Clinical trial NCT04756804
Conditions: Surgical Site Infection
Sponsor: Zurex Pharma, Inc.
Start date: 2021-06-21; Completion date: 2022-09-29
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.

Detailed description:

Arms: arm 1: 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation arm 2: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation
Interventions: intervention 1: 70% v/v Isopropyl Alcohol Surgical Solution intervention 2: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
Intervention descriptions: intervention 1: Patient preoperative skin preparation intervention 2: Patient preoperative skin preparation

Protocol documents:
Prot_000.pdf: 








Protocol Number: ZX-ZP-0113 
 
Zurex Pharma, Inc. 
Comparative Evaluation of Pre-op products  
 
 
Version 3: Date: 22Jun2021 
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Investigational Product, Dosage and Mode of Administration: 
 26-mL Applicator will be applied topically to the region of surgical incision using 
repeated back and forth strokes. For dry surgical sites such as the abdomen or arm, the product will be applied 
for a period of at least 30 seconds and for moist surgical sites (such as the inguinal fold) for 2 minutes. The 
application area should be allowed to air dry for approximately 3 minutes.  
Reference Therapy, Dosage and Mode of Administration: 
 will be applied according to the 
prescribing information. 
Duration of Study: Each patient will participate in the study for up to 51 days, including up to 21 days for 
screening  and 30-days of post-surgical follow-up for evidence of any SSI or other AEs. 
Criteria for Evaluation: 
Primary Efficacy Endpoint: The primary efficacy endpoint is the occurrence of any SSI within 30 days after 
surgery. A secondary analysis of the primary efficacy endpoint are subgroup analyses including: 
• 
Different types of SSI classified as superficial incisional infection, deep incisional infection, or organ-
space infection 
• 
Clean (class I wound) or clean-contaminated (class II wounds) surgeries 
Safety Endpoints: Safety endpoints will be analyzed over the entire treatment and follow-up period. 
• 
AEs (including local application site reactions and allergic reactions) 
Statistical Methods: 
Analysis Populations: The full analysis set includes all patients who were randomized to study treatment, 
received the study treatment, and underwent surgery. The per-protocol (PP) subset includes all full analysis set 
patients who had final follow-up at 30 days post-surgery. The safety subset will include all patients who were 
randomized to the study and received a study treatment and will be analyzed as they were treated. 
Statistical Analyses: All baseline data and efficacy and safety endpoints will be presented by descriptive 
statistics including numbers and percentages for categorical variables and mean, standard deviation (SD), 
median, minimum and maximum values for continuous variables. All data will be presented for all three of the 
analysis sets. 
AEs will be coded using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) 
preferred terms and will be grouped by system, organ, and class (SOC) designation. The severity, frequency, 
and relationship of AEs to investigational products will be presented by preferred term by SOC grouping. 
Listings of each individual AE including start date, stop date, severity, relationship, outcome, and duration will 
be provided. Each AE (based on preferred terminology) will be counted once only for a given study patient. If 
the same AE occurred on multiple occasions, the highest severity and relationship to investigational product 
will be assumed. Thus, study participants are not counted multiple times in a given numerator in the calculation 
of frequencies for a specific AE. The frequency and severity of skin irritation or allergic reactions at least 
possibly attributed to each product will also be presented. The number and percentage of patients who were 
prescribed prophylactic antibiotics and antibiotics to treat an infection as well as patient’s adherence to the 
 standard preop surgical instructions, will also be summarized. 


Protocol Number: ZX-ZP-0113 
 
Zurex Pharma, Inc. 
Comparative Evaluation of Pre-op products  
 
 
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Table of Contents 
1. 
Protocol Synopsis .................................................................................................................. 4 
2. 
List of Abbreviations and Definition of Terms ................................................................... 10 
3. 
Introduction ......................................................................................................................... 11 
3.1. 
Preventative Measures for Surgical Site Infections- Skin Preparation Agents ...... 12 
3.2. 
............................................................................................................ 12 
3.3. 
Risks and Benefits .................................................................................................. 13 
3.4. 
Safety of 
 ................................................................................................. 13 
4. 
Study Objectives .................................................................................................................. 14 
5. 
Investigational Plan ............................................................................................................. 14 
6. 
Study Interventions .............................................................................................................. 16 
6.1. 
Investigational Products ......................................................................................... 16 
6.2. 
Investigational Product Labeling and Storage ........................................................ 16 
6.3. 
Investigational Product Administration .................................................................. 16 
6.4. 
Investigational Product Accountability .................................................................. 17 
7. 
Study Procedures ................................................................................................................. 17 
7.1. 
Recruitment of Patients .......................................................................................... 17 
7.2. 
Eligibility Screening ............................................................................................... 17 
7.3. 
Selection of Patients ............................................................................................... 18 
7.3.1. Inclusion Criteria ....................................................................................... 18 
7.3.2. Exclusion Criteria ...................................................................................... 18 
7.4. 
Measures Taken to Minimize/Avoid Bias .............................................................. 18 
7.4.1. Randomization (Day 1) ............................................................................. 18 
7.4.2. Preoperative Surgical Instructions ............................................................. 19 
7.5. 
Interventions (Day 1) .............................................................................................. 19 
7.6. 
Assessments During the Inpatient Period ............................................................... 19 
7.7. 
Assessments During the Outpatient Period ............................................................ 19 
7.8. 
Telephone Assessments .......................................................................................... 19 
7.9. 
Duration of Patient Participation ............................................................................ 20 
7.10. 
Patient Withdrawal or Discontinuation Procedures ................................................ 20 
7.11. 
Study Termination Criteria ..................................................................................... 20 
7.12. 
Product Evaluation Survey ..................................................................................... 20 
8. 
Study Endpoints................................................................................................................... 20 
8.1. 
Efficacy Endpoints ................................................................................................. 20 
8.1.1. Primary Efficacy Endpoint ........................................................................ 20 
8.2. 
Safety Endpoints ..................................................................................................... 21 
9. 
Safety Monitoring Plan ........................................................................................................ 21 
10. 
Assessment Methods ........................................................................................................... 22 
10.1. 
Adverse Events and Serious Adverse Events ......................................................... 22 
10.1.1. Adverse Event Definition .......................................................................... 22 
10.1.2. Serious Adverse Events and Serious Unexpected Adverse Events 
Definition .................................................................................................. 22 
10.1.3. Methods/Timing for Assessing, Recording, and Analyzing Safety 
Endpoints ................................................................................................... 22 
10.1.4. Elicited Adverse Events ............................................................................ 23 


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Comparative Evaluation of Pre-op products  
 
