Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
Phase: NA
Conditions: Bleeding
Sponsor: Wound Care 360, Inc.

Clinical Study of the WoundCare360 SiteSeal Adjunctive 
Compression Device Following Interventional Endovascular 
Procedures – NCT03234894 
 
Study Protocol:  
 
Document Date: October12, 2015 
 
 
 

 
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PROTOCOL 
 
SiteSeal™ Adjunctive Compression Device 
__________________________________________________________________ 
 
1. STUDY TITLE:  
Clinical Study of the Wound Care 360° SiteSeal™ Adjunctive 
Compression Device Following Interventional Endovascular Procedures 
 
2. PRINCIPAL INVESTIGATOR: 
 
Matthew B. Earnest, MD 
University of Kansas Medical Center 
3901 Rainbow Blvd., Mail Stop 1039 
Kansas City, KS.  66160 
 
 
3. SPONSOR:  
 
 
 
 
 
 
 
Wound Care 360° Inc. 
10900 S. Clay Blair Blvd 
Suite 800 
Olathe KS 66061 
 
4. CLINICAL FACILITY:  
Cardiac Intervention Lab 
 
 
 
 
 
University of Kansas Medical Center 
 
 
 
 
 
 
5. STUDYMONITOR 
Thomas Reidy 
 
6. PROTOCOL DATE 
October 12, 2015 
 
7. PROTOCOL NUMBER 
15-012 
 
8. Version 
1.2 
 
9. Purpose 
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive 
Compression Device across a broad array of patients undergoing interventional 
endovascular procedures. 
 
10. Synopsis 
The study design is a single arm with 90 patients.  The primary endpoints measure the 
risk for common femoral nerve damage and common femoral artery laceration from the 
blind placement of a Z-stitch in the soft tissue above the femoral bundle.  
 
The sample size is 90 patients. The project objective is to demonstrate the safety of the 
device. 

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11. TRIAL PHASE 
Pivotal Clinical Trial 
12. NAME OF DEVICE 
SiteSeal™ 
13. INTENDED USE 
 
SiteSeal™ is intended for use in the compression of the femoral artery after cannulation.  
The device is intended for professional use only. 
 
14. Background Information 
 
Summary of Original Study Protocol in Pre-Submission 
 
Achieving hemostasis after vascular procedures performed from the femoral artery 
approach is a vital component in the ultimate success of the procedure. Vascular 
complications are rare, but impart a significant amount of morbidity and mortality to the 
patient when they occur. The current “Gold Standard” is manual compression, which 
involves external pressure applied to the femoral artery cranial to the access site, with 
visual confirmation of hemostasis. Most current protocols demand 15-30 minutes of firm 
pressure be applied during this portion of the procedure to achieve hemostasis, followed 
by up to 6hours lying flat on a hard surface before ambulation. This can be very 
uncomfortable to the patient, and is difficult to maintain for the individual tasked with 
holding pressure. There is significant variability between patients with relation to body 
habitus and overall size. There is also variability in the skill and experience of the 
technician holding pressure. 
 
About half of the procedures are closed using a variety of vascular closure devices (VCD).  
VCDs leave something behind in the patient, but are quick to deploy, reducing the time 
to achieve hemostasis.  There is considerable skill required to place VCDs successfully.  
As a result, different types of VCD appeal to different physicians.  The skilled doctor uses 
the VCD that the physician determines is best for his/her patient. 
The SiteSeal™ device is not a VCD; it is an adjunctive compression device. 
 
The SiteSeal™ device is placed in the catheterization laboratory, using three separate 
steps to improve hemostasis and remove closure process variability while leaving nothing 
behind. A Z-stitch is used to secure adjacent non-involved tissue and involute it over the 
arteriotomy site, while BioSeal powder is used to seal the wound tract itself. Compression 
is applied and maintained via the Adjunctive Compression Device that is sutured in place 
after being aligned with the sheath itself, ensuring proper positioning, and eliminating 
variability in pressure. The operating physician deploys the device in a minimal amount 
of time.   
 

 
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Time to hemostasis (TTH) varies with manual compression based on many variables.  
TTH with VCDs is really the time to deploy the device since hemostasis is achieved as 
soon as deployment is complete.  TTH is the time to form an immature clot; TTA is the 
time to form a mature clot.  TTA is also economically relevant as a bed is freed up only 
after ambulation and not after hemostasis.  This trial compares an adjunctive hemostasis 
device to a VCD.  The relevant effectiveness measure is TTA. 
 
