Clinical trial NCT05919888
Conditions: Surgery Surgical Site Infection Cutibacterium Acnes Prosthetic-joint Infection
Keywords: Antimicrobial wound gel SURGX Betadine Dermal layer Skin preparation
Sponsor: St. Louis University
Start date: 2023-06-26; Completion date: 2023-11-14
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Detailed description:
Cutibacterium acnes (C. acnes) prosthetic joint infection is a devastating and somewhat unique complication to shoulder arthroplasty. It is a very slow-growing, aerotolerant anaerobic, non-spore forming, gram-positive rod-shaped bacteria that takes up to 2-3 weeks to grow in a lab setting. There have been several studies assessing various agents in the fight to prevent C. acnes prosthetic joint infection. These agents include standard peri-operative measures typically taken when performing shoulder replacement surgery - pre-operative prophylactic antibiotics, pre-operative skin cleanse/wash, topical adjuvants (povidone-iodine, chlorhexidine, etc.), and intra-operative antibiotic powders. The overall infection rate of shoulder arthroplasty has been cited to be between 0.9-2.9%, with C. acnes being the most common bacterium in shoulder arthroplasty periprosthetic infections. Morbidity and cost associated with shoulder prosthetic joint infection is extremely high, requiring multiple surgeries and months of treatment to overcome the infection.

One of the main issues with C. acnes is its preferred location within the body, residing within the sebaceous glands of the hair follicles, deep to the epidermis where many preoperative topical preparations to cleanse the skin prior to surgery have little affect. These glands are commonly found around the shoulder and upper back, and lead to acne. C. acnes, along with other common prosthetic joint infection bacteria, quickly create a biofilm which is impenetrable to most antibiotic agents, further stressing the importance of prevention. Recently there have been studies analyzing the effects of Benzoyl Peroxide (BPO) on C. acnes as it relates to shoulder arthroplasty in an attempt to reduce this bacterial burden prior to surgery. There have been promising results with multi-day preparation skin cleansing with benzoyl peroxide. However, there are no studies looking at intra-operative skin incision preparations targeting the region of skin where the C. acnes bacteria resides. In vitro studies show SURGX antimicrobial gel (Next Science, Jacksonville, FL) results in a marked reduction of C. acnes in addition to other common bacteria affecting prosthetic joints. This gel uses citric acid to chelate the metallic bonds of biofilm. The bacteria are then destroyed by a combination of a high osmolarity environment coupled with a surfactant.

The first purpose of the study is to evaluate if a dermal layer preparation will reduce positive cultures of C. acnes after primary shoulder arthroplasty. There will be a control group consisting of no skin preparation. There will be two additional comparative groups. The second purpose of this study is to compare the use of standard povidone-iodine swab versus SURGX antimicrobial gel as an application into the dermal layer after the skin incision has been made with a skin knife to see if there is a reduction in bacterial burden in the superficial and deep tissues at the end of a primary shoulder arthroplasty. Superficial and deep cultures will be obtained at the conclusion of the shoulder replacement surgery. These cultures will be held in the lab for 2 weeks to identify if bacteria is present. The study team's hypothesis is that the SURGX antimicrobial gel will provide a greater reduction in bacterial burden compared to povidone-iodine within the deep tissues after primary shoulder arthroplasty.

Arms: arm 1: All patients will receive standard pre-operative prophylactic antibiotics. Participants will all receive the same preoperative external skin preparation with Hibiclens (chlorhexidine) and ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl alcohol solution) prior to draping. Intra-operative irrigation will be standardized with Irrisept (chlorhexidine gluconate 0.05% in sterile water).

The control group will receive no dermal layer skin preparation. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with an agent. arm 2: At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with povidone-iodine.

Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once arm 3: At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with SURGX Wound Gel. SURGX wound gel is a topical antiseptic gel agent to be used on surgical incisions to prevent bacterial infection.
Interventions: intervention 1: Povidone-Iodine intervention 2: SURGX Wound Gel
Intervention descriptions: intervention 1: Applied to skin incision. intervention 2: Applied to skin incision.

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
 Date Printed: 10/09/2024
Personnel Information
1
Subject Population
4
Study Location
5
General Checklist
5
Funding
6
Expedited Paragraphs
7
Background, Purpose, Study Procedures
9
Radioisotopes or Radiation Machines
14
Devices
15
Drugs, Reagents, Chemicals, or Biologic Products
15
Other Levels Of Review
16
Subject Population
18
Subject Population
19
Risks
20
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
24
Potential Conflict of Interest
28
Informed Consent
29
Assent
30
HIPAA
31
Attachments
33
NCT05919888
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
NCT05919888
NCT05919888 May 7, 2024


 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
 Date Printed: 10/09/2024
PI Obligations
34
Event History
35


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SLU eIRB
1
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
------------------------------------------------------------------------------
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for
the prevention of bacterial seeding in total shoulder arthroplasty
Protocol Status:
APPROVED
Date Submitted:
04/16/2024
Approval Period:
05/07/2024-05/06/2025
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
* * * Personnel Information * * *
Study Personnel Roles:
-Principal Investigator: accepts responsibility for study, must sign obligations, can edit protocol and submit to IRB
-Administrative Contact: additional study contact, may or may not also be member of research team, can
edit/prepare protocol and submit to IRB
-Key Personnel (Research Team): SLU member of research team, can view protocol (not edit)
-Non-SLU Collaborator: member of research team from another institution or organization outside of SLU, has no
access to system, must be provided with PDF of protocol. NOTE: SLUH/SSM employees who collaborate
regularly may obtain a guest SLU account if access to system is needed.
-Department Chair: Official Department Chair, may or may not also be a member of research team, can view the
protocol (not edit). NOTE: a proxy may be listed if the Chair is the PI.
IMPORTANT NOTE: Human Subjects Protection Training is mandatory for all research team personnel.
Principal Investigator (PI)   Mandatory
PI must be SLU affiliate.
Name of Principal Investigator
(Faculty, Staff or Student)
Degree (MD/PhD)
Title
Otto, Randall
MD
Faculty/Staff
Email
Phone
Fax
randy.otto@health.slu.edu
3149147987
Department Name
 
 
Orthopaedic Surgery
 
 
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Y
Research Experience              *?HELP?*
15+ years of research as primary investigator and medical doctor with many publications, presentations, and
abstracts
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
X Perform study procedures or Specimen
Collection
6a.
X Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
X Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
X Subject Randomization or Registry
8.
X Collection of Subject Data


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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
9.
X Report Data (CRFs, e-CRFs, Spreadsheets)
10.
X Data Analysis
11a.
X Review Adverse Events
11b.
X Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
ottor
10-07-2018
Good Clinical Practice (GCP)
ottor
05-09-2006
CITI Biomedical Research Basic
Training
ottor
03-24-2022
COI - Needs review
 
Administrative Contact
Name of Administrative Contact
Degree
Title
Peterson, Asa
MD
Housestaff Resident
Ellenberg, Elie
MD
Faculty/Staff
Kaar, Scott
MD
Associate Professor
Gruender, Allison
RN
Research Nurse
Bijanki, Vinieth
MS
Research Scientist
 
 
 
Department Chair  Mandatory
The official Department Chair should be listed here. If the Department Chair is the PI, a proxy may be listed.
Name of Department Chair
Degree
Title
Place, Howard
MD
Professor
Email
Phone
Fax
place@slu.edu
(314) 977-4014
Department Name
 
 
Orthopaedic Surgery
 
 
Is this individual also a member of the research team?
N
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn't showing, upload a copy in the
Attachments section.
Research Experience      *?HELP?*
Research Team Member Duties Picklist


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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
1.
Recruitment
2.
Obtains consent
3.
Determine Subject Eligibility for Accrual
4a.
Subject Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
Perform study procedures or Specimen
Collection
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
6b.
Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
7.
Subject Randomization or Registry
8.
Collection of Subject Data
9.
Report Data (CRFs, e-CRFs, Spreadsheets)
10.
Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
place
12-12-2003
CITI/University of Miami Training
place
07-13-2022
COI - No further review needed
place
04-24-2001
Protecting Study Volunteers in
Research
place
02-13-2013
SLU Boot Camp Training
 
Research Team Roles
Name(s), Degree
Department
Experience
Duties
 Otto, Randall, MD
Orthopaedic Surgery
15+ years of research as
primary investigator and
medical doctor with many
publications, presentations,
and abstracts
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Administer
and/or Dispense Study
Drugs, Biologics or
Devices (must be
licensed), Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Peterson, Asa, MD
Graduate Medical
Education
10 years of research in the
biomedical field including
several first authorships
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Subject
Randomization or
Registry, Collection of