 
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10.1.5. Classification of Adverse Event Severity and Relationship to 
Investigational Product .............................................................................. 23 
10.1.6. Outcomes and Actions Taken .................................................................... 24 
10.1.7. Reporting Serious Adverse Events ............................................................ 25 
10.1.7.1. 
24-hour Reporting Requirements (Initial Report) .................. 25 
10.1.7.2. 
3-Day Supporting Documentation Requirements .................. 25 
10.2. 
Demographics ......................................................................................................... 25 
10.3. 
Eligibility Checklist ................................................................................................ 26 
10.4. 
Locator Form .......................................................................................................... 26 
10.5. 
Medical History ...................................................................................................... 26 
10.6. 
Medications ............................................................................................................ 26 
10.7. 
Physical Examination ............................................................................................. 26 
10.8. 
SSI Diagnosis ......................................................................................................... 26 
10.9. 
MCW/Froedtert Hospital Standard Preoperative Surgical Skin Prep Instructions . 27 
10.10. Patient Disposition.................................................................................................. 27 
11. 
Statistical Methods and Determination of Sample Size ...................................................... 27 
11.1. 
General Approach ................................................................................................... 27 
11.2. 
Analysis Sets .......................................................................................................... 27 
11.3. 
SSI Rates ................................................................................................................ 27 
11.4. 
Antibiotic Use ......................................................................................................... 28 
11.5. 
Preoperative Surgical Skin Prep Instructions ......................................................... 28 
11.6. 
Safety Endpoints ..................................................................................................... 28 
11.6.1. Adverse Events .......................................................................................... 28 
11.7. 
Baseline Descriptive Statistics ............................................................................... 28 
12. 
Quality Control and Quality Assurance ............................................................................... 28 
12.1. 
Study Monitoring ................................................................................................... 29 
12.2. 
Audits and Inspections ........................................................................................... 29 
13. 
Ethics ................................................................................................................................... 29 
13.1. 
Institutional Review Board ..................................................................................... 29 
13.2. 
Review/Approval of Study Protocol ...................................................................... 29 
13.2.1. Protocol Modifications .............................................................................. 30 
13.2.2. Protocol Deviation Reporting Procedures ................................................. 30 
13.3. 
Ethical Conduct of the Study .................................................................................. 30 
13.3.1. Confidentiality ........................................................................................... 30 
13.3.1.1. 
Confidentiality of Data .......................................................... 30 
13.3.1.2. 
Confidentiality of Patient Records ......................................... 30 
13.3.2. Compensation for Participation ................................................................. 31 
13.3.3. Written Informed Consent ......................................................................... 31 
13.3.4. Delegation of Responsibilities and Adequate Resources .......................... 31 
13.3.5. Financial Disclosure .................................................................................. 31 
14. 
Data Handling and Record Keeping .................................................................................... 32 
14.1. 
Patient Identification and Confidentiality............................................................... 32 
14.2. 
Inspection of Records ............................................................................................. 32 
14.3. 
Retention of Records .............................................................................................. 32 
14.4. 
Trial Registration .................................................................................................... 33 
15. 
Final Report and Publication Policy .................................................................................... 33 
16. 
References ........................................................................................................................... 34 


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Appendix A. Wound Classifications ......................................................................................................... 36 
Appendix B. SSI Definitions .................................................................................................................... 37 
Appendix C. Patient Skin Antiseptic Preparation Clinical Trial Survey .................................................. 39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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List of Tables 
Table 1: 
List of Abbreviations and Definition of Terms ................................................................... 10 
Table 2: 
SSI Rates Post Surgery for Various Types of Surgeries ..................................................... 11 
Table 3: 
Schedule of Assessments ..................................................................................................... 15 
Table 4: 
Severity Rating Scale for Application Site Reactions ......................................................... 23 
 
List of Figures 
Figure 1: 
Example of 
 Label .......................................................................... 16 
 
 


Protocol Number: ZX-ZP-0113 
 
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Comparative Evaluation of Pre-op products  
 
 
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2. 
List of Abbreviations and Definition of Terms 
Table 1: 
List of Abbreviations and Definition of Terms 
Abbreviation 
Definition 
AE 
adverse event 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CFU 
colony forming units 
 
-mL Applicator  
cm 
centimeter 
eCRF 
electronic case report form 
EDMS 
electronic data management system 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HAI 
healthcare-associated infection 
HIPAA 
Health Insurance Portability Accountability Act 
ICH 
International Conference on Harmonization 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
IWRS 
interactive web-based randomization system 
MBC 
minimum bactericidal concentration 
MCW 
Medical College of Wisconsin 
MedDRA 
Medical Dictionary for Regulatory Activities 
MIC 
minimum inhibitory concentration 
mL 
milliliter 
NHSN 
National Healthcare Safety Network 
NNIS 
Nosocomial Infections Surveillance System 
PHI 
Protected Health Information 
PI 
principal investigator 
PP 
per-protocol 
preop 
preoperative 
PT 
preferred term 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SOC 
System, organ, class 
SSI 
surgical site infection 
US 
United States 
v/v 
volume/volume 
WHO 
World Health Organization 
w/v 
weight/volume 
 
  Solution Applicator 
Zurex 
Zurex Pharma, Inc. 














Protocol Number: ZX-ZP-0113 
 
Zurex Pharma, Inc. 
Comparative Evaluation of Pre-op products  
 
Version 2: Date: 15Apr2021 
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 Solution will be applied topically to the region of surgical incision using 
repeated back and forth strokes. For dry surgical sites such as the abdomen or arm, the product 
will be applied for a period of at least 30 seconds and for moist surgical sites (such as the 
inguinal fold) for 2 minutes. The application area should be allowed to air dry for approximately 
3 minutes. More than one applicator should be used if the coverage area exceeds 13.2 in x 13.2 
in (1126 cm2). 
will be applied topically to dry surgical sites (e.g., abdomen or arm) using gentle 
repeated back-and-forth strokes for a period of at least 30 seconds, then allowing the area to air 
dry for approximately 3 minutes. For moist surgical sites (e.g., inguinal fold), 
  will 
be applied using gentle repeated back-and-forth strokes for 2 minutes and allowing the area to air 
dry for approximately 3 minutes. More than one applicator should be used if the coverage area 
exceeds 13.2 in x 13.2 in (1126 cm2). 
6.4. 
Investigational Product Accountability 
Zurex requires Investigators to maintain accountability and adequate inventory security of the 
study material at all times. The Investigator or designee will: 
• Complete a Confirmation of Release and Receipt of Study Materials form upon 
receipt of the shipment and maintain and account for inventory on the Study Material 
Disposition form  
• Keep study materials in a secure storage area, accessible only to authorized 
individuals. 
• Dispense study material only to patients properly enrolled into the study. 
• Return all unused study materials to Zurex Pharma, Inc. at the end of the study or 
dispose of unused study materials as agreed upon. 
7. 
Study Procedures 
7.1. 
Recruitment of Patients 
Patients anticipating undergoing clean (class I wound) or clean-contaminated surgery (class 2 
wound) will be identified during chart review. See Appendix A for a description of wound 
classifications. If the potential participant is planning one of these procedures and otherwise 
appears to be eligible (e.g., ≥ 18 years old, no medical exclusions from chart review), the PI or 
designee will explain the study to the patient and if the patient is interested he/she will go 
through the informed consent procedure.  
7.2. 
Eligibility Screening 
Preliminary eligibility for study participation will be assessed as described above. If the patient 
appears to be an appropriate candidate for the study, a member of the study staff trained in 
human subjects’ protections will perform the informed consent process by explaining the nature 
and scope of the study and the potential risks and benefits of participation. The study will be 
explained to the potential subject in lay terms and in a quiet, private setting. Potential subjects 
will be given as much time and privacy as necessary to review the informed consent and ask any 




