An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
Phase: NA
Conditions: Adverse Events
Sponsor: Irrimax Corporation

IRRIMAX CORPORATION 
AN INDEPENDENT REVIEW OF SAFETY DATA FROM A CLOSED CLINICAL STUDY 
USING IRRISEPT (PROTOCOL # IRR-CT-901-2013-01)  
 
Protocol Short Title:   
Retrospective Independent Safety Review of Closed Irrisept Study 
Protocol Identifying Number:   
CLP-01  
Sponsor:  
Irrimax® Corporation 
1665 Lakes Parkway, Suite 102 
Lawrenceville, GA 30043 
Protocol Version and Date:   
Version 1.0; 9 December 2019 
Chief Medical Officer:  
Gerry Klein, MD 
 
gklein@medsurgpi.com 
919-930-9180 
Sponsor Contact: 
Chevy Brown, MPH, CCRC 
 
Clinical Trials Manager 
Irrimax Corporation 
 
Chevy.Brown@irrisept.com 
 
770-807-3355 (Ext. 15) 
Independent Medical Monitor: 
Roger Morgan, MD, FACS 
 
rmorgan@medsurgpi.com 
 
919-931-9799 
Contract Research Organization: 
Peachtree Bioresearch Solutions, Inc. 
 
4985 Lower Roswell Road, Suite #200 
 
Marietta, GA 30068 
 
678-373-4660 
 
This document is CONFIDENTIAL and PROPRIETARY and shall not be disclosed without written consent 
from Irrimax Corporation.  It is for use by the Principal Investigators and their designated 
representatives participating in this clinical investigation.  It should be held confidential and 
maintained in a secure location.  It should not be copied or made available for review by any 
unauthorized person or firm. 
 

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Protocol CLP-01 Version 1.0; 9 December 2019        CONFIDENTIAL AND PROPRIETARY 
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Principal Investigators/Study Sites: 
 
 
Site #1  
Jeffrey Claridge, MD 
 
 
 
MetroHealth Medical Center  
 
 
 
Dept. of Trauma, Critical Care & Burns 
 
 
 
2500 MetroHealth Drive  
 
 
 
 
 
Cleveland, OH 44109 
 
 
 
 
 
 
 
Site #2 
Martin Croce, MD 
 
 
 
University of Tennessee Health Science Center (HSC) 
 
 
 
 
 
Elvis Presley Trauma Center 
 
 
 
 
 
877 Jefferson Avenue, Room AG69 
 
 
 
 
 
Memphis, TN 38103 
 
 
 
 
 
 
 
Site #3 
Donald Davis, MD 
 
 
 
Tampa General Hospital 
 
 
 
University of South Florida (USF) College of Medicine 
 
 
 
 
 
5 Tampa General Circle HMT, Suite 740  
 
 
 
 
 
 
Tampa, FL 33606 
 
 
 
 
 
 
 
 
 
 
Site #4 
Ernest Moore, MD 
 
 
 
Denver Health Medical Center 
 
 
 
601 Broadway 6th Floor MC0220 
 
 
 
 
 
Denver, CO 80203 
 
 
 
 
 
 
 
 
 
 
 
 
Site #5 
Laura Moore, MD 
 
 
 
University of Texas Health Science Center (UTHSC) at Houston  
 
 
 
Center for Translational Injury Research  
 
 
 
 
 
6410 Fannin St., UPB 1100.17 
 
 
 
 
 
Houston, TX 77030 
 
 
 
 
 
 
 
 
 
 
 
Site #6 
Phillip Chang, MD 
 
 
 
University of Kentucky 
 
 
 
Department of Surgery 
 
 
 
 
 
800 Rose St., Office C243 
 
 
 
 
 
Lexington, KY 40536-0293 
 
 
 
 
 
 
Site #7 
Eileen Bulger, MD 
 
 
 
University of Washington  
 
 
 
Harborview Medical Center 
 
 
 
 
 
Department of Surgery 
 
 
 
 
 
325 9th Ave. 
 
 
 
 
 
Seattle, WA 98104 
 
 
 
 
 
 
Site #8 
Kent Choi, MD 
 
 
 
University of Iowa 
 
 
 
 
 
Department of Surgery – 1504 JCP 
 
 
 
 
 
200 Hawkins Dr. 
 
 
 
 
 
Iowa City, IA 52242 
 
 
 
 
 
 
 

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Site #9 
Thomas Carver, MD 
 
 
 
Medical College of Wisconsin 
 
 
 
 
 
Division of Trauma & Acute Care Surgery 
8701 W. Watertown Plank Rd. 
 
 
 
 
 
Milwaukee, WI 53226 
 
 
 
 
 
 
 
Site #10 
Demetrios Demetriades, MD 
 
 
 
Los Angeles County & USC Medical Center 
 
 
 
 
 
2051 Marengo St. 
IPT C5L100 
 
 
 
 
 
Los Angeles, CA 90033 
 
 
Site #11 
Joseph Minei, MD 
 
 
 
University of Texas Southwestern (UTSW) Medical Center 
 
 
 
5323 Harry Hines Blvd. 
 
 
 
Dallas, TX 75390-9158 
 
 
Site # 12 
Jay Johannigman, MD 
 
 
 
University of Cincinnati 
 
 
 
Division of Trauma/Critical Care 
 
 
 
Department of Surgery 
 
 
 
231 Albert Sabin Way 
 
 
 
Cincinnati, OH 45267-0558 
 
 
Site # 13 
Jose Diaz, MD 
 
 
 
University of Maryland  
 
 
 
22 S. Greene St., TBR07 
 
 
 
Baltimore, MD 21201-1595 
 
 
Site #14 
Jeffry Nahmias, MD 
 
 
 
Baystate Medical Center 
 
 
 
Surgery Research, S3613 
 
 
 
