Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
Phase: NA
Conditions: Rhino Sinusitis
Sponsor: St. Louis University

 
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
 Date Printed: 04/07/2018
Personnel Information
1
Subject Population
6
Study Location
6
General Checklist
7
Funding
8
Expedited Paragraphs
8
Background, Purpose, Study Procedures
10
Radioisotopes or Radiation Machines
15
Devices
16
Drugs, Reagents, Chemicals, or Biologic Products
20
Other Levels Of Review
20
Subject Population
22
Subject Population
23
Risks
24
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
28
Potential Conflict of Interest
34
Informed Consent
35
Assent
37
HIPAA
37

Page 1 of 40
SLU eIRB
1
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
------------------------------------------------------------------------------
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
Protocol Status:
APPROVED
Date Submitted:
01/31/2018
Approval Period:
03/04/2018-03/31/2019
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
Antisdel, Jastin
MD
Assistant Professor
Email
Phone
Fax
antisdel@slu.edu
(314) 577-8885
Department Name
 
 
Otolaryngology
 
 
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?*
Dr. Antisdel has many years of clinical trial experience
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine Subject Eligibility for Accrual
4a.
X Subject Physical Examinations
4b.
X 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
9.
X Report Data (CRFs, e-CRFs, Spreadsheets)
10.
X Data Analysis
11a.
X Review Adverse Events
11b.
X Treat and Classify Adverse Events

Page 2 of 40
SLU eIRB
2
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
antisdel
03-08-2017
Good Clinical Practice (GCP)
antisdel
02-19-2007
CITI Biomedical Research Basic
Training
 
Administrative Contact
Name of Administrative Contact
Degree
Title
Webb, Deniece
BA
Administrative Assistant I
Gallogly, James
BS
Student
Administrative Contact
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.
Name of Administrative Contact
Degree
Title
Webb, Deniece
BA
Administrative Assistant I
Email
Phone
Fax
deniecewebb@slu.edu
(314) 577-8885
Department Name
 
Otolaryngology
 
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
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.)
 
 

Page 3 of 40
SLU eIRB
3
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
UserID
CourseCompletionDate
Course
deniecewebb
02-23-2016
Good Clinical Practice (GCP)
deniecewebb
01-13-2016
CITI Biomedical Research Basic
Training
Name an Administrative Contact if someone in addition to the PI should be contacted about the protocol.
Name of Administrative Contact
Degree
Title
Gallogly, James
BS
Student
Email
Phone
Fax
jgallogl@slu.edu
314-577-8884
Department Name
 
Otolaryngology
 
Is this individual also a member of the research team?
Y
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?
1.  Case report with Dr. Brunworth, Dept. of Otolaryngology (2016)--Mechanical Restriction of the Medial
Rectus Due to Unknown Inflammatory Disease: A Case Report
2.  Basic science research at Stowers Institute for Medical Research, undergraduate researcher, poster
(2014)--Lysine-to-Methionine Mutation Alters Histone Protein Interaction
3.  Basic science research at Stowers Institute for Medical Research, undergraduate researcher (2013)
4.  SLU Emergency Medicine Research Associates Program, research associate and associate chief
(2012-2014)--identified and enrolled eligible patients, collected data, oversaw 40 undergraduate
researchers
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.
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.
X Subject Randomization or Registry
8.
X Collection of Subject Data
9.
X Report Data (CRFs, e-CRFs, Spreadsheets) 10.
X Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
UserID
CourseCompletionDate
Course
jgallogl
04-24-2012
CITI Biomedical Research Basic
Training
 

Page 4 of 40
SLU eIRB
4
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
Key Personnel (Research Team)
Name of Key Personnel
(Research Team)
Degree
Title
Department Name
Brunworth, Joseph
MD
Assistant Professor
Otolaryngology
 
 
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
Mikulec, Anthony
MD
Professor
Email
Phone
Fax
mikuleca@slu.edu
(314) 577-8885
Department Name
 
 
Otolaryngology
 
 
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
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
mikuleca
07-15-2005
CITI Biomedical Research Basic
Training
mikuleca
03-01-2016
Good Clinical Practice (GCP)
 