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stratified permuted block randomization procedure will be performed via an interactive web-
based randomization system (IWRS) with type of surgery [clean (class I wound) or clean-
contaminated (class II wounds) surgery]) as the stratification variable. 
If the patient is randomized and is never treated with one of the investigational products or never 
underwent surgery, then the patient will be considered a randomization failure and an additional 
patient will be randomized with the next randomization sequence at the time he/she is 
randomized. The reason(s) that a patient was considered a randomization failure or screen failure 
will be documented in source documents and eCRFs. 
7.4.2. 
Preoperative Surgical Instructions 
Each patient undergoing surgery at the MCW is instructed to shower with an antiseptic agent 
before the day of surgery. Additionally, the surgical staff follows standard preoperative surgical 
orders while prepping the patient for surgery. The patient will be asked about adherence to the 
instructions before surgery and the source documents will be checked for adherence to the 
standard preoperative surgical orders / activities the day of surgery.    
7.5. 
Interventions (Day 1) 
Patients will have the region surrounding the surgical site scrubbed with the assigned product as 
described in section 6.3. 
7.6. 
Assessments During the Inpatient Period 
During the post-surgical period while the patient is still in the hospital, the surgical site and 
surrounding area will be examined for signs of infection or other deep incisional infection and if 
evident, this will be recorded. Local skin reactions (erythema, rash, or pruritus) or other systemic 
allergic reactions to the investigational product will be recorded. Other AEs will be assessed by 
asking the patient an open ended question: How are you feeling? If any antibiotics are prescribed 
for prophylaxis or treatment of an AE, these will be reported. On the day of hospital discharge, 
all of the above assessments will also be performed. The patient will be given standard discharge 
instructions and a card with the name of study nurse or doctor to contact in the event of any post-
surgical complications. Patients will be scheduled for an examination appointment or possibly to 
come to the emergency room if any possibly serious complications have occurred.  
7.7. 
Assessments During the Outpatient Period 
If an outpatient follow-up visit has been scheduled, a physical examination should be performed 
including inspection of the surgical site for signs of an SSI and the skin at the application site for 
signs of an allergic reaction and new antibiotic prescriptions. Other AEs should be assessed with 
an open ended question and data will be recorded.  
7.8. 
Telephone Assessments 
Three-to-five days after hospital release, on study Day 30 or at any time a patient calls with a 
complaint, a telephone scripted interview will be completed that assesses AEs and the patient 
should be queried if they had any other doctor’s office visits that might be indicative of a post-
surgical problem indicative of an SSI or AE. If the patient cannot be contacted at Day 30, a 
person that they listed on the locator form should be called to determine if the patient died or is 




Protocol Number: ZX-ZP-0113 
 
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deep incisional infection (which involves fascia and muscle), or organ-space infection 
(which involves any organ or space other than the incised layer of body wall that was 
opened or manipulated during the operation) (definitions in accordance with CDC-
2019 will be used). 
• SSI rates by type of surgery including clean (class I wound) or clean-contaminated 
(class II wounds) surgeries 
8.2. 
Safety Endpoints 
Safety endpoints will be analyzed over the entire treatment and follow-up period. 
• AEs (including specifically local application site reactions and allergic reactions) 
9. 
Safety Monitoring Plan 
Safety monitoring will be conducted throughout the study; therefore safety concerns will be 
identified by continuous review of the data by the PI, clinic staff, clinical monitor, medical 
monitor, and Zurex. 
The IRB, Medical Monitor, PI, Clinical Monitors and Zurex will review any safety concerns 
throughout the trial. The roles of these individuals are described below. 
Medical Monitor: A Medical Monitor has been appointed for the study. The Medical Monitor 
will be available for making recommendations to the investigator and Zurex on the severity of 
any SAEs, and the relatedness to the study interventions. The Medical Monitor will also be 
responsible for tracking and assessing trends in the AEs reported. 
Clinical Monitors: The PI will allow representatives of Zurex to periodically monitor, at 
mutually convenient times during and after the study, all study data. These monitoring visits 
provide Zurex with the opportunity to evaluate the progress of the study and to obtain 
information about potential problems. The monitors will assure that submitted data are accurate 
and in agreement with any medical records or paper source documentation used; verify that 
investigational products are properly stored and accounted for, verify that patients’ consent for 
study participation has been properly obtained and documented, confirm that research subjects 
entered into the study meet inclusion and exclusion criteria, and assure that all essential 
documentation required by Good Clinical Practices (GCP) guidelines are appropriately filed. 
Monitors will conduct a site initiation visit prior to the start of the study. At this visit, they will 
assure that proper study-related documentation exists, assist in training investigators and other 
site personnel in study procedures and GCP guidelines, confirm receipt of study supplies, and 
assure that acceptable facilities are available to conduct the study. 
Routine monitoring visits by Zurex’s representatives will be scheduled at appropriate intervals 
but more frequently at the beginning of the study. At these visits, the monitors will verify that 
study procedures are being conducted according to the protocol guidelines, monitor eCRFs 
against source documents, review AEs and SAEs, and perform drug accountability. At the end of 
the study, they will confirm that the site has the appropriate essential documents on file, advise 
on storage of study records, and inspect the return and destruction records for unused 
investigational products. 


Protocol Number: ZX-ZP-0113 
 
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10. 
Assessment Methods 
All study assessments will be performed at the time points outlined in the Schedule of 
Assessments (Table 3) that is somewhat flexible due to different lengths of hospitalization after 
surgery and depending on the needs of the patient. The following sections outline the details and 
procedures associated with the assessments. All specified assessments will be recorded on a 
source document or the medical record and appropriate data will be transcribed into electronic 
case report forms (eCRFs). 
10.1. 
Adverse Events and Serious Adverse Events 
The investigator and study site staff are responsible for the detection, documentation, 
classification, reporting, and follow up of events meeting the definition of an AE or SAE. 
10.1.1. 
Adverse Event Definition 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product and may not necessarily have a causal relationship with 
the administered treatment. An AE can therefore be any unfavorable and unintended sign 
(including a clinically significant laboratory abnormality), symptom, or disease temporally 
associated with the use of an investigational product, whether or not related to the investigational 
product. Pre-existing conditions, diseases, or disorders are not considered AEs unless there is a 
change in severity or frequency. Planned surgeries will not be considered an AE. 
10.1.2. 
Serious Adverse Events and Serious Unexpected Adverse Events Definition 
An SAE is any untoward medical occurrence that meets one of the following: 
• Results in death 
• Is life-threatening (at the time of the event) 
• Requires inpatient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect 
A serious and unexpected AE is an SAE that is not identified in nature, intensity, or frequency in 
the risk information included in the Product Label for the drug. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse drug experience when, based upon 
appropriate medical judgment, they may jeopardize the study patient and may require medical or 
surgical intervention to prevent one of the outcomes listed in the definition. 
10.1.3. 
Methods/Timing for Assessing, Recording, and Analyzing Safety Endpoints 
AEs will be assessed starting after the first administration of investigational product until the 
final follow-up at Day 30. General symptoms will be collected via an open ended question: How 
have you been feeling since the last time we spoke? Elicited AEs will be assessed as described in 
section 10.1.4. 