759 Chestnut St. 
 
 
 
Springfield, MA 01199 
 
 
Site #16 
Mark Muir, MD 
 
 
 
The University of Texas Health Center at San Antonio 
 
 
 
Division of Trauma and Emergency Surgery 
 
 
 
7703 Floyd Curl Dr., MC 7740 
 
 
 
San Antonio, TX 78229-3900 
 
 
Site #17 
Daniel Naughton, MD 
 
 
 
St. Louis University 
 
 
 
Department of Surgery 
 
 
 
3635 Vista Ave. 
 
 
 
St. Louis, MO 63110 
 
 

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Site #18 
Andrew Tang, MD 
 
 
 
University of Arizona 
 
 
 
Department of Surgery 
 
 
 
1501 N. Campbell Ave., Rm 5411 
 
 
 
Tucson, AZ 85724 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol CLP-01 Version 1.0; 9 December 2019        CONFIDENTIAL AND PROPRIETARY 
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PROTOCOL APPROVAL 
Protocol Number: CLP-01 
Protocol Title: An Independent Review of Safety Data from a Closed Clinical Study Using Irrisept 
(Protocol # IRR-CT-901-2013-01) 
Protocol Version: Version 1.0 
Protocol Date: 9 December 2019 
This protocol has been read and approved by: 
Sponsor: 
 
______________________________________________________________________ 
Name: Gerry Klein, MD, Chief Medical Officer 
 
 
Date: 
 
______________________________________________________________________ 
Name: Roger Morgan, MD, FASC Independent Medical Monitor Date: 
 
______________________________________________________________________ 
Name: Chevy Brown, MPH, CCRC, Clinical Trials Manager 
Date: 
 
______________________________________________________________________ 
Name: Christy Coleman, OD, MPH, VP Regulatory Affairs 
Date: 
 
 
 
 
 
 
12/11/2019
12/11/2019
12/11/2019
12/11/2019

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Retrospective Independent Safety Review of Closed Irrisept Study  
 
Protocol CLP-01 Version 1.0; 9 December 2019        CONFIDENTIAL AND PROPRIETARY 
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REVISION HISTORY  
Version 
Date 
Summary Description of Changes  
1.0  
9 December 2019 
Original 
 
 
 
 
 

IRRIMAX CORPORATION 
Retrospective Independent Safety Review of Closed Irrisept Study  
 
Protocol CLP-01 Version 1.0; 9 December 2019        CONFIDENTIAL AND PROPRIETARY 
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STATEMENT OF INVESTIGATOR COMPLIANCE 
This protocol is a retrospective review of existing safety data previously collected in a closed clinical 
study.  
I agree to: 
 
• 
Implement and conduct this study diligently and in strict compliance with the protocol, good clinical 
practices (GCP) and all applicable laws and regulations. 
• 
Maintain all information supplied by Irrimax in confidence and, when this information is submitted 
to an Institutional Review Board (IRB) or Ethics Committee (EC), it will be submitted with a 
designation that the material is confidential. 
• 
Comply with all IRB or EC requirements for this study.   
• 
Ensure that all personnel who have been delegated responsibilities for this study are trained on the 
protocol and adequately informed of their associated responsibilities prior to participation in this 
study. 
 
This document contains confidential information belonging to Irrimax Corporation, and therefore, may 
not be disclosed to any other person or entity without the prior written permission of the Sponsor 
unless such disclosure is required by law or regulation. 
 
Investigator Signature  
 
I have read and understand the contents of the clinical protocol including this Statement of Investigator 
Compliance.  I agree to follow and abide by the guidelines set forth in this document.  
 
 
 
 
 
 
 
Principal Investigator Name (print) 
 
 
 
 
 
 
 
 
 
 
 
 
  
Principal Investigator Signature   
 
 
 
Date  

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Retrospective Independent Safety Review of Closed Irrisept Study  
 
Protocol CLP-01 Version 1.0; 9 December 2019        CONFIDENTIAL AND PROPRIETARY 
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Table of Contents 
1.  
PROTOCOL SUMMARY ............................................................................................................. 9 
2. 
BACKGROUND INFORMATION ................................................................................................. 9 
3.  
STUDY OBJECTIVE .................................................................................................................. 11 
4.  
STUDY DESIGN ....................................................................................................................... 11 
5.  
STUDY POPULATION AND FOLLOW-UP ................................................................................. 11 
6.  
STUDY ENDPOINT .................................................................................................................. 11 
7.  
STUDY DATA PARAMETERS .................................................................................................... 12 
8.  
STATISTICAL ANALYSIS ........................................................................................................... 20 
9.  
DATA HANDLING .................................................................................................................... 20 
10.  
ETHICAL AND REGULATORY CONSIDERATIONS ..................................................................... 23 
11.  
SUBJECT DATA CONFIDENTIALITY .......................................................................................... 24 
12.  
RECORDKEEPING .................................................................................................................... 24 
13.  
CLOSE-OUT PROCEDURES ...................................................................................................... 24 
 
 

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1.  
PROTOCOL SUMMARY 
 
An Independent Review of Safety Data from a Closed Clinical Study Using Irrisept  
(Protocol # IRR-CT-901-2013-01) 
Study Type 
Retrospective Review  
Short Title 
Retrospective Independent Safety Review of Closed Irrisept Study 
Study Objective 
The objective of this retrospective review is to ensure that all safety data from 
the closed study have been accurately identified, verified and independently 
adjudicated.  The Sponsor will use the safety data from this review to complete a 
final study report and ensure the product risk assessment documentation is 
current and complete. 
Study Design 
Retrospective review of safety data previously collected in a closed randomized 
clinical trial (Protocol IRR-CT-901-2013-01) prospectively-conducted between 
2013 and 2016. 
Study Sites 
17 sites who originally participated and enrolled subjects in the closed study  
Study Population 625 subjects who were previously consented in the closed study.  
There is no new subject enrollment involved in this retrospective review.  The  
study population, including inclusion and exclusion criteria, was previously 
defined in the closed study protocol.  
Study Duration/ 
Follow-up 
There is no subject follow-up involved in this retrospective review.  The study 
duration and follow-up was previously defined in the closed study protocol. 
Key Study 
Parameters 
Preexisting safety data from the closed clinical study including all adverse events 
and any reports of device deficiencies. 
Key Study 
Endpoint 
As defined in the closed study Protocol IRR-CT-901-2013-01, this retrospective 
review will complete the safety endpoint analysis of adverse events associated 
with use of of Irrisept as compared to use of the Standard of Care for irrigation. 
 
