Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Phase: NA
Conditions: Of Bypass Graft of the Extremities, Peripheral Arterial Disease, Vascular Diseases, Cardiovascular Diseases
Sponsor: Boston Medical Center

1 
 
Protocol for 
 
PICO-LEB: Standard Versus PICO Dressings in 
Lower-Extremity Bypass Patients 
 
Date: March 26, 2015 
Version 2 
NCT02492854 
 
 
 
 
Statistical Analytic Plan (Section 8, pages 13-14)  
 
H-33618  
PI- Jeffrey Siracuse, MD  
617-638-8488  
Email:Jeffrey.Siracuse@bmc.org 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
Trial Summary 
 
The objective of this study is to compare the effectiveness of standard dressings and 
PICO single-use negative pressure dressings in post-operative lower extremity bypass 
patients. This study will compare the dressings’ ability to decrease swelling, decrease 
post-operative infection, and improve mobility and quality of life measures. 
  
Subjects will be asked to participate in this study because they will undergo a lower 
extremity bypass using the ipsilateral great saphenous vein. Subjects will then be 
randomized to two post-operative treatment groups. One group will receive standard 
sterile gauze and the other will receive PICO single-use negative pressure dressings. Both 
groups will be assessed for study measures in follow-up clinical visits up to 30 days. 
 
 

3 
 
Trial Overview 
 
 
 
 

4 
 
Schedule of Activities 
 
 
Post 
Procedure 
 
Base-
line 
Immed. 
Post-op 
2 Days  
7 
(±3) 
14 
(±3) 
30 
(±3) 
Q3-6 
mo. 
Informed consent 
X 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
Physical examination and 
medications 
X 
 
 
 
 
 
 
Focused peripheral  
vascular history 
X 
 
 
 
 
 
 
In-person clinical 
evaluation (physical 
examination; update 
medical/vascular history 
and medications) 
X 
 
 
X 
X 
X 
X 
Assessment symptoms 
X 
 
 
X 
X 
X 
X 
Pain scale 
X 
 
 
X 
X 
X 
X 
Renal function 
X 
 
 
X 
X 
X 
X 
Vital Status 
X 
 
 
X 
X 
X 
X 
Quality of Life 
(VascuQoL, SF-12, 
EuroQoL EQ-5D) 
X 
X 
 
X 
X 
X 
X 
Les swelling % measured 
X 
X 
X 
X 
X 
X 
X 
Remove moist dressing 
(standard wound care 
only) 
 
 
X 
 
 
 
 
Remove PICO dressing 
 
 
 
X 
 
 
 
Additional dressings as 
needed 
 
 
 
X 
X 
X 
X 
Adverse Events 
 
Throughout the trial 
 
 
 

5 
 
1. Introduction 
 
1.1 Background 
Post-operative infection after lower extremity bypass operations (LEB) can lead to 
devastating consequences. A systematic review of lower-extremity (LE) re-
vascularization cases using the American College of Surgeons National Surgical Quality 
Improvement Program (ACS-NSQIP) found that 11.1% of patients were diagnosed with 
surgical site infections (SSI). [1] Another arterial reconstruction LE randomized control 
trial (RCT) of 500 patients found a general wound complication incidence rate of 30%, 
the majority of which were superficial SSIs. [2] Lower extremity bypass (LEB) specific 
reviews have reported wound complications in as high as 44% of surgical sites (femoral 
popliteal/tibial and pedal bypasses). [3,4] Another main issue in LEB is swelling, which 
occurs in about 70% of these patients and leads to increased pressure along the leading 
edges of often-long wounds. A wide variety of methods to decrease these post-operative 
consequences are currently part of standard practice. These techniques include covering 
incision sites with sterile gauze dressing, elevating the leg, and wrapping with pressure 
dressings. Patients are then instructed to change dressings themselves at home. However, 
SSI rates demonstrate that these are only partially effective measures, and there remains 
room to improve post-operative management of infection and swelling. 
 