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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Ellenberg, Elie, MD
Graduate Medical
Education
Years of research
experience prior to and in
medical school
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Kaar, Scott, MD
Orthopaedic Surgery
Attending surgeon with
years of experience as a
Primary Investigator
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Perform study
procedures or Specimen
Collection, Administer
and/or Dispense Study
Drugs, Biologics or
Devices (must be
licensed), Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices  , Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis, Review Adverse
Events, Treat and Classify
Adverse Events
 Gruender, Allison, RN
Orthopaedic Surgery
Research experience
includes analysis and
evaluation of professional
research through higher
level education course
(Research in Advanced
Nursing Practice) completed
for MSN degree. Work
included literature reviews
and critical appraisals of
health-related research. All
clinical research activities
will be supervised.
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Receive, Store,
Manipulate or Account for
Study Drugs, Biologics or
Devices  , Subject
Randomization or
Registry, Collection of
Subject Data, Data
Analysis, Review Adverse
Events
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
 


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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Subject Population(s) Checklist
 
Select All That Apply :
X
Adults
Cognitively Impaired Subjects
Employees (specifically targeted)
Fetuses
Minors (under 18)
Neonates
Non English Speaking Subjects
Pregnant Women
Prisoners
Students (specifically targeted)
Terminally Ill Subjects
Wards of the State
Other (any population that is not specified above)
       
---------------------------------------------------------------------------------------------
* * * Study Location * * *
 
Study Location(s) Checklist
      
Indicate where the study will be conducted. Select all that apply:
Saint Louis University, Medical Center Campus
Saint Louis University, Frost Campus
Saint Louis University, Madrid Campus
Saint Louis University, SLUCare Practice Locations
X
SSM STL (DePaul Hospital, St. Mary's Health Center, St. Joseph (St. Charles, Wentzville, Lake Saint
Louis), St. Clare)
Cardinal Glennon Children's Medical Center
Saint Louis University Hospital (SSM Health- SLU Hospital)
SLU-SSM Cancer Center Research Alliance Sites
Other (In the box below, list any off-campus institutions or locations and describe the activities being
conducted there. Please provide letters of cooperation and/or IRB approvals from each location to
document support/approval of the study. You may provide such documentation as it becomes available, but
you may not begin work at those sites until documentation of support is provided to the IRB.)  Please refer
to the  Guidance for involving non-SLU institutions in human subject research.
      
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
 
General Checklist
      
Select All That Apply :


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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
X
Collection of Specimens
Data collection via e-mail or the Internet
Deception/Incomplete Disclosure
Dietary Supplements, Vitamins, and Other Food Agents
X
FDA Approved Device
X
FDA approved  drugs, reagents, other chemicals administered to subjects (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
X
Human blood, cells, tissues, or body fluids
International Research or Research on International Populations
Investigational drugs, reagents, chemicals, or biologic products
Investigational Device
X
Investigator Initiated Study     *?HELP?*
X
Medical Records
Photography, Video, or Voice-Recording Subjects
Questionnaires and/or tests
Radioisotopes/radiation-producing machines, even if standard of care
rDNA/Gene Transfer Therapy
Registry(ies)
Specimens to be stored for future research projects (must be in consent form)
Study of existing data or specimens
X
University Indemnified Study (SLU is responsible for liability coverage)    *?HELP?*
Other (clarify in text box to the right)
Single Use. Provide a brief summary and justification for the Single Use Therapy. Note: This application will
refer to research. For Single Use applications it is understood that 'research' will mean 'therapy'.
       
---------------------------------------------------------------------------------------------
* * * Funding * * *
 
Funding Checklist
 
NONE
 
 
 
Funding - Industry Sponsor


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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Sponsor Name
Sponsor's Protocol Version Date
Next Science
 
 
 
  
  
NOTE:   Applicable grant application, contract or subcontract, investigator's brochure, and sponsor's
protocol (for all industry sponsored clinical trials) must be attached. You will be prompted for these in
section #16 (Attachments).
---------------------------------------------------------------------------------------------
* * * Expedited Paragraphs * * *
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request
for Expedited Review.
 
To qualify for expedited review, research activities must (1) present no more than minimal risk to human subjects,
and (2) involve only procedures listed in one or more of the categories below.
 
 
 
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
 
a) 
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the
acceptability of the risks associated with the use of the product is not eligible for expedited review.)
 
        
    
 b)
Research on medical devices for which
(i) 
An investigational device exemption application (21 CFR Part 812) is not required; or
       
       
       
     
(ii) 
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
 
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
 
a) 
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts
drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently
than 2 times per week; or
 
     
     
   
      
From other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per
kg in an 8-week period and collection may not occur more frequently than 2 times per week.


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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
kg in an 8-week period and collection may not occur more frequently than 2 times per week.
    
Children are "persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which
the research will be conducted."
 
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
 
  
  
  
EXAMPLES: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or
if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a
need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected
either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor; (h) supra-and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by
buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
 
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
 
  
  
  
EXAMPLES: (a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subjects' privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiology; (e) moderate exercise,
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the
age, weight and health of the individual.
 
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE:
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects. 45CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
 
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
 
7.
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)


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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.
 
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new subjects;
(ii)
All subjects have completed all research-related interventions; and
(iii)
The research remains active only for the long term follow-up of subjects.
 
b)
Previously approved research where no subjects have been enrolled and no additional
risks have been identified.
 
c)
Previously approved research where the remaining research activities are limited to data
analysis.
 
9.
 [FOR IRB use only]. Continuing review or research not conducted under an investigational new drug
application or investigational drug exemption where expedited categories two (2) through eight (8) do
not apply but the IRB  has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been identified.
---------------------------------------------------------------------------------------------
* * * Background, Purpose, Study Procedures * * *
Title
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of bacterial seeding
in total shoulder arthroplasty
 
Complete Sections 1 - 16. In sections that allow reference to sponsor protocol or grant, clearly state section and
page numbers. Any information that is different or specific to the local site should be in the SLU application.
Specify N/A as appropriate.
1. Background
 
     Page numbers from a sponsor's protocol/grant may be referenced in 1a and 1b.
 
  
  
a)  
Provide an introduction and background information. Describe past experimental and/or clinical
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must
cite references in the response provided or attach a bibliography.     *?HELP?*
Cutibacterium acnes (C. acnes) prosthetic joint infection is a devastating and somewhat unique
complication to shoulder arthroplasty.  It is a very slow-growing, aerotolerant anaerobic, non-
spore forming, gram-positive rod-shaped bacteria that takes up to 2-3 weeks to grow in a lab
setting.  There have been several studies assessing various agents in the fight to prevent C.
acnes prosthetic joint infection.  These agents include standard peri-operative measures
typically taken when performing shoulder replacement surgery - pre-operative prophylactic
antibiotics, pre-operative skin cleanse/wash, topical adjuvants (povidone-iodine, chlorhexidine,
etc.), and intra-operative antibiotic powders.  The overall infection rate of shoulder arthroplasty
has been cited to be between 0.9-2.9%, with C. acnes being the most common bacterium in
shoulder arthroplasty periprosthetic infections.  Morbidity and cost associated with shoulder
prosthetic joint infection is extremely high, requiring multiple surgeries and months of treatment


Page 10 of 37
SLU eIRB
10
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
to overcome the infection.
One of the main issues with C. acnes is its preferred location within the body, residing within
the sebaceous glands of the hair follicles, deep to the epidermis where many preoperative
topical preparations to cleanse the skin prior to surgery have little affect. These glands are
commonly found around the shoulder and upper back, and lead to acne.  C. acnes, along with
other common prosthetic joint infection bacteria, quickly create a biofilm which is impenetrable
to most antibiotic agents, further stressing the importance of prevention.  Recently there have
been studies analyzing the effects of Benzoyl Peroxide (BPO) on C. acnes as it relates to
shoulder arthroplasty in an attempt to reduce this bacterial burden prior to surgery.  There have
been promising results with multi-day preparation skin cleansing with benzoyl peroxide.
However, there are no studies looking at intra-operative skin incision preparations targeting the
region of skin where the C. acnes bacteria resides.  In vitro studies show SURGX antimicrobial
gel (Next Science, Jasksonville, FL) results in a marked reduction of C. acnes in addition to
other common bacteria affecting prosthetic joints.  This gel uses citric acid to chelate the
metallic bonds of biofilm.  The bacteria are then destroyed by a combination of a high
osmolarity environment coupled with a surfactant.
The first purpose of the study is to evaluate if a dermal layer preparation will reduce positive
cultures of C. acnes after primary shoulder arthroplasty.  There will be a control group
consisting of no skin preparation.  There will be two additional comparative groups.  The
second purpose of this study is to compare the use of standard povidone-iodine swab versus
SURGX antimicrobial gel as an application into the dermal layer after the skin incision has been
made with a skin knife to see if there is a reduction in bacterial burden in the superficial and
deep tissues at the end of a primary shoulder arthroplasty.  Superficial and deep cultures will be
obtained at the conclusion of the shoulder replacement surgery.  These cultures will be held in
the lab for 2 weeks to identify if bacteria is present. Our hypothesis is that the SURGX
antimicrobial gel will provide a greater reduction in bacterial burden compared to povidone-
iodine within the deep tissues after primary shoulder arthroplasty.
 