We postulate that the Wound Care 360° SiteSeal™ Adjunctive Compression Device is 
not inferior to Perclose VCD for safety during placement, time to hemostasis, time to 
ambulation, deployment safety, time to discharge, patient comfort and vascular 
complications associated with catheterization procedures performed via femoral artery 
access.  The results of the trial are to quantify the safety and efficacy of the device and 
not to draw comparisons with other closure strategies.  The primary outcome is to assess 
the risk for common femoral nerve damage and common femoral artery laceration. 
 
The proposed Indication For Use is: 
 
 
"The SiteSeal™ System is indicated for use in the compression of the femoral 
artery or vein after vessel cannulation." 
 
15. OBJECTIVE 
 
Primary: The primary endpoints assess the risk for common femoral nerve damage and 
common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue 
above the femoral bundle. 
 
Secondary: The secondary endpoints are to measure patient discomfort (per 24-hour 
phone interview), and the 30-day incidence of major and 30-day incidence of minor 
complications (per patient follow-up visit). 
 
Patient Discomfort: 
a. Patient discomfort @ discharge from the catheterization lab: 
b. Patient discomfort @ 24 hours after the procedure: 
30day Major Complications: 
a. Vascular repair or the need for vascular repair (via surgery, ultrasound guided 
compression, transcatheter embolization, or stent graft) 
b. Access site related bleeding requiring transfusion 
c. Any new ipsilateral lower extremity ischemia documented by patient symptoms, 
physical exam, and/or decreased or absent blood flow on lower extremity 
angiogram 
d. Surgery or the need for surgery for access site related nerve injury 
e. Permanent (lasting >30 days) access site related nerve injury 
f. Access site related infection requiring intravenous antibiotics and/or extended 

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hospitalization 
30Day Minor Complications: 
a. Non treated pseudoaneurysm documented by ultrasound 
b. Non treated arteriovenous (AV) fistula documented by ultrasound 
c. Pseudoaneurysm treated with ultrasound guided thrombin injection or ultrasound 
guided fibrin adhesive injection 
d. Access site hematoma greater than or equal to 6 cm 
e. Access site related bleeding requiring greater than 30minutes to achieve 
hemostasis 
f. Late (following hospital discharge) access site related bleeding 
g. Ipsilateral lower extremity arterial emboli 
h. Transient loss of ipsilateral lower extremity pulse 
i. Ipsilateral deep vein thrombosis 
j. Access site related vessel laceration 
k. Transient access site related nerve injury 
l. Access site wound dehiscence 
m. Localized access site infection treated with intramuscular or oral antibiotics 
 
16. PATIENT POPULATION 
 
This study will be performed on "all comers" requiring interventional femoral artery 
procedures who meet the inclusion and exclusion criteria. 
 
 
Inclusion Criteria 
 
 
1. Patients between the ages19 to 90 
2. Patient or his/her legally authorized representative, has given written informed consent 
for participation prior to the procedure 
3. Procedure is an interventional procedure 
4. Patient is willing to undergo all study procedures and adhere to data collection and 
follow-up requirements 
5. Patient is a candidate for elective, non-emergent cardiac or peripheral vascular 
catheterization from the femoral artery approach 
6. Patient is willing to have a pre/post procedure ultrasound. 
 
 
 
Exclusion Criteria 
1. Patients are <19 years old 
2. Patients are  >90years old 
3. Patient has received Glycoprotein (GP) IIb/IIIa inhibitors 
4. Patient or patient's representative is unable to provide written informed consent.  

 
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5. Patient is unable or unwilling to adhere to data collection and follow-up 
requirements 
6. Procedure is emergency Percutaneous Coronary Intervention (PCI) 
7. Patient is on dialysis 
8. Patient has a known diagnosis of fibromyalgia 
9. Patients with acute coronary syndrome (i.e., unstable angina or myocardial 
infarction) ≤ 48 hours before this catheterization procedure. 
10. Patients with systolic blood pressure < 90 mm Hg at the end of the catheterization 
procedure 
11. Patients who are immunocompromised 
12. Patients with preexisting systemic infection or local infections at the access site 
13. Patients who are known or suspected to be pregnant, or are lactating 
14. Patients who have undergone prior or recent use of an intra‐aortic balloon pump 
through the arterial access site above the inguinal ligament 
15. Patients who have undergone prior vascular closure device use in the ipsilateral 
common femoral artery ≤ 30days before this catheterization procedure 
16. Patients who have undergone prior use of manual or mechanical compression for 
closure in the ipsilateral common femoral artery ≤30 days before the 
catheterization procedure 
17. Patients requiring a repuncture at a site previously punctured within 48 hours of the 
catheterization procedure 
18. Patients who have undergone an antegrade puncture 
 