Negative pressure wound therapy (NPWT), over the past several years, has provided a 
way to post-operatively manage complex wounds. This is a therapy with potential to 
decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative 
pressure wound therapy provides a sealed, moist environment and shuttles fluid away 
from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 
mmHg) and exudate is suctioned and collected in a control unit. We would like to 
investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing 
which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, 
both of which allow for ease of use. PICO has been FDA-approved. 
 
Case series have been completed to evaluate the efficacy and feasibility of use in 
orthopedic inpatient and outpatient, community, and vascular surgical wound 
management [5,6,7,8]. RCT surgical studies have also been performed to compare 
standard dressings and PICO in caesarean section and elective Crohn’s disease and 
surgery, both reporting a decrease in post-operative wound complications [9,10]. A 
systematic review of RCTS comparing standard dressings and NPWT in ulcer 
management and traumatic surgeries found that NPWT is at least as effective, and in 
cases more effective than gauze dressings. The greatest effectiveness was found in 
chronic leg and post-traumatic ulcers [11]. However, there remains a lack of evidence on 
the effectiveness of NPWT in vascular surgery via high-quality randomized control trials. 
This study aims to bridge that gap. 
 
1.2 Rationale and hypothesis  
Lower extremity bypass, a major open vascular surgery, is associated with significant 
post-operative swelling and infection. This indicates that current therapies, e.g. 
compression stockings and sterile dressings, are limited in their effectiveness. PICO 

6 
 
single-use negative pressure dressings have been examined in previous studies. However, 
these were either case series, for chronic wounds, or for non-vascular procedures. The 
effectiveness of PICO versus standard dressings in LEB has yet to be determined in a 
prospective, comparative study. Results will indicate whether PICO should be included 
standard post-operative care of lower-extremity bypass patients. This study is designed to 
compare PICO and standard care, and determine which offers the best outcomes of 
decreased days to ambulation and post-operative wound complications. 
 
The study hypothesis is that participants using PICO dressings will demonstrate superior 
post-operative recovery measures, have reduce leg edema and possibly reduce post-
operative surgical site infections.  
 
 
2. Objectives 
These include swelling, infection, and resumption of activities of daily living. Secondary 
objectives are to (1) compare functional status after 1 year of follow-up and (2) to 
compare resource utilization associated with treatment of patients randomized to either 
group. 
 
 
3. Trial design 
This design is a prospective, randomized, two-arm single-center trial comparing the 
effective of moist gauze dressings to PICO single-use negative pressure dressings. 
 
 
4. Study population 
4.1  Inclusion criteria  
Each patient must meet all of the following inclusion criteria to be enrolled in the study. 
• Age > 35 years old 
• Patient to undergo lower extremity bypass using ipsilateral great saphenous vein 
harvest 
• Patient willing to comply with protocol, attend follow-up appointments, complete 
all study assessments, and provide written informed consent 
 
4.2  Exclusion criteria  
• Patients meeting any of the following exclusion criteria are not to be enrolled in 
the study. 
• Life expectancy of less than 2 years 
• Any infrainguinal revascularization procedure on index leg within 12 weeks prior 
to treatment 
• Current immune-suppressive medication, chemotherapy, or radiation therapy 
• Pregnancy or lactation 
• Inability or refusal to provide informed consent 
• Patients who received an investigational drug for peripheral arterial disease within 
4 weeks of screening or who participated in another non-observational clinical 
trial in the prior 30 days 

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• Prior leg bypass on the ipsilateral limb 
 
4.3  Protected populations 
• Prisoners 
• Due to the complexity of state and federal requirements governing the 
participation of prisoners in research, patients who are prisoners will not be 
considered for participation in this trial.  
• Pregnancy 
• Patients who are known to be pregnant will be excluded from participation. A 
negative urine pregnancy test is required for all women of childbearing potential 
prior to starting any study interventions. 
 
 
5. Trial interventions 
 
The intervention portion of this study is the assignment to regular dressings and PICO 
negative pressure dressings  
 
5.1 Dressing application 
Subjects will be randomized to one of two post-operative wound treatments for LEB – 
standard gauze dressings or PICO negative pressure wound dressings. Subjects 
randomized to standard dressings will receive sterile gauze dressings as per standard 
practice. Subjects randomized to PICO negative pressure dressings will also have these 
placed in the operating room. Incision sites for both groups will be examined prior to 
discharge.  
 