Protocol Number: ZX-ZP-0113 
 
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AEs will be documented in the medical/source records, and recorded on the eCRF using 
accepted medical terms and/or the diagnoses that accurately characterize the event. When a 
diagnosis is known, the AE term recorded on the eCRF will be the diagnosis rather than a 
constellation of symptoms. The investigator will assess all AEs for seriousness, relationship to 
investigational product, and severity. When an event has not resolved by study closure, it will be 
documented on the AE CRF as “ongoing”. 
All AEs, including clinically significant abnormal findings on laboratory evaluations, regardless 
of severity, will be followed by study physicians until satisfactory resolution (the event either 
resolved or stabilized and is not expected to resolve in the near term). At the follow-up telephone 
contact, AEs will be recorded and followed to resolution only if they are serious, or if the study 
physician assesses them to be clinically significant. 
10.1.4. 
Elicited Adverse Events 
In addition to asked the open ended question regarding AEs, local application site reactions will 
be assessed by physical examination or querying the patient. These include the appearance of 
erythema or rash, or patient reported pruritus (itching). 
10.1.5. 
Classification of Adverse Event Severity and Relationship to Investigational 
Product 
For each recorded AE or SAE, a physician-investigator must make an assessment of severity 
according to the following criteria: 
Mild: 
An event that is usually transient, requiring no special treatment, and does 
not generally interfere with the patient’s daily activities. 
Moderate: 
An event that interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the 
patient. The event is usually ameliorated with additional specific 
therapeutic intervention. 
Severe: 
An event that interrupts usual activities of daily living or significantly 
affects clinical status. The event poses a significant risk of harm to the 
patient and hospitalization (prolonged) may be required, and typically 
requires intensive therapeutic intervention. 
Life-
threatening 
An event that puts the patient into imminent risk of death without 
intervention. 
The severity of application site reactions will be scored as shown in Table 4. 
Table 4: 
Severity Rating Scale for Application Site Reactions 
Reaction 
Grade 0 
Grade 1 - mild 
Grade 2 - moderate 
Grade 3 - severe 
Erythema 
None 
Target lesions 
covering <10% BSA
a and not associated 
with skin tenderness  
 
Target lesions covering 10 - 30% 
BSA and associated with skin 
tenderness  
 
Severe or medically 
significant but not 
immediately life-
threatening; IV intervention 
indicated  
 
 


Protocol Number: ZX-ZP-0113 
 
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Comparative Evaluation of Pre-op products  
 
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Reaction 
Grade 0 
Grade 1 - mild 
Grade 2 - moderate 
Grade 3 - severe 
Rash 
None 
Macules/papules 
covering <10% BSA 
with or without 
symptoms (e.g., 
pruritus, burning, 
tightness)  
 
Macules/papules covering 10 - 30% 
BSA with or without symptoms 
(e.g., pruritus, burning, tightness); 
limiting instrumental ADL; rash 
covering > 30% BSA with or 
without mild symptoms  
Macules/papules covering 
>30% BSA with moderate 
or severe symptoms; 
limiting self-care ADL  
 
Pruritus  
None 
Mild or localized; 
topical intervention 
indicated  
Widespread and intermittent; skin 
changes from scratching (e.g., 
edema, papulation, excoriations, 
lichenification, oozing/crusts); oral 
intervention indicated; limiting 
instrumental ADL  
Widespread and constant; 
limiting self-care ADL or 
sleep; systemic 
corticosteroid or 
immunosuppressive therapy 
indicated  
a Abbreviations: ADL = activities of daily living, BSA=body surface area. The above scale is taken from the 
National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. 
The investigator must make an assessment of relationship of the AE to the investigational 
product based on the following criteria: 
Unrelated: 
The patient did not receive the investigational product, the temporal 
sequence of the AE/SAE onset relative to administration of the 
investigational product is not reasonable, or there is another obvious cause of 
the AE/SAE. 
Unlikely: 
There is evidence of exposure to the investigational product but there is 
another more likely cause of the AE/SAE. 
Possible: 
There is evidence of exposure to the investigational product, the temporal 
sequence of the AE/SAE onset relative to administration of the 
investigational product is reasonable, but the AE/SAE could have been due 
to another equally likely cause. 
Probable: 
There is evidence of exposure to the investigational product, the temporal 
sequence of the AE/SAE onset relative to administration of the 
investigational product is reasonable, and the AE/SAE is more likely 
explained by the investigational product than by any other cause. 
Definite 
There is evidence of exposure to the investigational product, the temporal 
sequence of the AE/SAE onset relative to administration of the 
investigational product is reasonable, the AE/SAE is more likely explained 
by the investigational product than by any other cause, and the AE/SAE 
shows a pattern consistent with previous knowledge of the investigational 
product or investigational product class. 
10.1.6. 
Outcomes and Actions Taken 
For each recorded AE or SAE, the investigator must make an assessment of outcome at the time 
of last observation, as follows: 
Fatal: 
The patient died. 
Resolved without Sequelae: 
The AE or SAE has ended. 


Protocol Number: ZX-ZP-0113 
 
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Resolved with Sequelae: 
The AE or SAE has ended but changes are noted 
from baseline. 
Unresolved – Ongoing: 
The AE has not ended and is ongoing at the end of the 
reporting period or the investigator deems that further 
follow up is not medically required 
Unknown – Lost to Follow-up: 
Lost to follow-up at least 2 repeated, documented (15 
days apart) unsuccessful attempts to contact the 
patient. 
 
In addition, if the AE was treated (medications or other physical measures), this will also be 
recorded. 
10.1.7. 
Reporting Serious Adverse Events 
10.1.7.1. 24-hour Reporting Requirements (Initial Report) 
Any SAE, including death due to any cause, which occurs to any patient from the time of signing 
consent through the final follow-up telephone call whether or not related to the investigational 
product, must be reported within 24 hours of knowledge of the event by completing the AE/SAE 
eCRF. This will trigger an automatic notification of the SAE via an email communication to 
Zurex and 
. 
will notify the Medical Monitor upon receipt of the 
notification and coordinate communications with the Medical Monitor. 
10.1.7.2. 3-Day Supporting Documentation Requirements 
Written documentation for all SAEs must be received by  Zurex and 
 within 3 
business days of reporting the event. Required eCRFs that must be completed include the 
following: 
• AE/SAE eCRF (revised if additional information is available) 
In addition, scanned copies of the following may be requested to be uploaded to the data 
management system. 
• Copies of medical records/source documents pertinent to the event (laboratory 
reports, ECG tracings, medical chart notes, etc.). These should be identified only by 
Patient number and not include any patient identification information prohibited by 
Health Insurance Portability Accountability Act (HIPAA). 
• Any other relevant information necessary to support the investigator’s judgment 
regarding the SAE’s relatedness severity to the investigational product OR by request 
of the Medical Monitor/Alternate. 
These paper documents may be submitted by facsimile, as email attachments, or by attaching 
them to the patient’s eCRF casebook in the electronic data management system (EDMS). 
10.2. 
Demographics 
Demographics data include the patient’s age, gender, race, and ethnicity. These data will be 
collected by site staff on a source document and onto an eCRF. 


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10.3. 
Eligibility Checklist 
An Eligibility Checklist which includes all inclusion and exclusion criteria will be reviewed in 
after screening measures are completed and on the day of surgery prior to randomization on 
Study Day 1. If the patient is not eligible for the study, the reasons for ineligibility will be 
recorded on an eCRF. These patients will be considered screen failures. 
10.4. 
Locator Form 
After signing informed consent, patients will be asked to provide names, addresses, and phone 
numbers of several friends and/or family members who can be contacted if the patient cannot be 
located (Locator Form). This locator form will be used to assist in contacting patients after 
hospital discharge and at the final follow-up. This form asks patients his/her name, address, and 
phone number and to provide names, addresses, and phone numbers of several friends and family 
members who can be contacted if the patient cannot be located. This information is essential and 
will be collected during screening, and will be updated on the day of hospital discharge, if 
needed. This information will remain exclusively at the site.  
10.5. 
Medical History 
Medical history will be reviewed during screening to determine patient eligibility and also to 
record any past or current medical conditions including the reason for the planned surgery and 
the type of surgery that is anticipated. Any allergies to medications including 
, 
isopropyl alcohol, or other excipients in 
 Solution will also be recorded. 
Medical history findings will be reported on an eCRF. Childbearing potential in females and if 
currently breastfeeding will be recorded. Females of childbearing potential will have a pregnancy 
test. Pregnant or breastfeeding females will be excluded from the study. 
10.6. 
Medications 
Antibiotics taken up to 4 days prior to surgery or throughout the study until Day 30 will be 
recorded including the indication (i.e., prophylaxis or to treat an AE), start and stop dates, dose, 
route and frequency and will be reported on an eCRF. 
10.7. 
Physical Examination  
An appropriate pre-surgical physical examination will be conducted as part of screening and any 
relevant findings will be recorded. Post-surgical physical examinations will include signs of 
surgical site or other infection and other AEs such as local application site reactions (erythema, 
or rash). These data will be recorded on a medical record and an eCRF. 
10.8. 
SSI Diagnosis 
A study physician will evaluate the patient and medical records for evidence of SSI up to Day 
30. A determination of the type of SSI (Superficial Incisional SSI, Deep Incisional SSI, and 
Organ/Space SSI) will be made in accordance with CDC criteria as summarized in Appendix B. 