19. Patients with puncture sites believed to be in the profunda femoris artery, 
superficial femoral artery, or at the bifurcation of these arteries 
20. Patients with puncture tract angle >55° 
 
21. Patients who are suspected to have experienced a femoral artery back wall 
puncture or who underwent > 1femoral artery puncture during the catheterization 
procedure 
22. Patient with significant anemia (hemoglobin < 10 g/dL, Hct < 30%) 
23. Patients with a known bleeding disorder, including thrombocytopenia (platelet 
count < 100,000 cells/μL), thrombasthenia, hemophilia, or von Willebrand’s disease 
 
24. Patients with systolic blood pressure >180 mm Hg or diastolic blood pressure >110 
mm Hg at the end of this catheterization procedure, unless systolic and/or diastolic 
pressure was lowered by pharmacological agents prior to the end of the 
catheterization procedure 
 

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25. Patients with a baseline International Normalized Ratio (INR) >1.5 (e.g., on 
warfarin therapy) 
26. Patients whose Activated Clotting Time (ACT) >300seconds at the end of the 
catheterization procedure 
27. Patients who have undergone administration of low molecular weight heparin 
(LMWH) within 8hours of this catheterization procedure 
 
28. Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is 
planned for this patient (with the exception of glycoprotein IIb/IIIa inhibitor therapy) 
during the first few hours following the catheterization procedure 
 
29. Patients having a complication or complications at the femoral artery access site 
during the catheterization procedure including bleeding, hematoma, intraluminal 
thrombus, pseudoaneurysm, or arteriovenous fistula 
30. Patients with an ipsilateral or bilateral lower extremity amputation(s) 
 
31. Patient known to require extended hospitalization (e.g., patient is undergoing 
cardiac surgery) 
32. Patients who have a planned endovascular procedure within the next 30days after 
the catheterization procedure 
33. Patients who are currently participating in another investigational study that has not 
concluded the follow-up period 
34. Patients who have already participated in the Investigational Device Exemption 
(IDE) study 
35. Patients who cannot adhere to or complete the study for any reason including but 
not limited to geographical residence or life-threatening disease 
 
 
17. NUMBER OF INVESTIGATIONAL SITES 
 
The trial will be performed at two sites with multiple practitioners.   
 
Consideration was given to using a single vs. multiple sites as well as multiple 
practitioners.    Practically, we found a learning curve in our pilot study in which proficiency 
(measured as deployment time < 3minutes in simple diagnostic procedures) stabilized 
after about n= 2-3 per practitioner.  Given n= 90 for the study with all cases consisting of 
more complex interventional procedures, if the total number of practitioners were 6 (e.g. 
2 hospitals*3 practitioners/hospital), for example, then each physician would do 15 cases, 
or about 5 times the number it takes to become proficient.  We decided that two sites with 
multiple practitioners would satisfy the requirement to minimize bias without introducing 
excessive start-up variation. 
 
18. METHODS / STUDY DESIGN 

 
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Institutional Review Board (IRB) approval will first be obtained.  A subject's participation 
is a one-time event (plus follow-up) that occurs after obtaining informed consent.  The 
subjects will not incur any costs associated with the study procedures. 
 
At the catheter lab site, subjects will be screened through a standard of care history.   After 
determining that the patient qualifies for enrollment into the study, an investigator or 
delegated study personnel will obtain an informed consent.  After the patient's informed 
consent is obtained, study personnel will interview the subject and document subject data, 
including their age, gender, race, and patient history into their file.  The subject source 
data is then recorded on a sponsor-provided Case Report Form (CRF). 
 
Each subject will undergo the doctor-determined interventional procedure before closing 
with SiteSeal™. 
 
The first 50 patients will receive a pre-device deployment ultrasound of the access site 
on the day of catheterization and a post-procedure ultrasound (after device removal and 
no later than the 30day follow-up) to detect silent complications, including vascular injury 
requiring repair, pseudoaneurysms requiring thrombin or fibrin adhesive injections, or 
bleeding requiring transfusions. 
 