5.2 Dressing removal 
On day POD 2, patients randomized to the standard dressing group will removal gauze by 
themselves at home. On POD7, patients randomized to the PICO group will have their 
dressing removed by a nurse or doctor in clinic. PICO single-use negative pressure 
dressing is marketed for use up to 7 days. 
 
5.3 Allocation to intervention 
Study participants will be randomized via an automatic program in the REDCap database 
(please see the Repository page for more information about this database). 
Randomization is instantaneous after pushing a generate button. Study group is 
automatically recorded in the patient’s data. Compared to drawing numbers or encoding 
information in separate sheets, this eliminates transfer of information between personnel 
and possibility of miscommunication. 
 
In REDCap, a randomization module is set up as part of the given project. Stratified 
randomization will be used according to treatment group. Randomization user rights will 
be granted solely to the Research Coordinator and Research Assistant to minimize 
investigator bias. If a person is given 'Randomize' privileges, they will be able to view 
and modify existing data already collected for the randomization strata fields (if 
stratification is used) when they are performing the randomization. 

8 
 
 
Since randomization will be performed during the pre-operative period, the patient will 
be aware of the surgical plan (open vs. endovascular) prior to the date of the surgery. He 
or she will then have an option to withdraw from the study and choose any appropriate 
treatment modality, if they so choose. 
 
 
6. Subject recruitment and consent 
 
6.1 Subject Identification 
Eligible patients will be identified by the clinical care team, who will notify a member of 
the study staff. 
6.2 Screening  
A member of the study staff will assess patient eligibility using the Preparatory to 
Research provision, as approved by the institutional review board (IRB). All protected 
health information used during the screening process of a potential subject will be the 
minimum necessary for the conduct of this study. Any protected information recorded 
will be destroyed at the end of the screening process. The clinical care team of the 
potential subject will be aware of the potential participation in this study as they will be 
the ones who refer the subject. 
For ineligible patients, only the eligibility criteria that were not met (i.e. which criteria 
excluded the patient from study participation) will be recorded. 
6.3 Recruitment and consent 
All residents, attending physicians, and research assistants who have undergone training 
to consent for this project and whose proficiency has been verified will be eligible to 
consent patients in clinic. After patient has agreed to hear more about the study and has 
affirmed his/her interest in participating, the consenter will review the consent form. The 
consenter will answer any questions the patient may have and ask if the patient would 
still like to participate. The consenter will then ask the patient to sign and date the 
document. The consenter will sign and date the document. A copy of the form will be 
made and given to the subject. 
 
 
7. Activities and measurements  
 
7.2 Data to be recorded at Baseline and Follow-up visits  
DEMOGRAPHICS AND MED HIS. 
  
Age, mean (SD), years 
  
Race, No. (%)  
  
  
White  
  
Black 
  
Hispanic 

9 
 
  
Asian/Pacific Islander Native 
American 
Sex, No. (%)  
  
  
Female  
  
Male 
Height, mean (SD) inches  
  
Weight, mean (SD) pounds  
  
BMI, mean (SD) kg/m2 
  
Prior CAD intervention (PTCA/CABG), 
No. (%) 
  
DM, No. (%)  
  
  
None 
  
IDDM  
  
NIDMM 
Renal function, No. (%)  
  
  
Normal 
  
Renal insufficiency (creatinine >2 
mg/dL)  
  
Dialysis 
History of  
  
  
Hypertension, No. (%) 
  
Myocardial infarction, No. (%)  
  
Stroke, No. (%) 
Laboratory values, mean (SD)  
  
  
WBC, ?109/L 
  
Hematocrit, % 
  
Platelets ?109/L  
  
Glucose, mg/dL 
  
Creatinine, mg/dL  
  
Albumin, g/dL 
  
Hemoglobin A1c, %  
  
C-reactive protein, mg/L 
Medications, No. (%)  
  
  
Aspirin 
  
ACE inhibitor Antibiotics 
  
b-Blocker Coumadina 
  
Low-molecular-weight heparin  
  
Clopidogrel  
  
Statin 
  
Steroids 
Smoking status 
  
  
  

10 
 
OPERATION INDIC. AND CHAR. 
  