Please save frequently
 
  
  
b)  
Describe any animal experimentation and findings leading to the formulation of the study, if
there is no supporting human data.
n/a
 
2. Purpose of the study
 
  
  
a)  
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary
shoulder replacement when using a no-prep control group versus antimicrobial wound gel
versus betadine applied to the skin layer after the skin incision has been made.  Reducing the
bacteria present in the deep tissues at the end of the surgery may prevent infections from
developing in the future.
 
     Page numbers from a sponsor's protocol/grant may be referenced in 2b and 2c.
 
  
  
b)  
List your research objectives (specific aims & hypotheses of the study).


Page 11 of 37
SLU eIRB
11
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Primary objective: skin incision preparation solution intraoperatively after the skin incision has
been made will reduce the number of positive cultures after primary shoulder arthroplasty
versus no intraoperative skin incision preparation.  A control group with standard preoperative
skin prep will be included.  All patients will receive standard of care preoperative antibiotics and
preoperative skin cleansing preparation prior to draping for surgery.
Hypothesis: the use of skin incision preparation solution will be more effective at reducing
positive cultures compared to the control group and the SURGX antimicrobial wound gel will
result in decreased C. acnes growth from intra-operative cultures when compared to the use of
povidone-iodine.
 
Please save frequently
 
  
  
c)  
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.). If the study is investigator-initiated, a timeline for individual subject
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be
randomized.
This is a prospective, sequential assignment study in which patients will be blinded to the
intervention.  Patients will be sequentially allocated based on enrollment ID number (alternating
consecutive fashion) with every third patient in the control group (no skin incision preparation)
beginning with patient #1.  The treatment group #1 (betadine) will be every third patient
beginning with patient #2.  Treatment group #2 (SURGX anti-microbial wound gel) will be every
third patient beginning with patient #3.
 
  
  
d)  
If subjects will be given placebo, please justify placebo use.    *?HELP?*
N/A
 
3. Study Procedures
 
    a)
N
Is this project a multicenter study (i.e., same project is conducted elsewhere by a
different investigator) OR does this study involve conduct of research at multiple sites?
      
Is SLU acting as a coordinating center for other sites OR is the SLU PI a direct recipient
of a federal grant for this research? If yes, complete and attach the  Supplemental
Application for Coordinating Center Activities.
      
Will the SLU site be participating in all parts/procedures/arms of the study?
   
    
    
If No, explain what SLU will NOT participate in:
 
Please save frequently
 
Page numbers from a sponsor's protocol/grant may be referenced in 3b, 3c, and 3d.
 
  
  
b)  
Describe all the procedures, from screening through end-of-study, that the human subject must
undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care. Specify which procedures are for research and
which are standard of care. Please note: The box below is for text only. If you would like to add


Page 12 of 37
SLU eIRB
12
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
tables, charts, etc., attach those files in the Attachment section (#16).
All patients must be undergoing a primary anatomic or reverse shoulder arthroplasty.  Patients
will be screened for iodine allergies and excluded from participation if they have this allergy.
Patients will be recruited and consented preoperatively in the office prior to surgery.  There is
no standard of care in regards to which topical incisional adjuvant is used, if any, in shoulder
arthroplasty.  Common agents that are frequently used for surgical preparation include
chlorhexidine and betadine (povidone-iodine).  No additional procedures will be required of the
study subjects.  All patients will receive standard pre-operative prophylactic antibiotics.  They
will all receive the same preoperative external skin preparation with Hibiclens (chlorhexadine)
and ChloraPrep (2% chlorhexadine gluconate / 70% isopropyl alcohol solution) prior to draping.
Intra-operative irrigation will be standardized with Irrisept (chlorhexidine gluconate 0.05% in
sterile water). At the time of the surgery, after the skin incision has been made with a skin knife,
the dermal layer will either be not prepped or be prepped with povidone-iodine (treatment group
1) or SURGX antimicrobial wound gel (treatment group 2).  At the conclusion of the case, five
total cultures will be obtained.  Two will be superficial and three will be deep cultures, one of
which will be an implant swab.  These cultures will be held in the lab for 2 weeks to evaluate for
Cutibacterium acnes.  After 2 weeks, we will evaluate the data to determine if there is a
difference in positive cultures between the two groups.  Our goal is 20 patients in each group
based on previous literature assessments of skin prep solutions prior to shoulder arthroplasty.
This will likely take 2-3 months to collect the appropriate number of patients and have the
complete 2 week results from the lab cultures.  The conclusion of the study is when we have
completed the number of patients (20) in each group and final 2 weeks lab results are final. We
will also collect information from medical records, as outlined in the data collection sheet.
 
  
  
c)  
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is
compared to a placebo group or comparison treatment group, what are the guidelines or
endpoints by which early decisions regarding efficacy or lack of efficacy can be made? For
example, it may be reasonable to stop enrollment on a study when efficacy has already been
clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated,
given the statistical power of the study as designed. Describe the guidelines that are in place to
assist in making these determinations, if relevant to the proposed study.
It has been reported in the literature that standard preoperative antibiotics and skin preparation
prior to draping for the surgery does not eliminate the presence of bacteria in the wound after
total shoulder arthroplasty.  It is not known if this will lead to an increased risk of infections long
term or if this is an incidental finding. No studies have looked at prepping the skin incision after
the incision has been made to reduce this potential bacterial burden.  Theoretically, if the
bacterial burden is reduced at the time of surgery, this may reduce the risk of late term infection
if it were to occur. The control group will receive standard pre-op skin cleansing. Since the
study endpoint is presence/absence of C. acnes in the cultures, and we only plan to enroll 60
patients, we do not expect to cease enrollment early.
 
  
  
d)  
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest group/unit for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide
references. For full board, unfunded studies describe sample size determination and power
analysis. If none, please justify.
Statistics will be run through standard statistical programs, involving analyses that compare two
groups of results - T-test, Chi-square etc.  Our decision of sample size is based upon the
literature with prior studies including comparative treatment groups of roughly 20 patients in
each arm.
 


Page 13 of 37
SLU eIRB
13
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Please save frequently
 
  
  
e)  
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If
so, describe the nature of the deception and provide a rationale for its use. Also, describe
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using
deception, an alteration of consent must be justified in the Informed Consent section of the
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section
(#16).  See IRB Deception Guidelines.
 
    f) 
Is there an accepted standard of care and/or standard practice at SLU for the
condition/disease/situation being studied? This information will assist in comparing
the risk/benefit ratio of study procedures relevant to usual care that would be
received outside of the research context. *?HELP?*
Y
 
    
  
   
If yes, please describe the standard of care and standard practice at SLU for the
condition/disease/situation being studied.
There is no standard of care in regards to skin/dermis preparation for shoulder arthroplasty at
SLU or in the field of shoulder replacement surgery.  Common skin/dermis preparations include
preoperative skin cleansers, betadine preparation, chlorhexidine skin preparation, and intra-
operative irrigation with various solutions. All patients will receive standard pre-operative
prophylactic antibiotics.  They will all receive the same preoperative skin preparation with
Hibiclens (chlorhexadine) and ChloraPrep (2% chlorhexadine gluconate / 70% isopropyl alcohol
solution) prior to draping.  Intra-operative irrigation will be standardized with Irrisept
(chlorhexidine gluconate 0.05% in sterile water).  During the study, the control group will not
receive a skin incision prep after the incision is made while the other treatment groups will
receive either povidone-iodine skin incision prep or SurgX gel prep.  We are only looking for the
presence of bacteria at the conclusion of the study.  It is not known if this bacteria is clinically
important but if present could potentially present as a late term infection.  These infections may
not present themselves for 2-10 years postoperatively.  The assessment in this study is to see if
this bacterial presence can be reduced after shoulder arthroplasty with the theoretical potential
advantage of reducing late term infections. Patients will have standard of care follow up
appointments with their physician which are typically at 2-weeks, 6-weeks, 3 months, 6 months,
and yearly (no end date) following shoulder arthroplasty. These are not part of the research
study.
 
   g) 
Does this study involve any diagnostic imaging, labwork or genetic testing that could
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could
include discovery that is expected (related to the research) or incidental (not related
to research aims, but possible, like a mass/shadow found in imaging despite not
looking for it).
Y
 
    
  
   
If yes, please describe and include whether there are plans to share findings with study
participants.
We will be collecting 5 cultures per patient.  These will included 2 superficial cultures and 3
deep cultures including one of the implant.  We will hold these cultures for 2 weeks to
determine the presence of Cutibacterium acnes.  This bacteria is commonly present after
shoulder replacement surgery (up to 73% of cases), although the clinical significance is not
known.  Presence of this bacteria does not mean that the patient will develop a clinical infection
or indicate that antibiotics are needed. The purpose of the study is to see if this bacterial burden
can be reduced for the potential reduction in the risk of late term infection if they were to occur.