Page 5 of 40
SLU eIRB
5
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
Research Team Roles
Name(s), Degree
Department
Experience
Duties
 Antisdel, Jastin, MD
Otolaryngology
Dr. Antisdel has many years
of clinical trial experience
 Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations, Follow-up
Visits including physical
assessments, 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
 Gallogly, James, BS
Otolaryngology
1.  Case report with Dr.
Brunworth, Dept. of
Otolaryngology (2016)--
"Mechanical Restriction of
the Medial Rectus Due to
Unknown Inflammatory
Disease: A Case Report"
2.  Basic science research
at Stowers Institute for
Medical Research,
undergraduate researcher,
poster (2014)--"Lysine-to-
Methionine Mutation Alters
Histone Protein Interaction"
3.  Basic science research
at Stowers Institute for
Medical Research,
undergraduate researcher
(2013)
4.  SLU Emergency
Medicine Research
Associates Program,
research associate and
associate chief (2012-2014)-
-identified and enrolled
eligible patients, collected
data, oversaw 40
undergraduate researchers
Recruitment, Obtains
consent, Determine
Subject Eligibility for
Accrual, Subject
Randomization or
Registry, Collection of
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets), Data
Analysis
 Brunworth, Joseph, MD
Otolaryngology
As a fellowship trained
Recruitment, Obtains

Page 6 of 40
SLU eIRB
6
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
Otorhinolaryngologist, Dr.
Brunworth has been
involved in clinical and basic
science research for the last
11 years. He serves in the
capacity of scientific
reviewer for a number of
OTO's IRBs.
consent, Determine
Subject Eligibility for
Accrual, Subject Physical
Examinations , Follow-up
Visits including physical
assessments, 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
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
 
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

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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
      
Indicate where the study will be conducted. Select all that apply:
X
Saint Louis University, Medical Center Campus
Saint Louis University, Frost Campus
Saint Louis University, Madrid Campus
X
Saint Louis University, SLUCare Practice Locations
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
X
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 :
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
FDA approved  drugs, reagents, other chemicals administered to subjects (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
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
X
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

Page 8 of 40
SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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
 
X
NONE
 
Funding - Grants/Contracts
 
 
Funding - Industry Sponsor
 
 
 
  
  
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.)
 

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SLU eIRB
9
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
        
    
 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.
    
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.
 

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SLU eIRB
10
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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.)
 
X
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.
 
X 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
Analysis of hemostatic agents compared to physiologic hemostasis
 