Indication, No. (%)  
  
  
Claudication 
  
Critical limb ischemia  
  
Abdominal aneurysm  
  
Peripheral aneurysm  
  
Bypass revision  
  
Other 
Procedure side, No. (%)  
  
  
Left 
  
Right  
  
Bilateral 
Surgical site, No. (%)  
  
  
Femoral above-knee popliteal  
  
Femoral below-knee popliteal  
  
Femoral tibial/pedal  
  
Popliteal tibial/pedal  
  
Tibial/pedal  
  
Other 
Clean classification, No. (%) 
  
Sterile preparation solution, No. (%)  
  
  
Betadine based 
  
Chlorhexidine based  
  
Other 
Estimated blood loss, mean (SD), mL  
  
Operative time, mean (SD), minutes  
  
Incision length, mean (SD), cm 
  
  
  
WOUND COMPLICATIONS 
  
Patients with follow-up 
  
Worst complication  
  
  
No wound complication  
  
Other 
  
Wound dehiscence  
  
Superficial SSI  
  
Deep SSI 
Any SSI (superficial or deep)  
  
Any wound complication 
  
  
  
WOUND COMPLIC BY PT. CHAR 
  
Age 
  

11 
 
Race 
  
  
White  
  
Black  
  
Other 
Sex 
  
  
Female  
  
Male 
BMI 
  
Prior CAD intervention (PTCA/CABG)  
  
Abnormal renal function 
  
History of  
  
  
Diabetes (IDDM or NIDMM)  
  
Hypertension 
  
Myocardial infarction  
  
Stroke 
Indication  
  
  
Claudication 
  
Critical limb ischemia 
  
Abdominal aortic aneurysm  
  
Peripheral aneurysm  
  
Bypass revision  
  
Other 
Surgical site  
  
  
Groin only 
  
Groin and leg mixed 
  
All wounds lower than groin 
Nonclean classification 
  
Sterile preparation solution  
  
  
Betadine based 
  
Chlorhexidine based  
  
Other 
Estimated blood loss  
  
Operative time 
  
Total incision length 
  
Laboratory values  
  
  
WBC 
  
Hematocrit  
  
Platelets  
  
Glucose 
  
Creatinine  
  
Albumin 

12 
 
  
Hemoglobin A1c  
  
C-reactive protein 
Medication use  
  
  
Aspirin 
  
ACE inhibitors  
  
Antibiotics 
  
b-Blockers  
  
Coumadinb 
  
Low-molecular-weight heparin  
  
Clopidogrel  
  
Statins 
  
Steroids 
 
 
7.3 Baseline 
Baseline visit: 
• Sign informed consent 
• Baseline visit will include standard clinical procedures for PAD patients to 
undergo lower extremity bypass. Patients will be consented after clinical 
examination by a surgeon. 
• Baseline visit will include a review of past medical history, peripheral vascular 
history, allergies, and current medications. 
• Physical exam will include documentation of blood pressure, heart rate, weight, 
height, and a full body examination. 
• Assessment of cardiology risk stratification and LE symptoms. 
 
7.4 First study mode 
Study participants randomized to standard pressure dressings will remove their dressings 
and replace as necessary on post-operative day (POD) 2. Participants randomized to 
PICO dressings will have their dressings removed in clinic on POD 7.  
 
For the purpose of this trial, the following data will be collected at scheduled clinic visits 
(POD 7, POD 14, and POD 30). 
• Current signs/symptoms 
• Current medications 
• Vitals 
• Pain scale 
• Quality of life questionnaires 
• Percent of leg swelling measured 20 cm above and 15 cm below patella 
 
7.8 Data entry 
Research affiliates will enter all study data into the REDCap data application within 48 
hours of contact with the research subject. 

13 
 
7.9 Subject withdrawals 
Subjects may be withdrawn from the study for the following reasons: 
• Subject declines further study participation. 
• In the investigator’s judgment, it is in the subject’s best interest. 
 