2. 
BACKGROUND INFORMATION 
 
2.1 
Study Rationale 
Between 2013 and 2016, an Irrimax-sponsored prospective clinical study entitled, “A Phase IV, 
multicenter, prospective, randomized, controlled clinical study to compare the IrriSept system versus 
Standard of Care (SoC) on the prevalence of Surgical Site Infection (SSI) in patients with abdominal 
trauma or acute surgical abdomen”, IRR-CT-901-2013-01, was conducted in the United States under IRB 
approval.   A total of 19 sites were planned to participate in the study with only 17 sites enrolling 
subjects in the study, as listed above.   A total of 625 subjects were consented and 600 subjects were 
randomized (1:1) and received irrigation either with Irrisept or the Standard of Care.  Subjects were 
followed through study completion, and Protocol IRR-CT-901-2013-01 was previously closed with the 
IRBs.  However, the Contract Research Organization and Sponsor’s executive management responsible 

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for undertaking this study during that period of time (2013-2016) were unable to complete the 
necessary monitoring activities and final data reporting.   
In 2019, the Sponsor, under new management, intends to fulfill the Sponsor responsibilities by 
preparing a final study report for Protocol IRR-CT-901-2013-01.  Upon recent review of the previously 
reported safety data from this closed study, the Sponsor determined that remonitoring of the subjects’ 
source records is necessary to ensure complete and accurate reporting.  Furthermore, an independent 
review of the device-related safety data by a Medical Monitor is needed. 
Therefore, the Sponsor is initiating a retrospective review of the safety data, specifically all adverse 
events (AEs) and any device deficiencies that occurred in the closed clinical study based on the subjects’ 
source records, including identifying any events or deficiencies that may not have been previously 
reported on case report forms (CRFs).  The purpose of this retrospective review is to ensure all safety 
data on Irrisept are known and the product risk assessment documentation is current.   All reported AEs 
will be assessed by an independent Medical Monitor.  Device-related adverse events will be evaluated 
for any required reporting to regulatory authorities. 
The Sponsor does not intend to repeat the prospective clinical study IRR-CT-901-2013-01 or obtain any 
new information that was not previously collected in the subjects’ source records for the closed study.  
The Sponsor’s intent is solely to ensure all safety data are reported accurately and completely. This 
retrospective review will not recover or remonitor the previously reported efficacy data.   
The subjects who participated in the closed clinical study (IRR-CT-901-2013-01) have been consented 
and signed an informed consent form and authorization to use and disclose protected health 
information under the HIPAA Privacy Rule for that study.   As a retrospective review of subjects’ data 
previously collected under the closed study, there should be no need for any additional informed 
consent of the subjects for this review.   This review poses no risks to the previously enrolled subjects, 
and the subjects’ prior authorization to use and disclose protected health information remains in effect 
with only the Sponsor and the Contract Research Organization, working on behalf of the Sponsor, having 
access to review the subjects’ medical records to verify the accuracy of the safety data as reported on 
the CRFs. 
2.2 
Product Description  
In the closed clinical study (IRR-CT-901-2013-01), subjects were randomized to receive irrigation with 
Irrisept (study medical device) or with the Standard of Care , which was determined at the sole 
discretion of the Investigator or institution.  Refer to the U.S. Investigator’s Brochure for Irrisept Wound 
Debridment and Cleansing System for detailed product information and a report of prior investigations, 
including literature, pre-clinical and clinical studies. 
Irrisept® Wound Debridement and Cleansing System is an irrigation device comprised of a bottle of 
0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, USP and an applicator.  

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Irrisept is a wound cleansing delivery system with mechanical action that effectively loosens and 
removes wound debris. The CHG is a preservative to inhibit microbial growth in the solution.   
Irrisept is a prescription device and a combination product intended for use by healthcare professionals.  
Irrisept received 510(k) clearance (K080779) from the U.S. Food and Drug Administration (FDA) and has 
been marketed in the U.S. since 2009.    
This retrospective review is non-significant risk because the review involves only assessment of 
previously collected subject data.  This retrospective review does not involve any subject participation or 
use of any product. 
3.  
STUDY OBJECTIVE 
The objective of this retrospective review is to ensure that all safety data from the closed Irrisept study 
have been accurately and completely identified, verified and independently adjudicated. The Sponsor 
will use the safety data from this review to complete a final study report and ensure the product risk 
assessment documentation is current and complete.  
4.  
STUDY DESIGN 
This is a retrospective review of existing safety data from a prospective randomized clinical trial, 
conducted between 2013 and 2016, which was closed without a final clinical study report being issued.   
5.  
STUDY POPULATION AND FOLLOW-UP 
The study population, including inclusion and exclusion criteria, was defined in the closed study Protocol 
IRR-CT-901-2013-01.  The closed study protocol allowed for enrollment of up to 1,100 subjects.  At the 
17 sites who enrolled subjects in the closed study, 625 subjects were consented, 600 subjects were 
randomized and received irrigation with either Irrisept or the Standard of Care, and 450 subjects 
completed the study.  The study duration and follow-up schedule were previously defined in the closed 
study protocol.  The closed study involved two visits: Visit 1 included screening, peri-operative and post-
surgical; and Visit 2 was 30 days post-procedure. 
This retrospective review will include all 625 previously consented subjects from Protocol IRR-CT-901-
2013-01.  The review will assess for documentation of informed consent for these subjects, and the 
subjects’ source medical records will be reviewed for potential adverse events. There is no new subject 
enrollment or follow-up as part of this retrospective review.   
6.  
STUDY ENDPOINT 
The closed study Protocol IRR-CT-901-2013-01 defined primary and secondary efficacy, exploratory and 
safety endpoints. The previously defined safety endpoint from this closed study was a clinical review and 
analysis of adverse events.   