Page 14 of 37
SLU eIRB
14
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
There are no plans to contact the patients as the results of these cultures would not have an
impact on their care. However, wound cultures obtained for the study will show up as lab results
in the patients’ medical records.
 
    h) 
Is this study subject to the NIH Genomic Data Sharing Policy?
The NIH GDS policy applies to all NIH-funded research that generates large-scale
human genomic data as well as the use of these data for subsequent research and
includes: genome-wide association studies (GWAS), single nucleotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
metagenomics, epigenomic and gene expression data, irrespective of NIH funding
mechanism. Click here for more specific examples.
N
 
---------------------------------------------------------------------------------------------
* * * Radioisotopes or Radiation Machines * * *
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes
information, please select the option to enable this section.
 
4.  Radioisotopes or Radiation Machines
 
In this section, investigators must enter all radiation usage associated with the protocol.
 
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA",
"Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases,
submission to the RSO/RSC should occur after the IRB staff has drafted the informed consent radiation exposure
risk statement, or verified the statement that was drafted by the research team (as noted below*).  For more
information on how to submit for radiation safety review, see RSC  instructions or contact the Radiation Safety
Officer at 977-6895.
 
(1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section,
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this
guidance.
 
 
a) 
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with
this protocol by clicking "Add" and adding to Table 1 below. (Includes X-ray, fluoroscopy, CT,
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife
procedures, etc.)
 
 
b)
 Total estimated research radiation dose * :
 
     
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures.


Page 15 of 37
SLU eIRB
15
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
 
 
*NOTE: Informed Consent Radiation Exposure Risk Statement- The appropriate Informed Consent Radiation
Exposure Risk Statement template language must be inserted into the SLU IRB Informed Consent, inclusive of
applying the total estimated research radiation dose specified in item b) from the table above, as instructed in the
SLU IRB Informed Consent Template. Per IRB Guidelines, the language will either be drafted by the IRB staff or
drafted by the research team and then verified by IRB staff prior to submission to the RSC for review. Contact the
IRB Office at 977-7744 or irb@slu.edu with any questions.
 
 
---------------------------------------------------------------------------------------------
* * * Devices * * *
5. Devices
 
 a) Please list in the space below all investigational devices to be used on subjects during this study.
 
 
 b) Please list in the space below all FDA approved devices to be used on subjects during this study.
 
FDA Approved Devices
Device Name
Manufacturer
Provide IDE #. Documentation
of IDE # required unless
imprinted on sponsor protocol
(attach in section #16).
SURGX Wound Gel
NextScience
---------------------------------------------------------------------------------------------
* * * Drugs, Reagents, Chemicals, or Biologic Products * * *
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents
Pilot
Phase I
Phase II
Phase III
Phase IV
X Not Phased
 
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not
need to be listed.
 
b)
Please list in the space below all investigational drugs, reagents or chemicals to be administered to
subjects during this study. Attach all applicable Investigator Brochures in section #16 (Attachments).


Page 16 of 37
SLU eIRB
16
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
 
c)
Please list in the space below all FDA approved drugs, reagents, chemicals to be administered to subjects
during this study. Attach all applicable package inserts in section #16 (Attachments).
 
FDA Approved Drugs, Reagents, Chemicals, Biologic Product
Drug Name
Manufacturer
Source (e.g., Pharmacy,
Sponsor, etc.)
Dosage
Povidone Iodine
Medline
Stocked on shelf
swabstick
 
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
 
 
 
---------------------------------------------------------------------------------------------
* * * Other Levels Of Review * * *
7. Other Levels Of Review
 
  
1. University Radiation Safety
  
Protocols that involve non-standard of care radioactive materials (which includes the terms
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET",
"MUGA", "Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-223",
"Y-90", etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety
Committee (RSC). For information on how to submit for radiation safety review, see RSC <a
href=https://www.slu.edu/research/faculty-resources/research-integrity-safety/documents/irb-protocols-
requiring-rsc-review-instructions-for-coordinators.pdf target=_blank > instructions or contact the
Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials
 
 
  
2. Institutional Biosafety
  
Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g.,
Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or
Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents
(including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection
Service (APHIS)) into one or more human research participants must be reviewed by the SLU Biological
Safety Officer. Most of these protocols also require review and approval by the SLU Institutional
Biosafety Committee (IBC). Please contact the SLU Biological Safety Officer at 977-6888 for more
information.


Page 17 of 37
SLU eIRB
17
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
X
Not Applicable
Yes, study requires Institutional Biosafety review
 
 
  
3. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee
  
Saint Louis University Hospital requires that all research involving the administration of medications
within the hospital (including outpatient areas such as the Emergency Department, Outpatient Center,
Saint Louis University Hospital-South Campus, etc.) be reviewed and approved by the Pharmacy,
Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that study drugs are received, stored,
prepared, and dispensed by the Hospital's Department of Pharmacy Services. Please contact the
Investigational Drug Services Clinical Pharmacist at 268-7156 or SLUH-IDS@ssmhealth.com for more
information.
X
Not Applicable
Yes, study requires PTNT review
 
 
  
4. Saint Louis University Hospital
  
All research involving Saint Louis University Hospital, including the Emergency Department, inpatient or
outpatient services (including outpatient surgery at SLUH South Campus and the infusion center at the
DOB) and medical record access, requires Research Business Review (RBR) and approval prior to
study initiation. This process is designed to facilitate compliance with state and federal regulations as
they pertain to research in hospitals and clinical research billing. While researchers can begin to
complete the SSM RBR form at any time, the form should not be submitted until the IRB and the Clinical
Trials Office (CTO) have approved the study. Please contact the Research Compliance Office at 577-
8113 or sluh-research@ssmhealth.com or the CTO at 977-6335 or clinical-trials-office@health.slu.edu
for more information.
X
Not Applicable
Yes, study requires Saint Louis University Hospital review
 
 
  
5. SSMSL
  
All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient
services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon
Research Business Review (RBR) prior to study initiation. This process is designed to facilitate
compliance with state and federal regulations as they pertain to research in hospitals and clinical
research billing. While researchers can begin to complete the SSM RBR form at any time, the form
should not be submitted until the IRB and the CTO have approved the study. Please contact the SSMSL
Office at 989-2058 or Marcy.Young@ssmhealth.com for more information.
Not Applicable
X
Yes, study requires RBR review
 
 


Page 18 of 37
SLU eIRB
18
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
6.
&nbsp&nbsp&nbspDoes this project require registration on ClinicalTrials.gov, and/or is
this project subject to the NIH GCP Training Requirement? (Select "Yes" if either apply)
Registration may be required if any of the following apply: 1) The project meets the
FDAAA definition of an "Applicable Clinical Trial", which requires registration on
ClinicalTrials.gov. 2) As of January 1, 2017, a new NIH policy mandated biomedical and
behavioral "Clinical Trials" to be registered on ClinicalTrials.gov. In addition, NIH policies
require personnel on NIH "Clinical Trials" to take GCP training every three years. 3)
Registering may be required for Journal Publication (ICMJE). Please review relevant
definitions here. Contact the CTO at clinical-trials-office@slu.edu with questions about
registering on ClinicalTrials.gov and refer to the training page of the IRB website for
information on NIH GCP Training requirements.
Y
 
 
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8.  Subject Population - In the space below, please detail the participants that you are requesting to recruit
(include description of each group requested)
a)
Expected age range of subjects. (For example ≥ 18 yrs to 90 yrs).
18 - 90 years of age
 
b)  
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all
sites under the direction of the SLU PI).
60
 
Exceeding the number listed here is a protocol violation. Prior IRB approval is required if additional
participants are to be accrued. If applicable, this number should be consistent with your power analysis
described in 3d.
 