 
All patients will return for a follow-up visit at 30 days (+1week) post-procedure. A 
physician investigator (i.e. principal investigator, sub-investigators, physician assistants 
and/or nurse practitioners associated with the investigators) will examine the femoral 
artery access site.  Any access site-related complications will be reported to the PI. 
 
19. ANALYSIS OF RESULTS 
 
For each patient, a separate set of Case Report Forms (CRFs) will be completed and 
comprise the following information: 
 
• Inclusion/exclusion criteria 
• Demographics: Age in years, Sex, Race, Height, Weight, BMI. 
• Procedure-Related Data 
• Medication history  
• Previous diagnostic and/or interventional endovascular procedures                                        
• Catheterization procedure data 
 
Primary Endpoints 
• Risk for common femoral nerve puncture and common femoral artery 
laceration (or needle penetration) from blind placement of the Z-stitch. 
o Nerve puncture risk is defined as "the incidence of an involuntary leg 
muscle contraction and an auditory response at the time of placing the 
device". 

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o Common femoral artery laceration (or needle penetration) is defined as 
"a common femoral artery laceration (or needle penetration) with 
resultant bleeding or hematoma > 6 cm diameter". 
Secondary Endpoints 
• Patient Discomfort @ discharge from the catheterization lab and @ 24 
hours’ post procedure (per phone interview) 
a. 1-10 scale with 10 being intense pain 
• Assessment of complications (major and minor) 30days after leaving the 
catheterization lab (per visit to physician investigator). 
Major complications:   
b. Vascular repair or the need for vascular repair (via surgery, 
ultrasound-guided compression, trans-catheter embolization, or 
stent-graft) 
c. Access site-related bleeding requiring transfusion 
d. Any new ipsilateral lower extremity ischemia documented by patient 
symptoms, physical exam, and/or decreased or absent blood flow 
on lower extremity angiogram 
e. Surgery or the need for surgery for access site-related nerve injury 
f. Permanent (lasting > 30 days) access site-related nerve injury 
g. Access site-related infection requiring intravenous antibiotics and/or 
extended hospitalization 
Minor Complications 
a. Non-treated pseudoaneurysm documented by ultrasound 
b. Non-treated arteriovenous (AV) fistula documented by ultrasound 
c. Pseudoaneurysm treated with ultrasound-guided thrombin injection 
or ultrasound-guided fibrin adhesive injection 
d. Access site hematoma greater than 6cm 
e. Access site-related bleeding requiring greater than 30minutes to 
achieve hemostasis 
f. Late (following hospital discharge) access site-related bleeding 
g. Ipsilateral lower extremity arterial emboli 
h. Transient loss of ipsilateral/contralteral lower extremity pulse 
i. Ipsilateral deep vein thrombosis 
j. Access site-related vessel laceration 
k. Transient access site-related nerve injury 
l. Access site wound dehiscence 
m. Localized access site infection treated with intramuscular or oral 
antibiotics 
 
20. SAFETY/RISKS 
 

 
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The study device comprises no risks that are in addition to manual compression with the 
exception of placing a blind suture around the arteriotomy site.   
 
The blind suture carries a risk of damaging the common femoral nerve (CFN) or lacerating 
(or needle penetration of) the common femoral artery (CFA).  
 
Several steps are taken to mitigate this risk. 
 
1. The J195 suture uses a CP needle and needle holder with maximum possible 
depth of 12 mm (proximity control). 
 
2. The nerve is posterior (beneath) and lateral to the common femoral artery.  A 
portion of the psoas major muscle separates the common femoral nerve from 
the common femoral artery and thus is deeper than 12mm and too far lateral. 
 
3. Revised IFU instructions teach lifting the obturator/sheath vertically to stretch 
soft tissue away from the femoral vessel and then place the needle through the 
elevated soft tissue on patients where the doctor assesses that the common 
femoral artery is too close to the skin surface. 
 
4. The obturator remains in place inside the sheath for resistance control during 
the second needle penetration. The needle can penetrate the vessel wall 
(pinprick).  
a. SiteSeal™ pressure upstream and downstream of the access site allows 
natural clotting to seal a vessel puncture by the needle. The attending 
doctor determines when to remove the device and ambulate the patient.  
The device remains deployed until the doctor determines that a mature 
clot has formed. 
5. The Z-stitch penetration can potentially penetrate the vessel wall.  Blood will 
flow between the 1.5Fr suture and suture track (path of least resistance) and 
be immediately obvious to the doctor. 
 