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This retrospective review is intended to complete the safety endpoint analysis of adverse events 
associated with use of of Irrisept or the Standard of Care for irrigation.  Note that this review does not 
include an evaluation of the efficacy or exploratory endpoints, as defined in the closed study Protocol 
IRR-CT-901-2013-01. 
7.  
STUDY DATA PARAMETERS  
The study data parameters are limited to the preexisting safety data from the closed study. This 
retrospective review involves identification, verification and adjudication of all adverse events in the 
study for all enrolled subjects based on the source medical records.  The adverse events will be 
summarized by group, type, severity and device-relatedness.  In addition, as part of the safety data 
review of the closed study, any device deficiencies with Irrisept documented in the source records 
during the closed study when the study device was used will be identified, even if the deficiency was not 
associated with an adverse event.  Any device deficiencies will be investigated to ensure the deficiency 
could not lead to an adverse event if the problem were to recur.  
7.1 
Safety Data Definitions 
All adverse events and device deficiencies as defined below will be recorded and verified based on the 
source documents from the closed clinical study.  The closed study (Protocol IRR-CT-901-2013-01) 
defined adverse events based on a combination of references (i.e., International Conference on 
Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) (1996), International Organization for 
Standardization (ISO) 14155:2011 standard, and 21 CFR Part 812).  For this retrospective review, the 
adverse event definitions are consistent with the closed study protocol; however, a few clarifications 
based on the ISO 14155:2011 standard have been described within these definitions.    
7.1.1 
Adverse Event 
As defined in Protocol IRR-CT-901-2013-01, an Adverse Event (AE) is any untoward medical occurrence 
in a subject or clinical investigation which does not necessarily have a causal relationship with the 
medical device under investigation.   
 
As described in ISO 14155, an adverse event includes: 
• 
events that are related or not related to the study device (Irrisept),  comparator (Standard of 
Care), or a study procedure; or  
• 
events in users or other persons that are related to the study medical device (Irrisept).  
Adverse events are categorized as serious or non-serious.  A non-serious adverse event is any event that 
does not meet the definition of serious adverse event, as listed below.   

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7.1.2 
Serious Adverse Event  
As defined in Protocol IRR-CT-901-2013-01, a Serious Adverse Event (SAE) is an adverse event that 
results in one of the following outcomes: requires hospitalization; prolongs hospitalization; is life-
threatening; results in congenital anomaly/birth defect; or results in death.  
Furthermore, as described in ISO 14155, a serious adverse event includes any adverse event that has led 
to a  serious deterioration in health that resulted in: 
• 
In-patient hospitalization or prolongation of existing hospitalization;  
o This criterion applies if the event requires in-patient hospitalization with an overnight 
stay in hospital or, if in the opinion of the Investigator, prolongs an existing 
hospitalization.  
o Hospitalizations for less than 24 hours with no admission are not considered 
“hospitalization”.  
o A planned hospitalization for a pre-existing condition (including for an elective 
procedure or routinely scheduled treatment) or a procedure required as part of the 
clinical study which has not worsened does not constitute an SAE. 
• 
Permanent impairment in body structure or function;  
• 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment of a body structure or function; 
• 
Is life-threatening; 
• 
Results in congenital anomaly/birth defect; or 
• 
Results in death. 
7.1.3 
Adverse Device Effect 
As defined in Protocol IRR-CT-901-2013-01, an Adverse Device Effect (ADE) is an adverse event that 
results from the presence or performance of the device or any component of the system.  
As described in ISO 14155, an adverse device effect includes any event resulting from: 
• 
Deployment, implantation or operation of the device 
• 
Malfunction of the device 
• 
Insufficient or inadequate instructions for use 
• 
Use error or intentional misuse of the device 
7.1.4 
Serious Adverse Device Effect 
As defined in Protocol IRR-CT-901-2013-01, a Serious Adverse Device Effect (SADE) is an adverse event 
related to the presence or performance of the device or any component of the system that results in 
one of the following outcomes: requires hospitalization; prolongs hospitalization; is life-threatening; 
results in congenital anomaly/birth defect; or results in death.  The same ISO 14155 clarifications as 
documented above for SAE also apply to SADE. 

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7.1.5 
Unanticipated Serious Adverse Device Effect 
As defined in Protocol IRR-CT-901-2013-01, a Unanticipated  Serious Adverse Device Effect (USADE) or 
Serious Unexpected Device Effect is any serious adverse effect on health or safety or any life- 
threatening problem or death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the investigational plan or 
application, or any other unanticipated serious problem associated with a device that related to the 
rights, safety, or welfare of subject.  
As described in ISO 14155, an unanticipated serious adverse device effect is an effect by which its 
nature, incidence, severity or outcome has not been identified in the risk analysis report, as documented 
in the following section. 
7.1.7 
Anticipated Adverse Device Effects Associated with Use of Irrisept 
Table 1 lists the potential risks associated with use of Irrisept based on the product risk analysis and the 
potential adverse device effects that are anticipated with these risks.  Potentially serious adverse device 
effects (anticipated SADE) have been assessed as a lower probability of occurrence. 
 