All protocol-specified visits and follow-up procedures should be performed for every 
subject enrolled in the trial. If the subject refuses to continue with the study visits, every 
attempt should be made to continue contact by telephone, written communication, or 
record review to determine if outcome events have occurred, unless the subject 
specifically refuses such follow-up. The reason for withdrawal will be documented for all 
subjects withdrawn from the study. If the withdrawing subject is unwilling to have his/her 
medical records reviewed until the end of the trial period (to document vital status and 
cause of death), he/she must submit a written refusal. 
 
7.10 Stopping rules 
If a subject is removed from the study due to an SAE, no further subjects will be enrolled 
at the site until the site’s study team has: 
1) Assessed the SAE and determined its relationship to the study (“probably related” or 
“unlikely related”); AND 
2) Reviewed the frequency of all SAEs that have occurred at the site 
  
For the study as a whole: 
The study intervention will be stopped if any of the below conditions occur: 
1) Death of a subject determined to be caused by the study intervention 
2) 3 or more subjects experience an SAE 
 
7.11 Investigational Product Accountability 
It is the responsibility of the Principal Investigator at this site to ensure the appropriate 
use and disposition of the supplied PICO negative pressure dressings. A device 
accountability recording the make, model, and lot number will be maintained by the PI. 
At the completion of the study, there will be a final reconciliation of dressings used. 
 
 
8. Data analysis and statistical considerations 
 
8.1 Sample size determination 
The estimated average days to complete ambulation is 7 days. In order to detect a 
significance with estimated 7.5 days (a 7% change) with common SD=0.5 and 85% 
power, at a p=0.05, we would require 18 subjects. Allowing for a 20% loss of subjects 
after consent is obtained (due to subjects not meeting clinical stability criteria or because 
the subject and/or LAR withdrew permission to use data), the study requires a sample 
size of 22.5 subjects per group. Per funding restrictions for this project (by units 
provided), we plan to enroll 20 subjects per group, for a total of n=40. 
 
8.2 Analysis of endpoints 

14 
 
This study is intended to compare the post-operative recovery in patients using standard 
pressure dressings and PICO single-use negative pressure dressings. We will be 
measuring leg swelling, days to ambulation, and rates of infection. Relevant 
measurements will be taken at baseline and in subsequence clinical visits on POD 7, 14, 
and 30. In order to test for significance, we will use a unpaired t-test. An alpha level of 
0.05 will determine statistical significance. 
 
 
9. Risks and benefits of trial participation 
 
9.1 Potential risks  
1) As with any patient research, participation in this study poses a risk for breach of 
confidentiality.  RARE 
2) Taking part in more than one research study may be harmful to the subject.  If subjects 
are already taking part in another study, we ask that they let us know.  Subjects should 
not take part in more than one study at the same time, unless the subject and the 
investigators agree that the subject is not likely to be harmed, and the outcome of the 
study will not be disturbed.  RARE 
3) Patients may experience discomfort during application of either sterile moist dressings 
or PICO dressings. This would be on par with standard post-operative protocols LIKELY 
4) Dressings may cause irritation of skin and pain upon removal. This is a part of any 
wound care dressing regimen. LIKELY 
5) In rare cases, PICO negative pressure dressings have caused wound complications due 
to retention of dressing pieces in wounds, in certain cases causing tissue necrosis. 
6) Bleeding and resulting death have been reported serious adverse events. Bleeding has 
been associated with patients who use anti-clotting medication and have received blood 
vessel grafts in the leg. RARE 
7) As with any research study, there may be additional risks of participating that are 
unforeseeable or hard to predict. RARE 
 
9.2 Mitigation of potential risks  
1) To minimize the breach of confidentiality risk, we will not use the subject’s name or 
hospital number to identify them on any non-restricted study records. Instead a unique 
study number will be assigned to each subject. Access to REDCap will be granted only to 
study personnel listed on this protocol. 
2) Prior to consent for participation in this study, the consenter will discuss with the 
patient whether or not they are participating in another study. If so, the PI will discuss 
with the patient in private whether they are likely to be harmed by participating in this 
study. 
3) Application of dressings will be done according to standard clinical care. 
4) Removal of dressings will be done according to standard clinical care. Application and 
removal irritation will be minimized accordingly. 