6. The mitigation is to remove the suture and needle and then use manual 
pressure to seal the breach. 
 
7. A new contraindication statement says: "Avoid use of SiteSeal™ Adjunctive 
Compression Device if the arterial access is at or above the inguinal ligament."  
 
The CFA rises towards the skin surface after the inguinal ligament and then 
falls.  The access site should be 2-3cm downstream of the inguinal ligament so 
that the CFA is falling where the Z-stitch is placed. 
 
 
21. DATA SAFETY AND MONITORING COMMITTEE 

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The Data Safety and Monitoring Committee (DSMC) members are: 
Robert Nesbit, M.D. – Surgeon 
Craig Walker, M.D. – Cardiologist 
Frank Bunch, M.D. – Cardiologist  
 
Their CVs are in the CV Section of the IDE. 
 
The committee will meet before the trial begins and at least twice during the trial.  The 
pre-trial objective is to predict (to the extent possible) adverse events or outcomes before 
the trial begins.  During the trial, the Committee will review adverse events, if any.  The 
Committee will recommend study termination if safety concerns warrant such action.  The 
DSMC will concurrently serve as an independent Clinical Events Committee (CEC). 
 
22. MONITORING PROTOCOL 
 
II. Monitors 
a. Thomas Reidy 
i. CEO 
ii. (816) 260-8476 
iii. treidy@woundcare360.com  
CEO/President:  In-Vitro Medical Diagnostics career with more than thirty-
five years of progressive professional experience in management, that 
included the reorganizing and streamlining of all departments in both the 
Medical Laboratory and Medical Device space with FDA, PMA, and CLIA 
oversight that resulted in bringing new products to market and the 
establishment of international distributors that resulted in 45% of total sales.  
 
Mr. Reidy was responsible for the overall management of all aspects of 
Primus Diagnostics, a medical diagnostic company. 
 
Thomas Reidy co-developed the protocol, the investigational device, the 
written informed consent form and all documents provided to subjects, 
applicable regulators and to the Principal Investigators. 
 
b. Rex Teeslink, MD 
(706) 373-5771 rexteeslink@bellsouth.net  
Dr. Teeslink's Curriculum Vitae is in the IDE CV Section. 
III. Purpose 
a. To verify that the rights and wellbeing of human subjects are protected. 
b. The reported trial data are accurate, complete and verifiable from source 
documents. 
c. The conduct of the trial is in compliance with the currently approved 
protocol, with GCP and with the applicable regulatory requirements. 
IV. Extent and Nature of Monitoring 
a. The Monitor is the main line of communication from the Sponsor to the PI 

 
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V. Monitoring site visit (biweekly) 
VI. Monitoring report 
a. The monitor will submit a written report to file after each trial-site visit or 
trial communication with the PI. 
b. Reports will include the date, site, name of the investigator or other 
individual contacted. 
c. Reports will include a summary of what was reviewed and the 
findings/facts, deviations and deficiencies, conclusions, actions taken 
and/or actions recommended to secure compliance. 
d. In the event of a non-compliant investigator, the deficiency will be pointed 
out, documented and corrective action initiated. 
e. In the event of repeated non-compliance, the investigator will be dropped 
from the trial 
f. Data from an incomplete CRF will not be used in the statistical analysis. 
 
 
 
 

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23. TRAINING 
 
Dr. Rex Teeslink, co-inventor of the device will train the investigators on the use of the 
SiteSeal™ device, trial protocol and record keeping in both classroom and lab 
environments. Each investigator will have 2roll-in placements before beginning the trial.  
The results of the roll-in patients will be collected, but not tabulated as part of the trial. 
 
24. DISPERSION, STORAGE & RETURN OF DEVICE 
 
Upon site receipt of device, an inventory must be performed and a device receipt form 
filled out and signed by the person accepting the shipment.  The date the device was 
received, the number of devices received, the lot number of the device and the person 
who received device must be documented on a Site/Dispersion/Return Log.  Any 
damaged device will be documented and the sponsor notified immediately. 
 
25. STUDY OVERSIGHT 
 
This study is evaluating an investigational device.  The decision to stop the study will be 
made by the CEO, Chief Medical Officer for Woundcare360 LLC and the VP Quality and 
Regulatory Affairs.  
 
26. STATISTICAL PLAN 
 
Objective 
The purpose of this study is to establish the safety of the SiteSeal™ Adjunctive 
Compression Device.   
 
Study Design 
The study design is a single arm with 90 enrolled patients, open-label, single center 
clinical trial. 
 