TABLE 1: POTENTIAL RISKS AND ANTICIPATED ADVERSE DEVICE EFFECTS FOR IRRISEPT 
Potential Risk  
Risk Assessment and Risk Mitigations 
Potential Anticipated Effects 
Allergic or 
anaphylactic 
response to CHG 
Potential for allergic reaction 
• 
Potential allergy to CHG is known to 
occur with other products containing 
CHG. However, serious allergic reaction 
is rare based on data published by the 
U.S. FDA on topical skin products 
containing CHG.1 
• 
Product is labeled as do not use in 
patients with CHG allergy. 
• 
A known CHG allergy was an exclusion 
criterion in the closed study protocol. 
- ADE: Minor non-serious 
allergic reaction (e.g., rash, 
dermatitis, itching, rhinitis) 
- SADE: Serious or life-
threatening allergic reaction 
requiring medical 
intervention (e.g., shortness 
of breath, tachycardia, 
tightness in throat, dizziness, 
anaphylactic reaction) 
                                                                
 
1 U.S. Food and Drug Administration website, “FDA Drug Safety Communication: FDA warns about rare but serious 
allergic reactions with the skin antiseptic chlorhexidine gluconate”; accessed September 2, 2016 at 
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-rare-
serious-allergic-reactions-skin-antiseptic  

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TABLE 1: POTENTIAL RISKS AND ANTICIPATED ADVERSE DEVICE EFFECTS FOR IRRISEPT 
Potential Risk  
Risk Assessment and Risk Mitigations 
Potential Anticipated Effects 
Exposure to bio-
incompatible 
material or 
chemical with 
potential for 
adverse tissue 
reaction  
Potential for toxicity reaction  
• 
Patient contact materials have passed 
biocompatibility testing per ISO standard 
10993-1. 
• 
Manufacturing process validations and 
quality control procedures have been 
completed to ensure product integrity 
and quality. 
- ADE: Minor tissue irritation, 
as manifested by symptoms 
such as pain, erythema, 
edema, itching, burning 
- SADE: Severe adverse tissue 
reaction that requires or 
prolongs hospitalization, or 
requires medical or surgical  
intervention to prevent 
permanent impairment 
 
Exposure to non-
sterile or 
contaminated 
product 
Potential for infection 
• 
Product is aseptically-filled and bottle 
and applicator surfaces are terminally 
sterilized.  
• 
Sterilization, packaging and 
manufacturing process validations have 
been completed to ensure product 
integrity and sterility. 
• 
Product contains CHG, which acts as a 
preservative to inhibit microbial growth I 
in the solution, and the product has 
been tested to show preservative 
effectiveness. 
• 
Bottle and applicator are sequentially 
double wrapped with CSR wrap serving 
as a microbial barrier. 
• 
Product has been tested to show 
stability and sterility are maintained over 
the labeled shelf life. 
• 
Surgical patients routinely receive 
antibiotics as part of the pre-op and 
post-op surgical care regimen since 
surgical site infection is a known 
complication of any surgery type. 
- ADE: Minor surgical site 
infection, wound infection or 
abscess, as manifested by 
symptoms such as erythema, 
edema, pus, fever, chills, pain 
- SADE: Severe infection that 
requires or prolongs 
hospitalization, or requires 
medical or surgical  
intervention to prevent 
permanent impairment 

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TABLE 1: POTENTIAL RISKS AND ANTICIPATED ADVERSE DEVICE EFFECTS FOR IRRISEPT 
Potential Risk  
Risk Assessment and Risk Mitigations 
Potential Anticipated Effects 
Use of product for 
irrigation affects 
wound healing 
Potential for delay in wound healing 
• 
Patient contact materials have passed 
biocompatibility testing per ISO standard 
10993-1. 
• 
Manufacturing process controls ensure 
product is not contaminated with any 
particulates from manufacturing. 
 
 
- ADE: Minor wound 
dehiscence,  non-healing 
wound, granuloma or 
adhesion 
- SADE: Severe wound 
dehiscence or non-healing 
wound that requires  or 
prolongs hospitalization, or 
requires medical or surgical  
intervention to prevent 
permanent impairment 
Ineffective use of 
product with 
inability to remove 
wound debris  
Potential for ineffective irrigation or 
incomplete irrigation 
• 
Surgeon routinely visually assesses 
surgical wound bed for effective 
debridement and clearance of 
particulates and wound debris. 
• 
Saline is routinely available for surgical 
irrigation in the event that the Irrisept 
bottle cannot be used. 
- 
ADE: Minor non-healing 
wound, granuloma,  
adhesion, adverse tissue 
reaction or infection 
- 
SADE: Severe non-healing 
wound, granuloma, 
adhesion, adverse tissue 
reaction or infection that 
requires or prolongs 
hospitalization, or requires 
medical or surgical  
intervention to prevent 
permanent impairment 
Incompatibility 
with other 
therapies used 
during the 
procedure 
Potential for incompatibility with other 
therapies (e.g., concomitant medications, 
other therapies used during surgery) 
• 
No known incompatible medications or 
therapies with Irrisept. 
• 
Irrisept is used an irrigation solution with 
short term exposure to the wound and 
surrounding tissues and is not ingested 
or injected. 
 
- 
ADE: Minor adverse tissue 
reaction  
- 
SADE: Severe adverse tissue 
reaction that requires  or 
prolongs hospitalization, or 
requires medical or surgical  
intervention to prevent 
permanent impairment 
 
7.1.8 
Device Deficiency   
A Device Deficiency is any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety and performance. Device deficiencies include malfunctions, use errors and inadequate 
labeling.   A device deficiency does not need to be related to an adverse event.  
 