c)  
Number of evaluable subjects to be accrued study wide.  *?HELP?*
60
 
d)
If including vulnerable populations (minors, pregnant women and fetuses, neonates, non-English speaking,
economically or educationally disadvantaged, prisoners, adults temporarily or permanently unable to
consent for themselves): 1) provide the rationale for the importance of including this population in the
research, and 2) specify the measures being taken to minimize risks to potentially vulnerable subjects.
Click on hyperlinks to access SLU Guidelines containing additional considerations and strategies for
mitigating risks.
n/a
 
e)
If women, minorities, or minors are not included, a clear compelling rationale must be provided unless not
applicable. Examples for not including minors: disease does not occur in children; drug or device would
interfere with normal growth and development; etc. If federally funded reference appropriate section of the
sponsors protocol/grant.  *?HELP?*
shoulder arthroplasty does not occur in children
 


Page 19 of 37
SLU eIRB
19
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
f) 
If any specifically targeted subjects are students, employees, or laboratory personnel, specify the measures
being taken to minimize the risks and the chance of harm to these potentially vulnerable subjects. See SLU
Guidelines for additional considerations and strategies for mitigating risks.
 
g)
Describe (labeled a-c): a) who you are recruiting for this study (e.g., your patients/students/colleagues,
those in existing database or registry, the general public), and b) how you are recruiting (flyers,
advertisements, direct call/mailing, membership networks, in-person recruitment in clinic, classroom, public
locations, etc.). For secondary data analysis or specimen studies, state how you have access to materials.
Importantly: do not contact participants prior to obtaining IRB approval for your study.
c) Also indicate whether or not you plan to obtain personal/private information or biospecimens for the
purpose of screening, recruiting, or determining eligibility of prospective subjects prior to obtaining informed
consent and how (obtained by communicating with prospective subjects or obtained by accessing records
or stored biospecimens). Note: if you are accessing medical records other than those of your own patients
or those in your immediate department, you will need to submit a <a href=
https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-
irb/irb_assets/prep_to_research_form.doc target=_blank>HIPAA Preparatory to Research form and submit
to the SLU Privacy Officer PRIOR to accessing records.
Please refer to the <a href=https://www.slu.edu/research/faculty-resources/research-integrity-
safety/institutional-review-board-irb/irb_assets/guidelines_subject_recruitment.doc target=_blank>SLU IRB
Recruitment Guidelines when designing recruitment strategies and upload recruitment materials to the
Attachments page for IRB review. You are expected to obtain permission for individuals/organizations that
assist with recruitment, and whenever possible, those assisting should share your materials with potential
participants on your behalf rather than providing you with private contact information.
a) adult patients of Dr. Otto and Dr. Kaar pursuing primary anatomic or reverse shoulder arthroplasty
b) in-person recruiting in clinic
c) Exclusion of patients will include any surgery other than primary anatomic or reverse shoulder
arthroplasty and patients with an iodine allergy
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
8. Subject Population (continued)
Page numbers from a sponsor's protocol/grant may be referenced in 8h.
 
h)
Inclusion and Exclusion Criteria.
 
 
  
Identify inclusion criteria.
Age 18-90 years of age
Undergoing elective primary anatomic or reverse shoulder arthroplasty
 
 
  
Identify exclusion criteria.
revision shoulder replacement surgery
patients with an allergy to iodine, benzalkonium chloride, or polyethylene glycol
 
i)
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Include provisions for prorating payment.


Page 20 of 37
SLU eIRB
20
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
n/a
 
j)
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
Next Science will cover the cost of the SURGX antimicrobial wound gel, betadine swabs, and laboratory
cost for the tissue wound cultures (300 total cultures)
 
k)
Estimate the probable duration of the entire study including data analysis and publication. This estimate
should include the total time each subject is to be involved and the duration the data about the subject is to
be collected. If the study is  Investigator-initiated, a timeline  for individual subject recruitment, follow-up,
total time for subject accrual, and data analysis for the study is required.
It will likely take 3-4 months to collect the appropriate number of patients per group.  Each patient will have
labs that will take 2 weeks for final results.  Data analysis after the final patients labs have returned will
take approximately 1 month.  Total study time to submission for publication should be no longer than 6
months.
 
---------------------------------------------------------------------------------------------
* * * Risks * * *
9. Risks
     
There is no research that can be considered totally risk free (e.g., a potential risk of breach of
confidentiality). Therefore, when describing the risk, the lowest level of risk is "no more than minimal risk".
 
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.1, 9.2, 9.3, and 9.4.
 
 
 
 
    1.
Use of investigational devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
 
 
 
 
 
    2.
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs with an
indication of frequency, severity and reversibility. This information can often be found in the
Investigator(s) brochure. NOTE: Include any likely adverse effects associated with placebos or
washout periods that subjects may experience while in the study.
 
 
 
 
 
    3.
Use of FDA approved drugs, reagents, chemicals, or biologic products.  Please include the clinical AEs
associated with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the package insert provided by the manufacturer. NOTE: Include any
likely adverse effects associated with placebos or washout periods that subjects may experience while
in the study.
Betadine (povidone-iodine): temporary skin irritation; potential for burning, itching, redness, blistering
in patients with an serious iodine allergy.  The frequency and severity are rare.  Reversibility can be


Page 21 of 37
SLU eIRB
21
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
accomplished with anti-allergy medication and local skin/wound care.
 
 
 
 
 
    4.
Use of FDA approved devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
There are reported side effects for SURGX antimicrobial wound gel including skin irritation, localized
burning and stinging.
 
 
 
 
 
    5.
Describe any risks related to performing study procedures. Please include all investigational, non-
investigational, and non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
The only potential risk would be an unknown risk of an allergy to iodine in the betadine group.  No
other risks will be incurred for the patient.
 
 
 
 
 
    6.
Describe any risks related to the use of radioisotopes/radiation-producing machines (e.g., X-rays, CT
scans, fluoroscopy).
 
 
 
 
 
    7.
Describe why this investigational compound/drug/device/procedure's risks/benefits are potentially
better than standard of care or other common alternatives. Any standard treatment that is being
withheld must be disclosed and the information must be included in the consent form. *?HELP?*
All patients will receive a standard and uniform preop skin prep and preop antibiotics.  The control
group will not receive a skin incision prep after the incision has been made.  The treatment groups will
receive either povidone-iodine or SurgX gel applied to the incision intraoperatively.  There is no known
risk between not receiving povidone-iodine versus SURGX wound gel incision skin prep. No standard
treatment is being withheld from any subject.
 
 
 
 
 
    8.
Describe any psychological, social, or legal risks the subject may experience.   *?HELP?*
n/a
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.9 and 9.10.
 
 
 
 
  
9.
Special Precautions. Describe the planned procedures for protecting against or minimizing potential
risks. If appropriate, include the standards for termination of the participation of the individual subject.
Discuss plans for ensuring necessary medical or professional intervention in the event of adverse
effects to the subjects.


Page 22 of 37
SLU eIRB
22
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
All analysis will be performed in HIPAA compliant manners.  The attending surgeon is prepared to
treat any associated adverse effect.  Anesthesiology will be on hand to help address any immediate
allergic reaction.
 
 
 
 
  
10.
Reproductive Risks.
 
 
 
    
   
a.
Please list the pregnancy category of any drugs or N/A.
n/a
 
           b. Please describe any reproductive risk associated with any part of the research study. Include any data
from other studies (animal or human).
n/a
 
11.
Data Safety Monitoring
 
 
 
 
          
Federal regulations require that when appropriate, the research protocol makes adequate provisions
for monitoring the data to ensure the safety of participants. Monitoring should be commensurate with
risks and with the size and complexity of the research, and could range from no plan needed to an
independent data safety monitoring board. Please refer to  SLU Guidelines for Data and Safety
Monitoring as you complete the questions below.
 
a.
Is there a Data Monitoring Committee (DMC) or Board (DSMB)?
N
 
 
 
 
 
          
If yes, please provide the following information (labeled a-g): a)  the composition of the board
(degrees/qualifications of members),  b)  whether the board is independent from the sponsor and
research team or not,  c)  frequency of meetings and issuance of reports to sites,  d)  assurance that
the board is reviewing aggregate safety data and making recommendations regarding study
continuance,  e)  provisions for ad hoc meetings if needed,  f)  who is reviewing SAEs in real time (MD
or DO), and  g)  stopping/halting rules (if any exist).
A DSM charter can be referenced for all items except for "f) who is reviewing SAEs in real time."
 
 
 
 
 
          
If no, please justify why not.
This is a single site study employing interventions that are not considered outside of the standard of
care. The trial involves the use of FDA approved agents in a manner that is not off-label.  The study is
not employing high-risk interventions and can safely be monitored by the PI and research team
members.
 
     
b.
  Is there a Data Safety Monitoring Plan (DSMP)?
Y


Page 23 of 37
SLU eIRB
23
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
 
 
 
 
          
Note, if all relevant plan information is included in DSMB question above, select 'Yes' and state "see
above" in the answer box.
 