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10.9. 
MCW/Froedtert Hospital Standard Preoperative Surgical Skin Prep 
Instructions 
MCW/Froedtert Hospital has Standard Preoperative Surgical Skin Prep Instructions/Procedures 
for patients undergoing surgery that include use of an antiseptic agent before and/or the day of 
surgery. Additionally, the surgical pre-op staff follows standard preoperative surgical skin 
prepping orders the day of surgery. As per the MCW/Froedtert Hospital’s standard operating 
skin prepping procedures, this data will be recorded in the patients eCRF.  
10.10. 
Patient Disposition 
A patient disposition eCRF will be completed for all patients who are randomized to the study. 
This eCRF will be used to record the following data: 
1. Completion status: 
a. Patient completed full study (i.e., telephone contact was made at Day 30). 
b. Patient was lost to follow-up prior to Day 30. 
c. Patient died before Day 30. 
d. Patient withdrew consent to continued participation in the study prior to Day 30 (with 
reason if known). 
2. Date of release from the hospital 
11. 
Statistical Methods and Determination of Sample Size 
A formal statistical analysis plan (SAP) will be finalized prior to locking the database and 
commencing with the analysis.  
11.1. 
General Approach 
For descriptive purposes, dichotomous and categorical variables will be presented as number of 
observations and percentages; continuous variables will be given as means, standard deviations 
(SD), median, minimum (min) and maximum (max).  
All data will be presented in either a listing, summary table, or both. For summary descriptive 
statistics, missing data will be represented by counts, will be treated as missing at random, and 
no adjustments will be made. All statistical analyses will be performed using SAS version 
 
11.2. 
Analysis Sets 
The full analysis set includes all patients who were randomized to study treatment, received the 
study treatment, and underwent surgery. The per-protocol (PP) subset includes all full analysis 
set patients who had final follow-up at 30 days post-surgery. The safety subset will include all 
patients who were randomized to the study and received a study treatment and will be analyzed 
as they were treated. All analyses will be performed for each analysis set. 
11.3. 
SSI Rates 
The number and percentage of patients who were diagnosed with an SSI at any time post surgery 
will be presented to the full analysis set and the PP analysis set. The rates by type of SSI, 


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superficial incisional, deep incisional, and organ space will also be summarized. A listing will be 
provided by patient that includes these endpoints as well as the medical findings that contributed 
to each diagnosis as described in Appendix B. 
11.4. 
Antibiotic Use 
The number and percentage of patients who were prescribed prophylactic antibiotics and 
antibiotics to treat an infection will be summarized by treatment group for each analysis set. 
11.5. 
Preoperative Surgical Skin Prep Instructions  
The number of patients prepped following the MCW/Froedtert Hospital’s standard pre-operative 
skin prep procedures using a topical antiseptic agent will be summarized.  
11.6. 
Safety Endpoints 
11.6.1. 
Adverse Events 
AEs will be coded using the most recent version of the Medical Dictionary of Regulatory 
Activities (MedDRA) preferred terms and will be grouped by system, organ, and class (SOC) 
designation by treatment group. The severity, frequency, and relationship of AEs to 
investigational products will be presented by preferred term by SOC grouping. Listings of each 
individual AE including start date, stop date, severity, relationship, outcome, and duration will be 
provided. Each AE (based on preferred terminology) will be counted once only for a given study 
patient. If the same AE occurred on multiple occasions, the highest severity and relationship to 
investigational product will be assumed. Thus, study participants are not counted multiple times 
in a given numerator in the calculation of frequencies for a specific AE. The frequency and 
severity of skin irritation or allergic reactions at least possibly attributed to each product will also 
be presented.  
11.7. 
Baseline Descriptive Statistics 
Summaries of the characteristics of the patients and type of surgery performed in each of the 
study groups at baseline will be prepared for the full analysis set, PP analysis set, and safety 
analysis set.  
12. 
Quality Control and Quality Assurance 
This study will be conducted in compliance with this protocol, GCP including 45 CFR 160 and 
164 (Authorization for Use/Disclosure of Protected Health Information (PHI), 21 CFR 50 
(Protection of Human Subjects), 56 (Institutional Review Boards), 330 (Over-The-Counter 
Human Drugs which are generally recognized as safe and effective and not misbranded) and 
Tentative Final Monograph for Health Care Antiseptic Drug Products, ICH Harmonised 
Tripartite Guideline E6: Good Clinical Practice, the study protocol and any protocol 
amendments. 
Actions to ensure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate study center; the review of protocol procedures with the 
investigator and study personnel prior to study start; the design of suitable source documents 


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with appropriate instructions for use; the internal audit of source data according to GCP and 
internal procedures to ensure their accuracy, completeness, and verifiability; as well as the 
periodic site monitoring by the Sponsor’s representatives (clinical monitors). Clinical monitors 
will review medical records/source documents and eCRFs for accuracy and completeness during 
on-site monitoring visits; any discrepancies will be resolved with the investigator, as appropriate. 
Significant and/or repeated noncompliance will be investigated and remedial action instituted 
when appropriate. Failure to comply with remedial actions may result in study site termination 
and regulatory authority notification. 
12.1. 
Study Monitoring 
Study monitoring will be the responsibility of designated clinical monitors 
. 
Monitors will assure compliance with the clinical protocol and ICH GCPs, human subject’s 
protection, drug accountability, maintenance of the site regulatory file, and conformance of CRF 
data with source documents. Monitoring visits by clinical monitors will be scheduled to take 
place at the initiation of the study, during the study at appropriate intervals, and after the last 
patient has completed the study. A report of monitoring observations will be provided to the PI 
(for corrective actions) and the Sponsor. 
12.2. 
Audits and Inspections 
Authorized representatives of the Sponsor and the IRB may visit the site to perform audits or 
inspections, including source data verification. The purpose of the audit or inspection is to 
systematically and independently examine all study related activities and documents to 
determine whether these activities were conducted, and data were recorded, analyzed, and 
accurately reported according to the protocol, GCP guidelines, and any applicable regulatory 
requirements. 
The PI should contact Zurex Pharma if contacted by a regulatory agency about an inspection. 
13. 
Ethics 
13.1. 
Institutional Review Board 
The study will be conducted under a protocol reviewed by the local site IRB; the study is to be 
conducted by scientifically and medically qualified persons; the benefits of the study are in 
proportion to the risks; the rights and welfare of the subjects will be respected; the physicians 
conducting the study will ensure that the hazards do not outweigh the potential benefits; the 
results to be reported will be accurate; subjects will give their informed consent and will be 
competent to do so and not under duress; and all study staff will comply with the ethical 
principles in 21 Code of Federal Regulations (CFR) Parts 50 and 56 and the Belmont Principles. 
13.2. 
Review/Approval of Study Protocol 
Zurex Pharma is the IND holder for this product and will submit the protocol to its IND. The site 
must obtain written approval from the IRB to conduct the study before study initiation. Zurex 
Pharma will issue a formal authorization letter for the study to be initiated at the site. Progress 
reports will be submitted to the IRB by the Investigator at the frequency requested by the IRB. 