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7.2 Safety Data Reporting 
7.2.1 
Safety Data Reporting Responsibilities 
 
The responsibilities for safety data reporting in this retrospective review are summarized below. 
- 
Investigator: The Investigator is responsible for recording all previously identified and newly 
identified adverse events and device deficiencies on the CRFs. Investigators must record on the 
source document and eCRF their opinion concerning the AE severity, relationship of the AE to 
device, seriousness categorization per the event definitions, and whether any device effect is 
anticipated or unanticipated.   The Investigator will follow all IRB/EC and institutional reporting 
requirements of AEs and SAEs, including for any new safety information or adverse events which 
may be identified retrospectively.  Investigators are required to prepare and submit complete, 
accurate and timely reports on this clinical investigation to the Sponsor, IRB/EC and/or regulatory 
authorities, when necessary. 
 
- 
Contract Research Organization (CRO): The CRO is responsible for source data review of AEs and 
device deficiencies.  As needed for monitoring activities, the CRO is responsible for appropriate 
follow-up with the Investigator, Sponsor and independent Medical Monitor, as per the study’s 
Medical Monitoring plan. The CRO is also responsible for data management of this retrospective 
review. 
- 
Medical Monitor:  Each AE will be assessed by an Independent Medical Monitor for severity, 
relatedness to the device, seriousness categorization per the event definitions, and whether any 
device effect is anticipated or unanticipated. A firewall will be established between the Sponsor and 
its CRO representatives, and the independent Medical Monitor to reduce bias in adjudication of AEs. 
- 
Sponsor:  The Sponsor will assess all adverse device effects determined to be related to Irrisept 
based on the independent adjudication of the Medical Monitor. The Sponsor will investigate any 
reported device deficiencies as part of the complaint handling process and to ensure the deficiency 
could not lead to an adverse event if the problem were to recur. The Sponsor is responsible for any 
required safety reporting to the FDA or other regulatory authorities, such as per 21 CFR 803 
(Medical Device Reporting), as applicable.   
7.2.2 
Specific Considerations for AE Reporting 
1. Abnormal Vital Signs and Laboratory Values 
Per Protocol IRR-CT-901-2013-01, it is the Investigator’s responsibility to review all vital sign findings 
or laboratory results for possible AEs. Medical and scientific judgment should be exercised in 
deciding whether an isolated vital sign or laboratory abnormality should be classified as an AE.  A 
vital sign or laboratory result should be reported as an AE if it meets any of the following criteria: 
• 
Results in a change in study product use (treatment interruption) 
• 
Clinically significant in the Investigator’s judgment 

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2. AEs Occurring Secondary to Other Events 
Per Protocol IRR-CT-901-2013-01, AEs occurring secondary to other events (e.g., cascade of events 
or clinical sequelae) should be identified by their primary cause, with the exception of severe or 
serious secondary events. However, medically significant AEs occurring secondary to an initiating 
event that are separated in time should be recorded as independent events. 
3. Persistent or Recurring AEs  
Per Protocol IRR-CT-901-2013-01, a persistent AE extends continuously, without resolution, 
between patient evaluation time points. Such events should only be recorded once on an AE CRF.  
 
A recurrent AE resolves between patient evaluation time points and subsequently recurs, and each 
recurrence should be recorded separately on an AE CRF. 
4. Use of Diagnosis for AE Reporting 
Whenever possible, diagnoses should be given when signs and symptoms are due to a common 
etiology. For example, cough, runny nose, sneezing, sore throat, and head congestion should be 
reported as “upper respiratory infection”.  
5. Preexisting Medical Conditions 
Per Protocol IRR-CT-901-2013-01, a preexisting medical condition is present at the screening visit for 
that study. Preexisting medical conditions should be recorded on the AE CRF. 
6. Deaths 
Per Protocol IRR-CT-901-2013-01, all deaths that occur during the study, regardless of relationship 
to the study device, must be recorded on the AE CRF. Death should be considered an outcome and 
not a distinct event. The event or condition that contributed to the fatal outcome should be 
recorded  on the AE CRF. The term “sudden death” should only be used for the occurrence of an 
abrupt and unexpected death due to presumed cardiac causes, pulmonary embolus (air embolus or 
fat embolus), or catastrophic stroke, in a patient without preexisting cardiac disease or history of TIA 
or stroke, within one hour of onset of acute symptoms, or in the case of unwitnessed death, within 
24 hours of when the patient was last seen alive and stable. 
7.2.3  AE Relationship to the Device 
The AE relationship to device will be determined by the Investigator and recorded on the AE eCRF. The 
independent Medical Monitor will provide for a separate adjudication on the Sponsor’s behalf for all 
identified AEs.  
Investigators should use their knowledge of the patient, the circumstances surrounding the event, and 
an evaluation of any alternative causes to determine whether or not an AE is considered to be related to 
the study device or Standard of Care. The following guidance should be taken into consideration: 
• 
Temporal relationship of event onset to the initiation of study device or Standard of Care 
• 
Course of the event, considering especially the effects of anesthesia and surgery 