 
 
 
 
          
If yes, provide details (labeled a-e) including: a) what types of data or events are captured and how are
they documented, b)  who is monitoring data, their independence/affiliation with the research and their
degrees/qualifications, c)  frequency of aggregate data review, d)  who is reviewing SAEs in real time
(MD or DO), and  e)  stopping/halting rules (if any exist).
a) Outcome and adverse event data will be collected by the research team and documented
electronically. Any AEs/SAEs observed will be collected on the date of the patient’s surgery by the
research team and reported to the PI. This would include any reaction to the application of the product
such as skin irritation, rash, or burning.  This would be treated at the time of surgery with irrigation of
the wound to flush the area and dilute the product.  If a severe case were to happen then steroid
medication would be administered.  There are no follow up appointments or study procedures after the
date of surgery included in the research study. AEs or SAEs will be recorded in a spreadsheet with
severity and causality noted. The spreadsheet will be kept on a SLU-managed computer with
encryption.
b) The data will be monitored by the PI and study team members. The PI, Dr. Otto, is an orthopaedic
surgeon familiar with the use of the products in the study. He also has 15+ years of research
experience. Other qualified team members include: Dr. Kaar, orthopaedic surgeon with years of
research experience, Dr. Ellenberg, orthopaedic surgery resident, and Dr. Peterson, orthopaedic
surgery resident.
c) Aggregate data will be reviewed after the first 20 participants have completed the study to detect
benefit, harm, or futility of the interventions in addition to any AE or SAE trends. Following this initial
review, the data will be analyzed every three months if the study continues longer than the expected
time frame of 3-4 months.
d) SAEs will be reviewed in real time by the PI (MD). The PI will ensure appropriate classification of
the event.
e) Because the study interventions are not considered outside the standard treatment, we do not
anticipate the need for stopping/halting rules that would differ from standard treatment of a patient
undergoing surgery.
 
 
 
 
 
          
If no, please justify why not.
 
   
12.
In case of international research (research outside of the U.S. or research on international
populations (non-U.S.)), describe qualifications/preparations that enable you to evaluate cultural
appropriateness and estimate/minimize risks to subjects. Include whether research is sensitive given
cultural norms.
 
 
 
    a.
State any local laws/regulations governing Human Subjects Research in the country(ies) you will
conduct the research and attach any relevant approvals. If none, state N/A.


Page 24 of 37
SLU eIRB
24
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
 
 
 
 
    b.
Will there be language barriers and if so, how will they be addressed?
 Note: If materials are to be distributed to subjects in their native language, please follow  SLU's
Guidance For Studies Involving Non-English Speaking Subjects.
 
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspNOTE: Export control laws include the transfer of
technical information and data, as well as information
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspand technology to foreign nationals. If this study
has international components, contact the  SLU Export
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspControl Officer for direction on whether export
control policies apply.
 
---------------------------------------------------------------------------------------------
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy * * *
10. Benefits/Alternatives
a)
Benefits. Describe the potential benefit(s) to be gained by the subjects and how the results of the study
may benefit future subjects and/or society in general.  Indicate if there is no direct benefit to the
participants.
It is known that bacteria (Cutibacterium acnes) is present in up to 73% of cases after shoulder arthroplasty
is performed.  It is not known if this bacteria will increase the risk of infection late term.  The goal of this
study is to see if this bacterial presence can be reduced by prepping the skin incision after it has been
made.  The potential benefit is that if the bacterial presence is reduced or eliminated by prepping the skin
incision (for those subjects in treatment groups), the potential development of late term infection may be
reduced. An individual subject may or may not benefit from participation in the study. Society may benefit
from the potential knowledge gained regarding skin incision preparation as a result of this study, improving
practices for patients undergoing shoulder arthroplasty.
 
b)
Alternatives. Describe any alternative treatments and procedures available to the subjects should they
choose not to participate in the study. If no such alternatives exist, please state that the alternative is
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be
applicable.
There is no standard skin preparation, the alternative would be nonparticipation.  Of note, povidone-iodine
and SurgX gel are available for all patients and is stocked on the shelf at the hospital.
 
11. Procedures to Maintain Confidentiality and Privacy
        
Federal regulations require that research materials be kept for a minimum of three (3) years and HIPAA
documents be kept for a minimum of six (6) years after the closure of the study. For FDA-regulated or
sponsored projects, the PI may be required to keep the data and documents for a longer time period.
 
Confidentiality
 
         To determine whether adequate provisions for confidentiality of data are in place, the IRB must ensure that


Page 25 of 37
SLU eIRB
25
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
research materials are stored in appropriate locations throughout the study (during collection,
transport/transmission, analysis and long term storage). Research information must be protected using
appropriate safeguards based on identifiability of the data and risk associated with the study (See SLU IRB
Confidentiality Guidelines).
     
For the questions below, please use the following definitions:
 Anonymous/De-identified: data contain no identifiers, including code numbers that investigators can link to
individual identities;
 Coded: data in which (1) identifying information, such as name or social security number, has been
replaced with a number, letter, symbol, or combination thereof (i.e., the code), and (2) a key to decipher the
code exists enabling linkage of data to identifying information (e.g., a master list), and (3) the key (master
list) is kept separately from coded data; AND/OR
 Identifiable: data that includes personal identifiers (e.g., name, social security number), such that
information could be readily connected to respective individuals.
 
 
a)
Electronic (Computer) Data
 
     
Click "Add" to enter data security information for each type of electronic data that will be created in the
study: anonymous/de-identified, coded, and/or identifiable (see definitions above).
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data. See the SLU ITS Sensitive Data Guide
for acceptable data security methods.
 
Not Applicable, No Electronic (Computer) Data
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Electronic Data
Type of Data
Storage Location
Data Transmission
Outside of SLU
Supplemental information
related to above items
can be entered here or
leave blank:
Coded
SLU ITS managed device
(computer, tablet, etc.)
with encryption
Not Applicable, I will not
be sending/sharing
electronic data outside of
SLU
b)
Hardcopy (Paper) Data
 


Page 26 of 37
SLU eIRB
26
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
     
Click "Add" to enter information for each type of hardcopy (paper) data that will be created in the study:
anonymous/de-identified, coded, and/or identifiable (see definitions above).
 To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data.
 
Not Applicable, No Hardcopy (Paper) Data
Study IRB-approved Prior to New Question (Question N/A- Grandfathered)
 
Hardcopy Data
Type of Data
Storage Location
Transported Data
Security
Supplemental information
related to above items
can be entered here or
leave blank:
Identifiable
SLU Locked Cabinet;
SLU Locked Room/Office
Personnel Supervision
Intra-operative culture
specimens will be stored
by a SLU laboratory until
final results are obtained,
then will be discarded per
lab protocol.  Hardcopy
consents will be stored in
SLU locked
cabinet/room/office under
personnel supervision
 
c)
If a master list is used in this study (linking study codes to subject identifiers), explain: a) how and where
you will secure the master list, b) how long it will be kept/when it will be destroyed, and c) provide a sample
of the code.
a) The master list will be a separate Excel sheet stored in a SLU-managed encrypted device on a secure T
drive. Only the research team will have access to the master list.
b) The list will be maintained until the study has ended and been published.
c) Participants will be coded 001, 002, 003, etc. and will be the only data sheet linked to patient identifiers.
The coded data collection sheet will contain this number and no patient identifiers.
 
d)
If data or specimens are being shared outside of the research team, indicate who will receive the material,
specifically what they will receive (data or specimens), and if an agreement has been signed to cover the
transfer. Note: unless covered under a Clinical Trial or other agreement, the transfer of data or specimens
to an external entity will require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) is used; for the transfer of data, a Data Use or Data Transfer Agreement is
used. Please contact the Research Innovation Group at 314-925-3027 for assistance.
No data will be shared outside of the study team including with the drug/device manufacturer.
 
 
e)
If samples or data will be provided to SLU from an outside source, indicate whether you will  have access


Page 27 of 37
SLU eIRB
27
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
to identifiers, and if so, how identifiable information is protected. Note: unless covered under another
agreement (e.g., Clinical Trial Agreement or subcontract), the transfer of data or specimens from an
external entity to SLU may require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) may be required; for the transfer of data, a Data Use or Data Transfer
Agreement may be required. Please contact the Research Innovation Group at 314-925-3027 for
assistance.
n/a
 
f)
If data will be collected via e-mail or the Internet, how will anonymity or confidentiality be affected?
Describe how  data will be recorded (i.e., will internet protocol (IP) addresses and/or e-mail addresses be
removed from data?).
 