Handling Missing Data 
No imputation will be done for missing data. 
 
Handling Dropouts 
The numbers of patients who enter and complete the trial will be tabulated, and details 
concerning reasons for withdrawals will be listed.   
 
 
 
 
Statistical Methods 
 

 
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Primary Safety Analyses 
For the risk of each of the two primary safety endpoints, namely common femoral nerve 
puncture and common femoral artery laceration, percent of patients exhibiting the risk 
and its one-sided 95% upper confidence limit will be shown.  We expect very low risk for 
the above two endpoints.  In case that we observe no cases for each of the above 
endpoints, with 90 patients for the device group, we can claim that we are 95% confident 
that the risk is less than 3.3%. 
 
Secondary Safety Analyses 
For the risk of each of the major complications and minor complications, percent of 
patients exhibiting the risk and its two-sided 95% upper confidence interval will be shown.  
For the score of patient discomfort, the mean score and its 95% two-sided confidence 
interval will be reported. 
 
Baseline Patient Characteristic Data 
For each of quantitative baseline data such as age, height, BMI, and blood pressures, 
etc., the mean score and its 95% two-sided confidence interval will be reported. 
 
For each of qualitative baseline data such as procedure type, presence or absence of 
peripheral vascular disease, and size of the introducer sheath, etc., its frequency 
distribution will be shown.   
 
Populations for Analysis 
All patients in this study are expected to receive the test device, and they will be 
categorized as intent-to-treat (ITT) patient population.  All analyses will be conducted 
based on this ITT population. 
 
The calculations will be performed using SAS software for Windows1, Version 9.4, 
Copyright (c) 2002-2012 by SAS Institute Inc., Cary, NC, USA.   
References  
 
1. SAS OnlineDoc Version Nine for the Web, SAS Institute Inc., Cary, NC, USA. 
http://support.sas.com/documentation/onlinedoc/sas9doc.html 
 
 
 

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27. DATA MANAGEMENT 
 
The data will be owned and maintained by Woundcare360 LLC.  Woundcare360 LLC will 
analyze the data. This analysis may be provided to the FDA.  A description of this clinical 
trial will be available on http://ClinicalTrials.gov as required by US Law.  This website will 
not include information that can identify subjects.  Subjects can search this website at any 
time.  The data may be used for presentations and submitted to journals.  All subject 
matter will remain confidential, and at no time will any subject names or other identifying 
data be used. 
 
28. IRB REVIEW 
 
The IRB for MOVI is: 
Quorum Review IRB 
1501 Fourth Ave. Suite 800 
Seattle WA 98101 
 
The IRB Chairman is Stephen Rosenfeld MD. 
 
The protocol, informed consent document and relevant supporting information must be 
submitted to the IRB for review and must be approved before the study is initiated.  In 
addition, any subject recruitment materials must be approved by the IRB prior to being 
used.  This study will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki and that are consistent with Good Clinical 
Practice and applicable regulatory requirements.  The study must be conducted in 
accordance with the regulations of the United States Food and Drug Administration (FDA) 
as described in 21CFR 50 and 56 and 812, applicable laws and the IRB requirements. 
 
The sponsor must submit any change to the protocol to the IRB for review and approval 
before implementation.  A protocol change intended to eliminate an apparent immediate 
hazard to subjects may be implemented immediately provided the FDA and the reviewing 
IRB are notified within 5 working days. 
 
It is the responsibility of the investigator to provide each subject with full and adequate 
verbal and written information using the IRB approved informed consent document, 
including the objective and procedures of the study and the possible risks involved before 
inclusion in the study.  Informed consent must be obtained prior to performing any study-
related procedures, including screening and changes in medications, including any 
washout of medications.  A copy of the informed consent must be given to the study 
subject. 
 
29. CONFIDENTIALITY 
 
As described above all data will be analyzed by Woundcare360 LLC.  The data may also 
be used for presentations and submitted to journals.  If any results are published, the 
subject's identity will remain confidential and at no time will any patient names or other 

 
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identifying data be used.  A monitor, auditor, IRB and/or other regulatory authorities will 
have access to study-related medical records, as this information is necessary for our 
study.  All study related records identifying the subject will be kept confidential and, to the 
extent permitted by applicable laws and/or regulations will not be made publically 
available. 
 
 
QA Review and Approval ____________________________ Date ____________ 
 
 
 
 
CEO/President Review and Approval ____________________ Date ___________ 
 
 
 
 

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