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• 
Known association of the event with the study device/Standard of Care or with similar products 
• 
Known association of the event with the surgical interventions under study 
• 
Presence of risk factors in the patient or use of concomitant medications known to increase the 
occurrence of the event 
Device causality will be assessed as follows: 
- 
Unrelated: Concurrent illness, concurrent medication, or other known cause is clearly 
responsible for the AE; or based upon available information regarding subject history, a 
relationship between the device and AE is unlikely. If an AE is classified to be ‘unrelated’ then 
the suspected causality of the AE must be documented on the source and eCRF.  Causality can 
include AEs related to the surgical procedure, pre-existing conditions, or intercurrent 
conditions/intervention.  
- 
Unlikely Related:  Event or laboratory test abnormality, with a time of use of the device that 
makes a relationship improbable (but not impossible). Disease or use of other drugs and 
procedures may provide plausible explanations. 
- 
Possibly Related: The AE follows a reasonable sequence from the time of device use but could 
also have been produced by the subject’s clinical state or by other drugs or procedures 
administered to the subject.  
- 
Probably Related: The AE follows a reasonable sequence from the time of device use, and 
follows a known response pattern for use of the device.  The event is unlikely to be attributed to 
a disease or other drugs or procedures.   
- 
Definitely Related: The AE follows a reasonable sequence from the time of device use, follows a 
known response pattern for use of the device and no other reasonable cause exists.  
7.2.4  AE Severity 
The AE severity will be determined by the Investigator and recorded on the AE eCRF. AE severity will be 
scored as follows: 
GRADE 
DESCRIPTION 
0 
No AE (or within normal limits) 
1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
2 
Moderate; minimal, local, or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL) 
3 
Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care ADL 
4 
Life-threatening consequences; urgent intervention indicated 
5 
Death related to AE 

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8.  
STATISTICAL ANALYSIS  
The statistical analysis is summarized below. Further details of the analysis will be specified in the 
Statistical Analysis Plan (SAP). 
8.1 
AE Analysis 
AE rates will be summarized by type of AE, occurrence rate, severity and device-relatedness, as 
defined below. The summary tables will document the event descriptions, the total number of 
events, and the number and the percentage of subjects affected in each study group to inform the 
Sponsor’s product risk assessment. 
As documented in Protocol IRR-CT-901-2013-01, adverse events will be coded using MedDRA. AE 
summaries will be presented by study group using the MedDRA level hierarchy (system organ class, 
high level group term, high level term, and preferred term) as follows:  
• 
Overall (i.e., regardless of severity or relationship to treatment)  
• 
By severity grade   
• 
By relationship to study product according to the mapping scheme below:  
o Potentially related: will include all AEs with a relationship rating of “definitely”, 
“probably” or “possibly”.  
o Unlikely/not related: will include all AEs with a relationship rating of “unlikely” or 
“unrelated”. 
8.2 
Device Deficiency Analysis 
Device deficiencies will be summarized by type of deficiency and any relevant information about the 
deficiency. 
8.3 
Analysis Population 
The safety data will be analyzed for the Intent to Treat population of all subjects who were consented 
and randomized in the prior closed study protocol. Subjects will be categorized for analysis based on the 
actual irrigation product used during surgery (Irrisept or Standard of Care). 
9.  
DATA HANDLING 
 
9.1 
Data Collection and Reporting 
Data from the closed study were previously entered into an electronic data capture (EDC) system 
between 2013 and 2016.  New electronic case report forms (eCRFs) and a new database have been 
created for the retrospective review and clinical monitoring functions. All required data for this study 
will be collected on standardized eCRFs within a 21 CFR Part 11 compliant EDC system. 

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A new eCRF will be completed for all previously consented subjects indicating verification of informed 
consent and whether any adverse events or device deficiencies were identified in the closed study 
Source records. Any identified AEs will be entered on a new AE eCRF. Any identified device deficiencies 
will be entered on a new Device Deficiency eCRF. The data to be collected are summarized below. 
• 
For all subjects: 
o Verification of documentation of informed consent from closed study in the Source 
o Verification of signed and dated IRB-approved informed consent document 
o Verification of randomization and randomization assignment 
o Documentation of actual irrigation product used during closed study 
o Documentation of the subject’s medical diagnosis requiring open abdominal laparotomy as 
defined in the closed study eligibility criteria 
o Documentation of the reason for open abdominal laparotomy (e.g., trauma or acute surgical 
abdomen) 
o Description of the nature of trauma or acute surgical abdomen and what specific surgical 
procedures were performed 
o Verification of whether the subject experienced any adverse events in the closed study 
based on review of Source records 
o Verification of whether any device deficiencies were documented in the closed study Source 
records 
o Copy of redacted Source operative notes to provide relevant information for adjudication of 
any adverse events 
• 
For subjects who have an adverse event identified in the closed study Source records: 
 
 
o Dates of event report and when site became aware of event 
o Demographics (e.g., age, gender, race, weight, height) 
o Allergy, medical and surgical history 
o Concomitant medications taken 
o Adverse event term, type, description, onset date and timeline relative to device use, 
resolution date, outcome, severity and relationship to device 
o For serious events, criteria meeting SAE/SADE definition, dates of hospital admission and 
discharge, and/or date and cause of death, as applicable 
o Investigator’s medical opinion of likely cause of the event and device relationship 
o Description of device use during closed study, including any problems with the device or 
actions taken with the device as a result of the adverse event 
• 
For subjects who have a device deficiency related to Irrisept identified in the Source records: 
 
o Dates of report and verification Irrisept was used for irrigation in closed study 
o Description and nature of deficiency 
o Documentation of whether the deficiency was related to any adverse event 
o Investigator’s opinion if the deficiency could result in an adverse event if it were to recur 
 

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The Investigator or designee is responsible for completing, in a timely manner, an eCRF for each subject 
and all eCRFs for previously reported or newly detected AEs and device deficiencies.   The Investigator or 
designee is responsible for reviewing completed eCRFs to attest that all data entered are complete and 
accurate after the monitor finishes the source document verification process.  The Investigator is 
responsible for reviewing and signing each eCRF to indicate the Investigator has thoroughly inspected 
data and certifies its completeness and accuracy. 
 