g)
If you will be audio/video recording or photographing subjects, provide a rationale as voiceprints and
images of faces/unique body markings are considered identifiers.  Describe confidentiality procedures,
including any restricted access to images and/or the final disposition of the recordings/photos (destruction,
archiving, etc.).
 
h)
Describe any study-specific (non standard of care) information or documentation that will be put in the
participants' medical records for this research (e.g., study visit notes, lab results, etc.). If none, state "not
applicable". NOTE: documentation of research in Epic should be done in accordance with the SLUCare
Epic Research Charting Policy and Clinical Workflow: Documenting Research Encounters in Epic.
Wound cultures obtained for the study will show up as lab results in the patients’ medical records.
 
i)
Are there any information security requirements identified in the project's
RFP/Award Notice/Contract? This could include data security, technical
safeguards, security controls, NIST, FISMA, CFR, etc.
 If yes, SLU ITS approval is required. Contact InfoSecurityTeam@slu.edu to start
the approval process.
N
 
Privacy
 
 
Privacy refers to persons having control over the sharing of oneself with others.
 
j)   Please indicate how participant privacy will be protected in this study (select all that apply):
 
X
Discussion of health related and/or personal information in a private room/area
 
X
Research interactions/interventions are conducted in a private room/area
 
Use of drapes or other privacy measures
 
X
Collection of sensitive/identifiable information is limited to the minimum necessary to achieve


Page 28 of 37
SLU eIRB
28
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
the aims of the research
 
X
Access to study information is limited to the minimum amount of persons necessary to achieve
the aims of the research (e.g., access restricted to research team members only)
 
Consideration of parental inclusion/absence for studies involving minors
 
Other (please explain):
       
 
 
---------------------------------------------------------------------------------------------
* * * Potential Conflict of Interest * * *
12. Potential Conflict of Interest
  
    
Indicate whether you, your spouse or dependent children,  have, or anticipate having, any income
from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company
that owns/licenses the technology being studied. Please remember that you are responding for you
and any other investigator participating in the study. Financial Interest includes but is not limited to:
consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including
stock, stock options, warrants, partnership and other equitable ownership interests). For questions
regarding Conflict of Interest consult the  Conflict of Interest in Research Policy.
 
Check one of the following (please remember that you are responding for yourself, your spouse, dependent
children and any investigator, investigator's spouse and dependent children participating in the study):
 
1)
X
No equity interest and/or Financial Interest less than or equal to $5K
2)
Any equity interest and/or Financial Interest  exceeding $5K but not exceeding $25K in the past
year or expected in the current year
3)
Financial Interest  exceeding $25K in the past year or expected in the current year
 
Check all those that apply:
 
         
Consulting
         
Speaking Fees or Honoraria
         
Gifts
         
Licensing agreement or royalty income
         
Equity interests, (including stock, stock options, warrants, partnership or equitable ownership
interests), or serving on a scientific advisory board or board of directors
         
Other fees/compensation
 
 
       


Page 29 of 37
SLU eIRB
29
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the
following information:
 
1. 
A Conflict of Interest Management Plan.
            
has been approved for all investigators for this study
            
is pending
            
has not been initiated
 
2. 
Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for
each subcategory checked:
      
 
  Note to Investigator(s) Reporting a Potential Conflict of Interest
 
  Investigator(s) must have:
 
1.
Current, up-to-date Conflict of Interest Disclosure Form  on file with the SLU Conflict of Interest
in Research Committee (COIRC) that describes any financial relationship indicated above.
 
                  
.
This information must be disclosed on the SLU confidential Conflict of Interest
Disclosure Form and reviewed by the COIRC before accruing research subjects in this
study. If your current Disclosure Form does not contain this information, you are
required to submit an updated Disclosure Form to the COIRC.
 
2.
You may not begin your study until your disclosure form has been reviewed and any required
management plan has been approved by the COIRC for this study. To initiate COIRC review of
your study, please contact coi@slu.edu.
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
13. Informed Consent
 
Federal regulations require that informed consent be obtained from individuals prior to their participation in
research unless the IRB grants a waiver of consent. Answer the questions, below, then click Add to provide
the necessary consent documents and information regarding subject consent. Multiple consents/waivers
may be added, but they must be uploaded one at a time.
 
NOTE: You may refer to the SLU IRB Guidance for Obtaining Informed Consent for considerations
regarding the consent/assent process.
 
State N/A if not applicable.
 
  
  1)
How is consent being obtained? When and where will the discussion take place? If the study involves
a Non-English Speaking participant/population, please include details about plans for translated
consent materials and interpreters to be used (see SLU Guidelines for Involving Non-English


Page 30 of 37
SLU eIRB
30
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Speaking Subjects for more details).
Participants will be consented in person during clinic pre-operative clinic visit or the on the day of
surgery prior to surgery.
 
  
  2)
If the study involves adults unable to consent for themselves (whether diminished capacity to consent
is temporary, permanent, progressive or fluctuating), please address the following: a) how is capacity
to provide consent being assessed (initially and throughout study, if applicable); b) if unable to
provide consent, how is LAR being determined (See SLU LAR Guidelines); c) if unable to provide
consent, will assent be obtained and if not, why not?; d) if unable to provide assent, will dissent be
honored and if not, why not? Note: participants initially unable to provide consent for themselves are
expected to be given an opportunity to provide consent once capacity is gained. See SLU Guidelines
for Adults Unable to Provide Consent for additional detail.
n/a
Note: Any assent documents which will be used per the Adults Unable to Provide Consent guidance, should be
appropriately named and uploaded using the Add button and the Consent drop down menu selection.
 
Informed Consent
Title
Consent Type
Attached Date
Approved_CR2024_consent_form_V
ersion 2
Consent
09/12/2024
---------------------------------------------------------------------------------------------
* * * Assent * * *
14. Assent
     
Complete this section if your study includes minors. The Assent Form Templates (For
children and For adolescents) provide guidelines for writing the assent document.
 
     
 1.
Will minors be asked to give assent, then consent once they reach adulthood? If not, please justify. If
not capable to provide assent initially, please address whether assent will be obtained as the minor
gains capacity. Note: children who reach the age of adulthood during participation should be given
the opportunity to provide consent as parent/guardian consent no longer applies. If obtaining consent
would be impracticable (e.g., this is a registry with data/specimen obtained long ago), a waiver of
consent should be added for IRB review. See SLU Guidelines for Research Involving Minors for
additional detail.
 
     
 2.
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If
yes, justify.
 
     
 3.
How will the minor's ability to give assent be assessed? (Consider the age and maturity of the minors
as well as their physical or mental condition). If capacity is fluctuating, please explain how capacity
will be assessed throughout the study.


Page 31 of 37
SLU eIRB
31
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
  
Note:  For studies that require a discussion about reproductive risks, note that the conversation with the
minor should take place separately from the parents. Also, if a minor will reach adulthood (18 in Missouri)
during the course of the study, they will need to be asked to consent as an adult at that time to continue in
the study.
 
---------------------------------------------------------------------------------------------
* * * HIPAA * * *
15. HIPAA
 
    
 
Studies that access, receive or collect protected health information (PHI) are subject to HIPAA regulations.
PHI is health information with one or more personal identifiers.   For more information refer to the SLU IRB
HIPAA Guidance.
 
    1. Will health information be accessed, received or collected?
No health information. HIPAA does not apply.
X
Yes (continue to question 2).
 
    2. Which personal identifiers will be received or collected/recorded?
No identifiers.  I certify that no identifiers from the list below will be received or collected and
linked to health information. (Skip remainder of page).
Limited identifiers will be received or collected/recorded (study will likely require a data use
agreement). Select Data Use Agreement- INTERNAL or Data Use Agreement- EXTERNAL as
appropriate, below.
City/State/Zip codes
Person-specific dates (e.g., date of birth, dates of service, admission/discharge dates,
etc.)
Age (if subjects are 90+ years)
X
At least one direct identifier will be received or collected/recorded.
X
Names
Social Security numbers
Telephone numbers
Linkable code or any other unique identifying number (note this does not mean the unique
code assigned by the Investigator(s) to code the research data)
All geographic subdivisions smaller than a State, including street address, city, county,
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip
code, if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all zip codes with the same three initial digits
contains more than 20,000 people; and (2) The initial three digits of a zip code for all such
geographic units containing 20,000 or fewer people is changed to 000
X
All elements of dates (except year) for dates directly related to an individual, including
birth date, admission date, discharge date, date of death; and all ages over 89 and all
elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older


Page 32 of 37
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32
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
Fax numbers
Electronic mail addresses
X
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locations (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
 
    
  
If you are receiving or collecting/recording health information and at least one personal identifier, please
continue to complete the sections, below.
 
