-90. 
 
5.   Engin C, Posacioglu H, Ayik G, Apaydin Az. Management of vascular infection in the groin. 
      Tex Heart Inst J 2005;32:529-34. 
 
6.   Bandyk DF. Vascular surgical site infection: risk factors and preventative measures. Semin 
      Vasc Surg 2008;21:119-23. 
 
7.   Swinnen J, Chao A, Tiwari A, Crozier J, Vicaretti M, Fletcher J. Vertical or transverse  
      incisions for access to the femoral artery: a randomized control study. Ann Vasc Surg 
      2010;24:336-41. 
 
8.   Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of  
      early (<30 day) vascular infection using vacuum-assisted closure alone without muscle flap 
      coverage in a consecutive patient series. J Vasc Surg 2010;51:1160-6. 
 
9.   Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of 
      surgical site infection. ICHE J 1999;1999(20):251-9. 
 
10.  Easterlin B, Bromberg W, Linscott J. A novel technique of vacuum-assisted wound closure 
       that functions as a delayed primary closure. Wounds 2007;19:331-3. 
 
11. De Lissovoy G, Fraeman K, Hutchins V….   Surgical site infection: incidence and impact on 
      hospital utilization and treatment cost. Am J Infect Control 2009;37:387-97. 
12.  Prevena TM Incision Management System  
      @ http://www.woundsource.com/product/prevena- incision-management -system.  
 
13.  Weir G…. The use of a surgical incision management system on vascular surgery incisions: 
       a pilot study. International Wound Journal 2014;11Supp1:10-2 
 
14.  Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative 
       pressure incision management system in prevention of groin wound infection in vascular  
      surgery patients. J Vasc Surg 2013;57:791-95. 
 
15.  Bruns TB and Worthington JM. Using tissue adhesive for wound repair; a practical guide to 
       Dermabond. American Family Physician 2000;61:1383-88. 

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Appendix C: Consent Form 
 
 
 
 
 
 
 
 
 

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