9.2 
Monitoring Procedures 
 
Clinical site monitoring is conducted to ensure that the reported study safety data are accurate, 
complete, and verifiable. A Clinical Monitoring Plan will be developed by the CRO that details the 
retrospective chart review of existing safety data in the clinical study, IRR-CT-901-2013-01.   
Informed consent forms for all subjects who were previously consented in the clinical study, Protocol 
IRR-CT-901-2013-01, will be checked for proper recordkeeping and signatures  All subjects’ source 
medical records will be reviewed for any potential adverse events or device deficiencies. All identified 
AEs and device deficiencies in the Source medical records will undergo CRF review with 100% source 
data verification. Completed eCRFs will be verified by the monitor at the study site during the 
monitoring visit(s).   The clinical monitors will be unblinded as to the study randomization assignment.   
The study may also be subject to a quality assurance audit by the Sponsor and/or an inspection by 
regulatory authorities. It is important that the Investigator and relevant study personnel are available 
during on-site monitoring visits or audits and that sufficient time is devoted to the process. 
Separately, a Medical Monitoring Plan will be developed for this clinical study and will describe the 
process for reviewing and adjudicating all AEs. The independent Medical Monitor will be unblinded to 
the study randomization assignment.   
 
9.3 
Source Documents 
The Investigator must permit authorized representatives of the Sponsor and the IRB/EC to inspect 
facilities and original records relevant to this study. The study documents must be made available at 
reasonable times for inspection and duplication, if required, by a properly authorized representative of 
the U.S. FDA or other local or foreign regulatory authorities in accordance with regulatory requirements. 
The clinical monitors or auditors will check the eCRF entries against the source documents and inspect 
study files, subject medical records and other related study documents as required. These personnel will 
not disclose any protected health information.  
As described in the ICH GCP Guidelines and ISO 14155, ‘essential documents’, including eCRFs, source 
documents, previously collected informed consent forms, laboratory test results, and device records, 
should be retained by the Investigator for at least 2 years or in accordance with institutional procedures. 
The Investigator must obtain written permission from the Sponsor prior to the destruction of any study 
document.  

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Investigators should maintain information in the study subject’s medical records that corroborate data 
collected on the eCRFs.  To comply with these regulatory requirements, the following information will 
be maintained: 
• 
Medical history/physical condition of the study subject before involvement in the study 
sufficient to verify protocol entry criteria from the closed study protocol 
• 
Dated and signed notes on the day of entry into the study including the study investigator, study 
name, subject number assigned and a statement that consent was obtained 
• 
Information related to AEs and device deficiencies 
• 
Discharge summaries/procedure reports 
9.4 
Quality Assurance and Control 
Any missing data or data anomalies will be communicated to the site(s) for clarification/resolution.  
Following written CRO Standard Operating Procedures (SOPs), the monitors will verify that this 
retrospective review is conducted, and data are generated, documented and reported in compliance 
with the protocol, GCP, and the applicable regulatory requirements.   
9.5 
Protocol Amendments 
All protocols and amendments will be prepared by the Sponsor. If it becomes necessary to issue a 
protocol amendment during the course of the study, the Sponsor will notify the Investigators and collect 
documented Statement of Investigator Compliance to the amendment. 
10.  
ETHICAL AND REGULATORY CONSIDERATIONS 
The Sponsor and any third party (i.e., CRO) to whom aspects of the study management or monitoring 
have been delegated are committed to: compliance with the regulatory and IRB/EC requirements in the 
conduct of this retrospective study; ensuring Investigators are properly trained on study protocol and 
data collection procedures; monitoring the Investigators’ compliance; submitting timely required 
reports; and keeping Investigators informed. This study will be conducted in compliance with the study 
protocol, Good Clinical Practices (GCP), U.S. Code of Federal Regulations (CFR), ISO 14155 and the 
Declaration of Helsinki. 
Visits to Investigator sites will be conducted by the Sponsor or representatives of the Sponsor to inspect 
study data, subjects’ medical records and CRFs in accordance with current ICH GCP and the respective 
local and national government regulations.  Records and data may additionally be reviewed by auditors 
or by regulatory authorities.   
The Investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in ICH GCP and ISO 14155.  

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The protocol and any other study-specific documents shall be reviewed and approved by the 
appropriate IRB/EC prior to any retrospective data collection. Continued written approval must be 
obtained from the IRB/EC, as applicable according to regional and local requirements. Any updates to 
IRB/EC-approved documents may require re-approval before implementation of the changes. 
11.  
SUBJECT DATA CONFIDENTIALITY  
Subject confidentiality is strictly held in trust by the participating Investigators, their staff, the Sponsor 
and their representatives.  This confidentiality is extended to the clinical information relating to subjects 
previously enrolled in the closed clinical study (Protocol IRR-CT-901-2013-01).  Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence.  No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the Sponsor. 
12.  
RECORDKEEPING  
The Investigator will maintain records in accordance with ISO 14155 and ICH GCP: 
 
• 
Current and past versions of the IRB/EC-approvals 
• 
Current clinical protocol and current and past IRB/EC-approved consent form(s)  
• 
Any correspondence related to this protocol including with regulatory authorities (e.g., FDA)  
• 
IRB-related documentation: IRB membership list and/or assurance number, correspondence 
(including submissions and approval notifications), any safety or protocol deviation reports, and 
annual or interim reports 
• 
Signed Clinical Trial Agreement 
• 
Signed Investigator Agreements and financial disclosure forms for participating Investigators 
• 
Curriculum vitae (Investigator and Sub-Investigators) 
• 
Previously signed and dated informed consent forms 
• 
eCRF and Source Documents (laboratory and testing results, procedure reports, progress notes, 
physician and/or nursing notes, and subject office files, record of any complications, and/or AEs 
with supporting documentation) 
• 
Site Visit Log (for Monitor sign-in) 
• 
Monitoring confirmation and follow-up letters  
• 
Copies of relevant Sponsor-Investigator correspondence 
• 
Reports (includes AE reports and final reports from Investigator) 
13.  
CLOSE-OUT PROCEDURES 
Routine close-out activities will be conducted to ensure that each site’s records are complete, all 
documents needed for the Sponsor’s files are retrieved, all study data issues have been resolved, and all 
parties are notified.