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
 

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SLU eIRB
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
     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?*
In this study we wish to determine if the use of hemostatic agents after endoscopic sinus
surgery is superior to no agent at all.  We will treat patients with one of many different FDA
approved hemostatic agents in one of their nostrils and compare it to a side in which no therapy
is applied.  We will then evaluate qualities of the patient’s recovery (synechiae formation,
granulation, edema, infection, and time spent debriding the sinuses) in response to intervention.
Functional endoscopic sinus surgery (ESS) is a safe, commonly performed procedure primarily
in an outpatient setting.  One of the most prevalent complications is post-operative epistaxis.
To prevent this nasal packing is often employed.  Traditionally non-absorbable packing was
employed; yet, this has fallen out of favor with most otolaryngologists considering the great
discomfort of the packing, especially upon removal (von Schoenberg).  In addition to this, with
removal of non-absorbable packing interruption of the wound bed is inevitable.  This has led to
a paradigm shift towards absorbable packing, which are biomaterials that provide substrate to
stimulate clotting.  Absorbable hemostatic agents tend to spare the mucosa and are less painful
upon removal (Maccabee).  However, absorbable packing comes with the possible drawback of
increased rates of synechiae formation secondary to initiation of local inflammation (Valentine).
Standard of care is no packing, one of these types of absorbable packing, or removing packing.
a). Sinufoam is a carboxymethylcellulose (CMC) derivative which provides a moist wound
environment and with its viscosity and density, provides a scaffold for epithelialization and
pressure lateralization against surfaces to which it is applied (Al-Reefy).  On the other hand,
Arista is composed of potato-starch derived mucopolysaccharide hemospheres (MPH) which
are rapidly cleared from the human body with minimal interruption in wound healing (Antisdel).
Nexfoam is made from plant pectin and is also rapidly cleared from the nasal cavity.
b).  AristaTM is FDA approved for endonasal use and is currently available on the market.
NexfoamTM is FDA approved for use as a topical dressing for the temporary treatment of
moderate to severely bleeding wounds such as surgical wounds (post operative, donor sites,
dermatological) and it has the number: K070211 under the name of TraumArrestTM.  It also
falls under Class I medical device that is exempt from the premarket notification procedures.
SinufoamTM (Stamberger) is included under Rapid Rhino product line (RR 650) and it is a
Class I medical device, FDA product registration is attached.
c). Nasopore nasal dressing is a fragment-able nasal dressing and is indicated for use in
patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent
adhesions between mucosal surfaces; to help control minimal bleeding following surgery or
nasal trauma by tamponade effect and blood absorption.  It is FDA approved and filed under
number K052099.
d). Nexfoam is a sterile, topical wound dressing comprised of plant based polysaccharides.
The hemostatic particles dehydrate blood cells, resulting in hemoconcentration of platelets,
serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.  It is FDA
approved and filed under number K122886.
e). The Hemostasis PosiSep and PosiSep X Hemostat Dressings are sterile hemostats
comprised
of modified Chitosan particles and polysaccharide binders. Chitosan has well known
hemostasis
properties and, when combined with carboxymnethylcellulose and hydroxyethylcellulose
binders,
forms a foam-type dressing that has an affinity to absorb and hold water. The PosiSep and
PosiSep X Hemostat Dressings are used for topical wounds. The dressings quickly dehydrate
blood cells, thereby
causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting
that limits and controls bleeding and edema. It is FDA approved and filed under K120958.
f). Sinufoam, Arista, Nasopore, Nexfoam, Posisep and PosiSep X are all being used for
purposes approved following sinus surgery by the FDA.

Page 12 of 40
SLU eIRB
12
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
purposes approved following sinus surgery by the FDA.
 
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.
Our study is a prospective comparison between absorbable hemostatic agents as a group and
the body’s natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus
surgery with or without septoplasty.
 
     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).
The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in
comparison with physiologic hemostasis after endoscopic sinus surgery.  We aim to determine
the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of
epistaxis observed without therapy.  Also will evaluate objective healing parameters.
 
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.
Our study is a prospective comparison between absorbable hemostatic agents as a group and
the body’s natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus
surgery with or without septoplasty.
We calculated the sample size and power analysis in the following way:
Given the number of statistical tests, we calculated a Bonferonni correction to set the alpha for
the analysis at 0.017 (alpha originally at .05 divided by the number of tests  = .05/30 = 0.017).
Using G-Power statistical software, power analyses were completed using the Means:
Wilcoxen-Mann-Whitney test (two groups). Given alpha at 0.017 and Power at 0.80, we
determined that a total of 244 participants (122 in the control group, 122 in the hemostatics
group) would be needed to detect a medium effect size (d=0.5).  Since one nostril will be used
as the control and the therapy applied to the other side, the number of participants needed
drops to 122.
Based on previous studies, we conservatively expect a dropout rate of 15%. In order to
maintain the same number of participants, we would need to enroll a total of 144 participants
Postoperatively, patients will rate subjective symptoms such as nasal obstruction, bleeding,

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Analysis of hemostatic agents compared to physiologic hemostasis
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pain, and nasal discharge on a scale ranging from 1-10, of which 10 is the most severe.
Similarly, the treating physicians on endoscopic examinations will rate objective measures such
as mucosal edema, infection, time spent debriding, and synechiae formation.  (Please see the
attached patient and physician questionnaires) Patient questionnaires will be completed on
postoperative days #1, 2, 7, and 14.  Surgical healing outcomes will be noted during routine
postoperative visits 1 and 2 weeks after surgery.  Expected total duration of each subjects’
participation is 6 weeks.  Total subject accrual should take no longer than one year.  Data
analysis will take up to three months.  Estimated time of completion is 03/2018.
 