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13.2.1. 
Protocol Modifications 
All necessary protocol changes will be submitted in writing as protocol amendments to the IRB 
for approval prior to implementation. Zurex Pharma will submit all protocol amendments to the 
FDA. Protocol amendments will be approved by Zurex Pharma prior to IRB submission. 
13.2.2. 
Protocol Deviation Reporting Procedures 
All subject-specific deviations from the protocol are to be documented. The PI or designee will 
be responsible for identifying and reporting all deviations, which are occurrences involving a 
procedure that did not follow the study protocol. Any protocol deviation that adversely affects 
the safety or rights of a subject or scientific integrity of the study is considered a major deviation 
and will be reported immediately to the Zurex Pharma Project Manager and the local IRB. 
13.3. 
Ethical Conduct of the Study 
This study will be conducted in accordance with all applicable Federal human research 
protections requirements and the Belmont Principles of respect for persons, beneficence, and 
justice.  
The procedures set out in this study are designed to ensure that the sponsor’s representative and 
all study personnel abide by the principles of the ICH GCP Guideline and the CFR. The PI 
confirms this by signing this study protocol and Form FDA 1572. 
13.3.1. 
Confidentiality 
13.3.1.1. Confidentiality of Data 
Particular attention is drawn to the regulations promulgated by the FDA under the Freedom of 
Information Act providing, in part, that proprietary information furnished to clinical investigators 
and IRB will be kept confidential by the FDA only if maintained in confidence by the clinical 
investigator and IRB. 
By signing this protocol the investigator affirms to Zurex Pharma that information furnished to 
the investigator by Zurex Pharma will be maintained in confidence and such information will be 
divulged to the IRB or similar or expert committee; affiliated institution; and employees only 
under an appropriate understanding of confidentiality with such board or committee, affiliated 
institution and employees. 
13.3.1.2. Confidentiality of Patient Records 
To maintain patient confidentiality, all laboratory specimens, eCRFs, reports and other records 
will be identified by a patient number only. Research and clinical records will be stored in a 
locked cabinet. Only research staff, Zurex Pharma representatives, and 
 clinical 
monitors will have access to the records. Patient information will not be released without written 
permission, except as necessary for monitoring by representatives of Zurex Pharma. 
By signing the protocol, the investigator agrees that within local regulatory restrictions and 
ethical considerations, Zurex Pharma or any regulatory agency may consult and/or copy study 
documents in order to verify eCRF data. 


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13.3.2. 
Compensation for Participation 
There will be no compensation for patient participation in this study. 
13.3.3. 
Written Informed Consent 
The informed consent process and document will be reviewed and approved by the IRB and 
sponsor prior to initiation of the study. The consent document contains a full explanation of the 
possible risks, advantages, and alternate treatment options, and availability of treatment in the 
case of injury, in accordance with 21 CFR Part 50. The consent document indicates that by 
signature, the patient, permits access to relevant medical records by Zurex Pharma or designated 
clinical monitors. 
A written informed consent document, in compliance with 21 CFR Part 50, 32 CFR Part 219, 
and the Belmont Principles, and HIPAA Authorization will be signed by the patient before any 
study-related procedures are initiated for each patient. 
All potential subjects for the study will be given a current copy of the Informed Consent Form to 
read. All aspects of the study and informed consent will be explained in lay language to the 
patient by either the investigator, or a medically trained designee. Any patient who is unable to 
demonstrate understanding of the information contained in the informed consent will be 
excluded from study participation. 
All study patients will be given a copy of the signed informed consent. 
13.3.4. 
Delegation of Responsibilities and Adequate Resources 
The PI should have adequate time to conduct the study properly and should have an adequate 
number of qualified staff to assist with the conduct of the study. 
The term “investigator” used throughout this protocol refers to the PI and/or qualified 
sub-investigators. The PI may delegate responsibilities to other study site personnel. The PI shall 
delegate tasks only to individuals qualified by education, training, and experience to perform the 
delegated tasks. The PI shall have direct oversight of all delegated activities and shall document 
delegation of responsibilities. The PI is responsible for ensuring all delegated staff has been 
properly trained on the protocol and their assigned study responsibilities. A delegation log 
identifying all delegated duties and the individual to whom they have been delegated will be 
maintained at the study site.  
13.3.5. 
Financial Disclosure 
Clinical investigators are required to provide financial disclosure information for the submission 
of certification or disclosure statements required under 21 CFR § 54. As defined in 21 CFR § 
54.2, a clinical investigator is a listed or identified investigator or sub-investigator who is directly 
involved in the treatment or evaluation of research subjects. The term also includes the spouse 
and each dependent child of the investigator. In addition, investigators must promptly update 
financial disclosure information if any relevant changes occur during the course of the 
investigation and for 1 year following completion of the study. 


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14. 
Data Handling and Record Keeping 
Source documents include but are not limited to original documents, data and records such as 
hospital/medical records (including electronic health records), clinic charts, laboratory results, 
data recorded in automated instruments, and pharmacy records, etc. This study will use an 
EDMS 
) and eCRFs provided by 
. Data will be 
transcribed from source documentation into web-based eCRFs. The transcribed data will be 
consistent with the source documents or the discrepancies will be explained.  
Clinical monitors will review all source records and compare them to the data entered into the 
eCRF. All entries, corrections, and alterations will be made by the investigator or other 
authorized study personnel. Any errors identified during monitoring will have a query posted by 
monitor for site staff to address. The EDMS system maintains a full audit trail of data entry, data 
corrections, and data queries. 
14.1. 
Patient Identification and Confidentiality 
Patients will be identified on eCRFs by a unique patient number. No personal identifier will be 
used in any publication or communication used to support this research study. The patient 
number will be used if it becomes necessary to identify data specific to a single patient. The 
Sponsor and designated clinical monitors 
, the IRB, and the FDA are eligible to 
review medical and research records related to this study as a part of their responsibility to 
protect human subjects in clinical research. Personal identifiers will be removed from 
photocopied or electronic medical and research records. 
14.2. 
Inspection of Records 
The sponsor or designee will be allowed to visit the investigation facilities for the purpose of 
monitoring any aspect of the study. The investigator agrees to allow the monitor to inspect the 
investigational product storage area, investigational product stocks, investigational product 
accountability records, patient records, and other records relative to study conduct. 
Patients’ health information is used to report results of research to the sponsor and Federal 
regulators and may be reviewed during study audits for compliance with study plans, regulations, 
and research policies. The consent document indicates that by signature, the patient permits 
access to relevant medical records by the sponsor’s representative and by representatives of the 
FDA. 
Upon a patient’s termination from the trial, completed eCRFs will be ready and available for on-
site review by the clinical monitors at scheduled monitoring visits. 
14.3. 
Retention of Records 
The investigator is responsible for creating and/or maintaining all study documentation required 
by 21CFR Parts 50, 54, 56, and 312, ICH E6 section 8, as well as any other documentation 
defined in the protocol. The investigator must provide key documents to the sponsor prior to start 
of the study.  
Federal and local regulations require that the investigator retain a copy of all regulatory 
documents and records that support the data for this study for whichever of the following is the 
longest period of time: 