15 
 
5) The study PI will review with patients the likelihood of these risks prior to and after 
randomization. If the PI determines that the participant, given their medical and surgical 
history, is at risk for a serious adverse event, the participant will not be a part of this 
study. 
6) Tissue remnants in wounds (rare) have been largely the result of PICO dressing used 
individually or in long-term care settings. Patients randomized to the PICO group will 
have their dressing removed on post-operative day 7 in the vascular surgery clinic. This 
will be done by a trained nurse, resident, or attending physician. 
 
9.3 Potential benefits and risk‐to‐benefit ratio 
PICO is a potential tool for minimizing post-operative complications, but it has not yet 
been systematically tested in patients who have undergone lower-extremity bypass 
operations. The knowledge and insights emanating from this study will potentially 
advance research efforts surrounding negative pressure wound therapy and PICO single-
use dressings. They may also change how we treat post-operative wounds in the future. 
 
Subjects may not receive any direct benefit from participating in this study. The 
individual has the opportunity to use a potentially more effective wound dressing at no 
cost to him/her. Additionally, the subject will be contributing to an effort to improve 
post-operative care of lower-extremity bypass patients. Existing treatment still results in 
considerable leg swelling and wound complications, and subjects will aid in determining 
whether PICO is a viable therapy. 
  
All study costs not related to standard clinical care and performed solely for the purpose 
of research will be paid for by the sponsor. 
 
 
10. Adverse events and unanticipated problems 
 
10.1 Adverse event definitions 
Adverse event (AE) 
An adverse event is defined as any untoward or unfavorable medical occurrence in a 
human subject including any abnormal sign, symptom, or disease temporally associated 
with the subject's participation in the research, whether or not considered related to the 
subject's participation in the research. 
Serious adverse event (SAE) 
A serious adverse event is defined as any adverse event that meets one of the following 
criteria:  Results in death; OR 
 Is life‐threatening; OR   Prolongs hospitalization; OR   Results in persistent 
disability; OR   May jeopardize the subject's health; OR   May require medical or 
surgical intervention. 
Unanticipated problem (UP)  An unanticipated problem is defined as an event that 

16 
 
meets all of the following criteria:  
1)  Unexpected in severity, nature, or frequency given the research procedures and the  
characteristics of the subject population (i.e., problems that are not described in this 
protocol or  other study documents); AND  
2)  Related or possible related to participation in the research; AND  
3)  Suggests that research places subjects or others at a greater risk of harm related to the 
research  than was previously known or recognized.  
 
10.2 Severity assessment 
Sites will assess the severity of all adverse events according to the following scale: 
 Mild = not requiring treatment  
Moderate = resolved with treatment  
 Severe = inability to carry on normal activities and required professional medical 
attention  
10.3 Causality assessment 
The Site PI will determine the relationship of adverse events to the research intervention 
using the following scale: 
 Definite = AE is clearly related to the study procedures  
 Probable = AE is likely related to the study procedures  
 Possible = AE is possibly related to the study procedures 
 Unlikely = AE is doubtfully related to the study procedures  
 Unrelated = AE is clearly not related to the study procedures 
 
10.4 Procedures for recording and reporting adverse events  
 
• SAE: Any SAE will be reported to the BUMC IRB within 48 hours. DSMC to 
confirm receipt of notification.  
• All SAEs will be included in a report to the BUMC IRB every three months.  
• UP: The AE Coordinator will notify the BUMC IRB of all UPs within 48 hours. 
DSMC to confirm receipt of notification.  
• All UPs will be included in a report to the BUMC IRB every three months.  
• AE: All other AEs will be reported to the BUMC IRB on a quarterly basis. 
 
11. Administrative requirements 
 
11.1 Good clinical practice  
The study will be conducted in accordance with FDA and ICH guidelines for Good 
Clinical Practice. All study staff will be thoroughly familiar with the contents of this 
protocol and associated trial materials. 

17 
 
 
11.2 Data quality assurance  
The investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the study for each study 
subject. Study data will be entered into an electronic case report form (eCRF) by site 
personnel using a secure, validated, web‐ based electronic data capture (EDC) 
application. The coordinating site will have access to all data entry upon entry in the EDC 
application. Any changes made to study data will be made to the eCRF and documented 
via an electronic audit trail associated with the affected eCRF. 
 