    3. Sources of Protected Health Information:
X
Hospital/medical records for in or out patients
Physician/clinic records
X
Laboratory, pathology and/or radiology results
X
Biological samples
Interviews or questionnaires/health histories
Mental health records
Data previously collected for research purposes
Billing records
Other
       
     
      
     
Please describe:
 
    4. If data will be shared outside the research team and the study involves PHI indicate how the research
team will share the information.
 
X
Not applicable (continue to question 5).
Only linkable code that can link data to the identity of the subject. A code access agreement or
business associate agreement may be needed when data are shared with other non-SLU
entities. If necessary, the agreement can be added and uploaded in item #5, below.
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited
Data Set. A data use agreement may be needed when data are shared with other non-SLU
entities.  If necessary, the agreement can be added and uploaded in item #5, below, using DUA-
external option.
With unlimited identifiers. The consent document and HIPAA Authorization form must describe
how the information will be disclosed.
 


Page 33 of 37
SLU eIRB
33
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
    5. HIPAA Documentation is required for this study.  Use the table below to add HIPAA Documents for
your study.
 
 
HIPAA Documents
HIPAA Documents
Title
Attached Date
HIPAA Authorization
Approved_HIPAA Authorization
Version 2
01/27/2023
---------------------------------------------------------------------------------------------
* * * Attachments * * *
16. Attachments
In this section, please upload additional documents associated with your protocol. Failure to attach files
associated with the protocol may result in the protocol being returned to you.
 
  Possible documents for this protocol could include:
 •
Bibliography
 •
Cooperating Institution's IRB Approval
 •
Data Collection Sheet
 •
Debriefing Script
 •
Device Information/Documentation
 •
Grant Proposal/Sub-Contract
 •
Human Subjects Training Certificate/Proof of Training
 •
Information Sheet/Brochure
 •
Interview/Focus Group Questions
 •
Investigator's Brochure
 •
Letter of Agreement/Cooperation
 •
IND Application Letter
 •
Package Insert
 •
Patient Diary Form
 •
Questionnaire/Survey
 •
Recruitment Material (e.g., flyers, ads, e-mail text)
 •
Safety Information (DSM Information)
 •
Scientific/PPC Review or Department Chair Review
 •
Sponsor's Protocol
 •
Sponsor's Protocol Amendment
 •
Study Design Chart/Table
 •
Other files associated with the protocol (most standard formats accepted: pdf, jpg, tiff, mp3, wmv,


Page 34 of 37
SLU eIRB
34
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
etc.)
       
To update or revise any attachments, please delete the existing attachment and upload the revised
document to replace it.
 
Document Type
Document Name
Attached Date
Submitted Date
Bibliography
Bibliography
10/18/2021
01/06/2022
Device
Information/Documentatio
n
AccessGUDID - DEVICE_
SurgX™
(00370858000041)
02/01/2022
02/04/2022
Package Insert
APLS31015S_Medline_In
dustries_Inc_05-10-22
05/11/2022
05/11/2022
Device
Information/Documentatio
n
NMS-40015-Rev.-B-
SurgX-IFU
09/30/2022
10/28/2022
Device
Information/Documentatio
n
K163188
09/30/2022
10/28/2022
Package Insert
NMS-40015-Rev.-B-
SurgX-IFU (1)
09/30/2022
10/28/2022
Package Insert
betadine insert
09/30/2022
10/28/2022
Data Collection Sheet
Approved_data collection
sheet 2.0
01/27/2023
01/27/2023
Safety Information (DSM
Information)
Safety Information (DSM
Information)_2024
04/10/2024
04/16/2024
---------------------------------------------------------------------------------------------
* * * PI Obligations * * *
 
PI Obligations
 
By clicking the box  below you indicate that you accept responsibility for and will follow the ethical guidelines set
forth by the Belmont Report, Declaration of Helsinki, the Nuremberg Code, and the Ethical Principles of the
American Psychological Association (if applicable) for the research described. It also indicates that you have the
requisite funding, credentials, training, and any necessary hospital privileges, if needed, to carry out all
procedures and treatments involved in the protocol.
 
Clicking the box  also affirms that the activities involving human subjects will not begin without prior review and
approval by the Institutional Review Board, and that all activities will be performed in accordance with state and
federal regulations and Saint Louis University's assurance with the Department of Health and Human Services.
The PI assures that if members of the SLU research team access protected health information (PHI) from a
covered entity in order to seek consent/authorization for research or to conduct research, such access is
necessary for the research, is solely for that purpose, and the information will not be removed from the covered
entity without IRB authorization or approved waiver. PI further assures that the SLU research team will comply
with the terms of a Data Use Agreement to PHI (if any).


Page 35 of 37
SLU eIRB
35
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
 
1)
Have you completed the annual Conflict of Interest in Research Disclosure Form?
Y
You can only select N/A if you are not currently listed on any externally
funded research projects nor listed on any proposals
for externally funded research support.
 
NOTE: An annual disclosure must be completed by all faculty, staff and students involved in the design,
conduct or reporting of externally funded research applications and awards.
 
2)
Have your financial interests changed significantly since you completed the annual
disclosure form?
N
 
The PRINCIPAL INVESTIGATOR certifies that he/she has read the University's Conflict of Interest Research
Policy and has checked the appropriate box in the 'Potential Conflict of Interest' section of the application. In
addition, the PRINCIPAL INVESTIGATOR certifies that, to the best of his/her knowledge, no person working on
this project at SLU has a conflict of interest or if a conflict of interest does exist, that an appropriate management
plan is in place.
 
According to the Saint Louis University Conflict of Interest in Research Policy, as PI, it is your responsibility to
inform co-investigators, staff, or students involved in the design, conduct, or reporting of externally sponsored
research of their requirement to complete a Conflict of Interest in Research Disclosure Form.
 
X
I accept this responsibility.
 
 
X
The Principal Investigator has read and agrees to the above certifications and will abide
by the above obligations.
---------------------------------------------------------------------------------------------
* * * Event History * * *
Event History
Date
Status
View Attachments
Letters
09/12/2024
CONTINUING REVIEW 2
FORM APPROVED
Y
Y
05/17/2024
PROTOCOL EXPIRED
04/29/2024
CONTINUING REVIEW 2
FORM REVIEWER(S)
ASSIGNED


Page 36 of 37
SLU eIRB
36
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
04/22/2024
CONTINUING REVIEW 2
FORM PANEL
MANAGER REVIEW
04/22/2024
CONTINUING REVIEW 2
FORM PANEL
REASSIGNED
04/16/2024
CONTINUING REVIEW 2
FORM SUBMITTED
Y
03/19/2024
CONTINUING REVIEW 2
FORM CREATED
05/22/2023
CONTINUING REVIEW 1
FORM APPROVED
Y
Y
05/17/2023
PROTOCOL EXPIRED
04/10/2023
CONTINUING REVIEW 1
FORM REVIEWER(S)
ASSIGNED
04/10/2023
CONTINUING REVIEW 1
FORM PANEL
MANAGER REVIEW
03/28/2023
CONTINUING REVIEW 1
FORM SUBMITTED
Y
03/19/2023
CONTINUING REVIEW 1
FORM CREATED
01/27/2023
NEW FORM APPROVED
Y
Y
01/25/2023
NEW FORM
REVIEWER(S)
ASSIGNED
10/28/2022
NEW FORM
SUBMITTED (CYCLE 1)
Y
05/23/2022
NEW FORM
CONTINGENT
05/10/2022
NEW FORM
REVIEWER(S)
ASSIGNED
05/09/2022
NEW FORM
REVIEWER(S)
ASSIGNED
05/09/2022
NEW FORM PANEL
MANAGER REVIEW
05/09/2022
NEW FORM PANEL
REASSIGNED
05/03/2022
NEW FORM PANEL
REASSIGNED
02/07/2022
NEW FORM PANEL
REASSIGNED
02/04/2022
NEW FORM
RESUBMITTED
Y
01/28/2022
NEW FORM RETURNED


Page 37 of 37
SLU eIRB
37
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 32325
Otto
Protocol Title:
SURGX antimicrobial gel versus povidone-iodine skin incision prep for the prevention of
bacterial seeding in total shoulder arthroplasty
----------------------------------------------------------------------------------------------------
01/07/2022
NEW FORM PANEL
ASSIGNED
01/06/2022
NEW FORM
SUBMITTED
Y
01/06/2022
NEW FORM
PREREVIEWED
12/19/2021
NEW FORM
PREAPPROVAL
10/18/2021
NEW FORM CREATED