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• A period of 2 years following the final date of approval by the FDA or other regulatory 
agency of the study drug for the purposes that were the subject of the investigation; or 
• A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study drug for the purposes that 
were the subject of the investigation. 
The sponsor will notify investigators once one of the above 2 timeframes has been satisfied. 
If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 
following notification by the sponsor that the entire clinical investigation (not merely the 
investigator’s portion) is completed, terminated, or discontinued or 2 years following withdrawal 
of the Investigational New Drug application/Clinical Trial Authorization or request for 
marketing approval (New Drug Application/Marketing Authorization Application).  
If the investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. Study records should not be destroyed without consultation with the Sponsor. 
14.4. 
Trial Registration 
Zurex Pharma Inc. will register the trial on the National Library of Medicine’s Clinical Trials 
Registry on the World Wide Web at http://www.clinicaltrials.gov. 
15. 
Final Report and Publication Policy 
 will draft and prepare the final report with input provided from the PI and 
Infection Control Experts reviews and approval of the report. The final report will be a record of 
the total study conduct and will be subject to review by Zurex Pharma, Inc.  The final report will 
assess and summarize all data collected and include: test material identification, AE’s, 
randomization schedules, dates of study initiation and completion, and data demonstrating SSI 
outcomes. 
Manuscripts or presentations resulting from this study must be reviewed and approved by Zurex 
Pharma prior to publication. 
 






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Appendix A. 
Wound Classifications 
Classification  
Examples of Procedures  
Class I: Clean  
Risk of infection: ≤ 2%  
• Hernia repair  
• Mastectomy  
• Total hip or knee replacement  
• Vascular/cardiovascular procedures  
Class 2: Clean/Contaminated  
Risk of infection: 5-15%  
• Cholecystectomy (chronic inflammation)  
• Colectomy  
From: 
 
 


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Appendix B. 
SSI Definitions 
Superficial Incisional SSI 
Infection involves only skin and subcutaneous tissue of the incision 
AND 
Patient had at least one of the following: 
1. Purulent drainage from the superficial incision 
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the 
superficial incision 
3. Superficial incision that is deliberately opened by a surgeon, attending physician or other 
designee and is culture-positive or not cultured (note: a culture negative finding does not 
meet this criterion) 
AND 
Patient has a least one of the following signs of symptoms of infection: 
a. Pain or tenderness 
b. Localized swelling 
c. Redness 
d. Heat 
4. Diagnosis of superficial by a surgeon, attending physician or other designee 
Deep Incisional SSI 
Infection involves deep soft tissues if the incision (e,g., fascial and muscle layers) 
AND 
Patient has at least one of the following: 
1. Purulent drainage from the deep incision 
2. A deep incision that spontaneously dehisces or is deliberately opened by a surgeon, 
attending physician, or other designee and is culture-positive or not cultured (note: a 
culture negative finding does not meet this criterion) 
AND 
Patient has at least one of the following signs or symptoms: 
a. Fever > 38°C 
b. Localized pain or tenderness 
3. An abscess or other evidence of infection involving the deep incision that is detected on 
direct examination, during an invasive procedure, or by histopathologic or imaging test. 


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Organ/Space SSI 
Infection involves any part of the body, excluding the skin incision, fascia, or muscle layers, that 
is opened or manipulated during the operative procedure 
AND 
Patient has at least one of the following: 
1. Purulent drainage from a drain that is placed in the organ/space 
2. Organisms isolated from an aseptically obtained culture of fluid or tissue in the 
organ/space 
3. An abscess or other evidence of infection involving the organ/space that is detected on 
direct examination, during an invasive procedure, or by histopathologic examination or 
imaging test. 


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Appendix C. 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
   
  
  
  
  
  
 
 
 
 
 
  
   
  
  
  
  
  
 

SAP_001.pdf: 
NCT04756804




3 
1. 
ABBREVIATIONS............................................................................................................... 4 
2. 
INTRODUCTION................................................................................................................. 5 
3. 
PROTOCOL SUMMARY .................................................................................................... 5 
3.1. 
Study Objectives....................................................................................................... 5 
3.1.1. Primary Efficacy.......................................................................................... 5 
3.1.2. Primary Safety............................................................................................. 5 
3.2. 
Study Design ............................................................................................................ 5 
3.3. 
Study Endpoints ....................................................................................................... 9 
3.3.1. Primary Efficacy Endpoint .......................................................................... 9 
3.3.2. Safety Endpoints.......................................................................................... 9 
4. 
DEFINITION OF ANALYSIS SETS ................................................................................... 9 
5. 
HYPOTHESES TO BE TESTED ......................................................................................... 9 
6. 
SAMPLE SIZE CONSIDERATIONS .................................................................................. 9 
7. 
DATA QUALITY ASSURANCE ........................................................................................ 9 
8. 
STATISTICAL CONSIDERATIONS ................................................................................ 10 
8.1. 
General Considerations .......................................................................................... 10 
8.2. 
Participant Accountability and Protocol Deviations .............................................. 10 
8.3. 
Demographics and Surgical Characteristics ........................................................... 10 
8.4. 
Efficacy Analysis ................................................................................................... 10 
8.4.1. SSI Rates ................................................................................................... 10 
8.4.2. Antibiotic Use............................................................................................ 10 
8.4.3. Preoperative Surgical Skin Prep Instructions ............................................ 11 
8.5. 
Handling of Missing Data ...................................................................................... 11 
Missing Data will not be imputed. ...................................................................................... 11 
8.5.1. Missing Data within Dates ........................................................................ 11 
8.6. 
Safety Analysis ....................................................................................................... 11 
8.6.1. Adverse Events .......................................................................................... 11 
9. 
VALIDATION OF PROGRAMMING CODE ................................................................... 11 
10. 
TABLE, LISTING, AND FIGURE SHELLS ..................................................................... 12 


4 
1.
ABBREVIATIONS
Abbreviation
Definition
AE
adverse event
CDC
Centers for Disease Control and Prevention
CFR
Code of Federal Regulations
ChloraPrep®
ChloraPrep® Orange , 26-mL Applicator 
cm
centimeter
eCRF
electronic case report form
EDMS
electronic data management system
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability Accountability Act
ICH
International Conference on Harmonization
IND
Investigational New Drug
IRB
Institutional Review Board
MedDRA
Medical Dictionary for Regulatory Activities
mITT
modified intention-to-treat
mL
milliliter
PP
per-protocol
preop
preoperative
PT
preferred term
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SOC
System, organ, class
SSI
surgical site infection
US
United States
WHO
World Health Organization




6 
patients will be randomized with stratification by type of surgery (clean versus clean-
contaminated) in a 1:1 ratio to receive skin pretreatment with either 
 or 
 and 
will undergo surgery. The surgical site will be examined for signs of infection and local skin 
reactions at least once a day during hospitalization, and at discharge. The patient will be 
contacted by telephone approximately 3-to-5 days post hospital release and at 30-days post the 
day of surgery. During these telephone contacts, the patient will be asked about signs of local 
skin or systemic allergic reactions and a general question about how they are feeling to 
determine if any other AEs may have occurred. If during these queries, the patient reveals any 
events that may be indicative of an SSI, they will be asked to see a study doctor to determine if 
an SSI has occurred. If they have visited another doctor for an evaluation, the patient will be 
asked to provide any relevant medical records to include in the study files.  At any time after 
discharge up to 30 days post-surgery, the patient will be encouraged to call a study nurse or 
doctor and arrange for a prompt clinical evaluation if an infection is suspected. 
Study assessments and procedures will be performed at the visits and time points outlined in the 
Schedule of Assessments (Table 1).