11.3 Electronic case report form completion  
Study sites will be provided with secure access to and training on the EDC application 
sufficient to permit site personnel to enter or correct information in the eCRFs for the 
subjects for which they are responsible. ECRFs will be completed for each study subject. 
It is the investigator’s responsibility to ensure the accuracy, completeness, clarity and 
timeliness of the data reported in the subject’s eCRF. The investigator or designated 
representative shall complete the eCRF as soon as possible after the information is 
available. 
 
11.4 Study monitoring  
Due to financial and staff limitations there are no formal plans to monitor data for this 
study; however there remains a possibility for this if deemed necessary. All information 
recorded on the eCRF for this study must be consistent with the subject’s source 
documentation. Should monitoring occur, the study monitor may review protocol 
compliance, verify eCRFs against source documentation and ensure the protocol is being 
conducted according to pertinent regulatory requirements. Any review of medical records 
will be performed in a manner to ensure patient confidentiality is maintained. 
 
11.5 Ethical consideration 
The study will be conducted in accordance with ethical principles founded in the 
Declaration of Helsinki. The IRB will review all appropriate study documentation in 
order to safeguard the rights, safety and well‐being of the subjects. The study will only be 
conducted at sites where IRB approval has been obtained. The protocol, informed consent 
form, written information given to the patients, safety updates, annual progress reports 
and any revisions to these documents will be provided to the IRB by the investigator. 
 
11.6 Patient confidentiality  
Subject confidentiality of protected health information will be maintained by utilizing 
secure encrypted database for data collection and transmission with special security 
provisions in place for subject confidentiality protection. The database will be access on 
password and login protected computer only in the Department of Surgery with research 
staff access only. 
 
Study data will contain identifiers (e.g. social security numbers, medical records, date of 
birth). We will not collect any paper records and only highly secure encrypted electronic 
REDCap database will be utilized for data collection and transmission. REDCap database 

18 
 
has special provisions in place to ensure security and protection of identifiable research 
subjects information. 
 
All study data will be kept for three years after completion of the study. All data will be 
destroyed by deletion from computer files and/or shredding. 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). Those regulations require a signed subject authorization informing the subject 
of the following: 
  What protected health information (PHI) will be collected from subjects in this study  
  Who will have access to that information and why  
  Who will use or disclose that information  
  The rights of a research subject to revoke their authorization for use of their PHI.  
 
11.7 Investigator compliance  
The investigator will conduct the trial in compliance with the protocol approved by the 
IRB. Changes to the protocol will require written IRB approval prior to implementation, 
except when the modification is needed to eliminate an immediate hazard(s) to subjects. 
11.8 Subject cost and payment  
Cost: Subjects will not incur additional costs due to their participation in this study. Study 
materials will be paid for by the study grant. 
 
Payment: Subjects will not be paid for participation in this study. 
 
12. Funding Sources 
This study is funded through an investigator-initiated grant from Smith&Nephew. Solely 
de-identified data will be viewable to the sponsor.  
 
13. References 
1) Greenblatt et al. “Predictors of surgical site infection after open lower extremity 
revascularization.” Journal of Vascular Surgery. 2011. 54 (2): 433-9. 
2) Ozaki et al. “Prospective, randomized, multi-institutional clinical trial of a silver 
alginate dressing to reduce lower extremity vascular surgery wound complications.” 
Journal of Vascular Surgery. 2014. In publication. 
3) McPhee et al. “Risk prediction of 30-day readmission after infrainguinal bypass for 
critical limb ischemia.” Journal of Vascular Surgery. 2013. 57 (6): 1481-8. 
4) Kent et al. “Prospective study of wound complications in continuous infrainguinal 
incisions after lower limb arterial reconstruction: Incidence, risk factors, and cost.” 
Surgery. 1996. 119 (4): 378-383. 
5) Leak K, “A case-series appraisal of a single-use Negative Pressure Wound Therapy 
system in secondary care”, presented at WOUNDS UK, 2011 

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