7 
Table 1: 
Schedule of Assessments
Study Day
-21 to 1
2 – 30 if 
hospitalized 
(daily)
3 to 5 days 
post hospital 
release 
(telephone 
follow-up)
Outpatient 
follow-up visit 
– if conducted 
Any time patient reports 
possible SSI or clinician 
reports SSI and visits a 
doctor’s office or comes to the 
hospital or other clinic
30
(telephone 
follow-up)
Informed Consent
X 
Locator Form
X 
Medical History / Surgical Plan
X 
Physical Exam Per Standard of Carea
X 
X 
X 
X 
Prescribed antibiotics
X 
X 
X 
X 
X 
X 
Demographics
X 
Eligibility Checklistb
X 
Randomization, Treatment and 
Surgery
X 
Adherence to MCW standard preop 
surgical instructions
X 
AEs (open ended question) and elicited 
AE questionsc
X 
X 
X 
X 
X 
X 
SSI Evaluation
X 
X 
X 
X 
X 




9 
3.3.
Study Endpoints
3.3.1.
Primary Efficacy Endpoint 
The primary efficacy endpoint is the occurrence of any SSI within 30 days after surgery 
3.3.2.
Safety Endpoints
Safety endpoints will be analyzed over the entire treatment and follow-up period. 
x
AEs (including specifically local application site reactions and allergic reactions)
4.
DEFINITION OF ANALYSIS SETS
The study analysis populations will consist of the following: 
Full Analysis Set [modified intention-to-treat (mITT) analysis set: The mITT analysis set 
includes all patients who were randomized to study treatment, received the study treatment, and 
underwent surgery. Subjects will be analyzed by treatment received, not treatment randomized.
Safety Analysis Set: This is all patients that received study treatment. Patients are assigned to 
the treatment given, not randomized. If this set is different from mITT then it will be used in 
analysis and listings for adverse events  
Per Protocol Analysis Set: The per-protocol (PP) subset includes all full analysis set patients 
who had final follow-up at 30 days post-surgery.
5.
HYPOTHESES TO BE TESTED
This is a descriptive study. No hypothesis testing will be performed.
6.
SAMPLE SIZE CONSIDERATIONS
The sample size is a convenience sample of 200 subjects (100 subjects per treatment group). 
7.
DATA QUALITY ASSURANCE
Data quality assurance will start with training of clinical investigative staff on data collection and 
assessment procedures including a Manual of Operations that describes what data to collect and 
procedures for completion of eCRFs. Completed eCRFs will be reviewed by 
 clinical monitors on a regular basis throughout the trial by comparison against the 
source documents. 
All study data will come from the eCRFs and no other source data. eCRFs for this study were 
created using an electronic data management system (EDMS) 
).
eCRFs were created using an established data dictionary for each variable including the field 
name, field type, field attributes, and coding for variables. Range checks, alpha-numeric 
requirements, and null/not null parameters were programmed as applicable. Data entered into the 
EDMS system will be reviewed by 
 clinical monitors and data managers. If 




11
8.4.3.
Preoperative Surgical Skin Prep Instructions 
The number of patients prepped following the 
 standard pre-operative 
skin prep procedures using a topical antiseptic agent will be summarized. 
8.5.
Handling of Missing Data 
Missing Data will not be imputed. 
8.5.1.
Missing Data within Dates 
Missing dates are handled as follows: 
x
Missing day: The first day of the month will be used.  
x
Missing Month: The first month of the year will be used. 
Completely missing dates will remain missing, with no imputation applied. Consequently, time 
to onset and duration of such events will be missing. 
8.6.
Safety Analysis 
8.6.1.
Adverse Events
AEs will be coded using the most recent version of the MedDRA and will be grouped by SOC 
and preferred terms designation. The severity, frequency, and relationship of AEs to 
investigational product will be presented by SOC and preferred term groupings. Elicited AEs 
will be separately tabulated by treatment group. Listings of each individual AE including start 
date, stop date, severity, relationship, outcome, and duration will be provided. Each AE (based 
on preferred terminology) will be counted once only for a given study subject. If the same AE 
occurred on multiple occasions, the highest severity will be assumed. Thus, study subjects are 
not counted multiple times in a given numerator in the calculation of frequencies for a specific 
AE. 
9.
VALIDATION OF PROGRAMMING CODE
All SAS codes used to generate tables and listings will be validated and reviewed before being 
finalized. The validation process will be used to determine that the numbers are produced by a 
statistically valid method and that the execution of the computations is correct. Qualified 
personnel who have not previously been involved in the production of the original programming 
codes will perform the validation procedures. Methods of validation include independent 
programming and comparison to data listings. Tables will be reviewed for accuracy, consistency 
with this plan, consistency within tables, and consistency with corresponding output. Once 
validation is complete, a quality control reviewer will perform a final review of the documents 
for accuracy and consistency. Upon completion of validation and quality review procedures, all 
documentation will be collected and filed in the study documentation files 
.


12
10.
TABLE, LISTING, AND FIGURE SHELLS
List of Tables
Table 1: 
Subject Disposition - All Randomized Subjects .............................................................. 14 
Table 2: 
Demographic and Baseline Characteristics - mITT Subjects ............................................. 15 
Table 3: 
Demographic and Baseline Characteristics - PP Subjects ................................................... 16 
Table 4: 
Antibiotic Use Prior to Surgery – mITT Subjects .............................................................. 16 
Table 5: 
Antibiotic Use Prior to Surgery – PP Subjects .................................................................... 16 
Table 6: 
Surgery – mITT Subjects ..................................................................................................... 17 
Table 7: 
Surgery – PP Subjects ......................................................................................................... 17 
Table 8: 
Surgical Site Infection – mITT Subjects ............................................................................. 18 
Table 9: 
Surgical Site Infection – PP Subjects .................................................................................. 18 
Table 10: 
Type of SSI – SSI Subjects ................................................................................................. 18 
Table 11: 
Characteristics of SSI – SSI Subjects .................................................................................. 18 
Table 12: 
Antibiotic Use During and Post Surgery – mITT Subjects ................................................. 19 
Table 13: 
Antibiotic Use During and Post Surgery – PP Subjects ...................................................... 19 
Table 14: 
Overall Summary of Adverse Events – mITT Subjects ...................................................... 20 
Table 15: 
Number and Percentage of Subjects with Adverse Events - mITT Subjects...................... 21 
Table 16: 
Summary of Subjects with Adverse Events by Severity and Relationship – 
..... 22 
Table 17: 
Summary of Subjects with Adverse Events by Severity and Relationship – 
 ... 22 
Table 18: 
Number and Percentage of Subjects with Adverse Events by Maximum Severity - mITT 
Subjects ............................................................................................................................... 23 
Table 19: 
Number and Percentage of Subjects Adverse Events by Relatedness - mITT Subjects ...... 23 
Table 20: 
Number and Percentage of Subjects with Elicited Adverse Events by Maximum Severity - 
mITT Subjects ..................................................................................................................... 24 
Listings