  
  
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
tables, charts, etc., attach those files in the Attachment section (#16).
a.)  Patients will have (standard of care) Endoscopic Sinus Surgery.
b.) Each patient will receive a hemostatic agent in one nostril and nothing in the other nostril.
c.) Products will be placed in patients’ post-operative sinus cavities at the end of the procedure
according to company recommended instructions.  Essentially all products placed in the middle
meatus are allowed to remain there until absorbed or removed at a post operative visit on
weeks 1, 2, and 6.  Post-operative irrigations (Standard of Care) will remove much of the
material.  Any residual material is removed in the office on normal, (Standard of Care) post-
operative debridement on weeks 1, 2, and/or 6.
d.)  Subjects will provide subjective pre- and post-operative data, such as rating their pain,
bleeding, obstruction, and discharge on days 0, 1, 2, 7, and 14 (Standard of Care).
e.)  Patients will be given a questionnaire packet pre-operatively (Research Related).
Questionnaires will include post-operative data on days 0, 1, 2, 7, and 14.  They are asked to
bring completed questionnaires on standard post-operative visits.
f.)  The physician will record objective and subjective data (synechiae, edema, infection,
granulations, and time spent debriding) upon regular reexamination of the sinuses after
surgery, at post-operative visits on weeks 1, 3, and 6.  All procedures are standard clinical care.
g.)  Follow up visits will conform to standard clinical care; patients will be seen in the physician’s
clinic.

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Analysis of hemostatic agents compared to physiologic hemostasis
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clinic.
 
  
  
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.
If side effects or discomforts do occur, Dr. Antisdel and/or Dr. Brunworth will try to minimize and
treat these by irrigating the treated sinus with saline to remove the Arista, Nexfoam, Sinufoam,
Nasopore, Posisep, or Posisep X.
 
  
  
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.
Means and standard deviations will be obtained for data collected from patients and the
physician.  These outcomes will be used for comparative evaluation of hemostatic agents
(n=144) against no therapy.  Statistics will include descriptive statistics and a non-parametric
ANOVA comparing the questionnaire patient data and the physician data followed by Post-hoc
multiple comparisons.
 
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 for the use of hemostatic agents - half of surgeons use an
absorbable hemostatic agent and half use no hemostatic agent.
 
   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
N

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looking for it).
 
    
  
   
If yes, please describe and include whether there are plans to share findings with study
participants.
 
    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 first, even before submission to IRB. 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.
 

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Analysis of hemostatic agents compared to physiologic hemostasis
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NOTE: Informed Consent Radiation Exposure Risk Statement- The applicant must insert the appropriate
Informed Consent Radiation Exposure Risk Statement template language 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. 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).
Arista
Medafor
exempt
Nexafoam
Hemostasis
exempt
Sinufoam
Arthrocore
exempt
Nasopore
Polyganics
exempt
Posisep Hemostat Dressing
Hemostasis
exempt
Posisep X Hemostat Dressing
Hemostasis
exempt
1.
Device Name
Arista
2.
Manufacturer
Medafor
3.
Describe the device to be used and attach the device manual in section #16.
hemostatic agent
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)

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Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Medafor
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
Nexafoam
2.
Manufacturer
Hemostasis
3.
Describe the device to be used and attach the device manual in section #16.
hemostatic agent
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Hemostasis
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
Sinufoam
2.
Manufacturer
Arthrocore
3.
Describe the device to be used and attach the device manual in section #16.
hemostatic agent
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.

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Protocol # 24331
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Analysis of hemostatic agents compared to physiologic hemostasis
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5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Arthrocore
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
Nasopore
2.
Manufacturer
Polyganics
3.
Describe the device to be used and attach the device manual in section #16.
hemostasis
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Polyganics
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
Posisep Hemostat Dressing
2.
Manufacturer
Hemostasis

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Protocol # 24331
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Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
3.
Describe the device to be used and attach the device manual in section #16.
Hemostatic agent
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Hemostasis
9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
1.
Device Name
Posisep X Hemostat Dressing
2.
Manufacturer
Hemostasis
3.
Describe the device to be used and attach the device manual in section #16.
Hemostatic agent
4.
Provide the PMA approval or 510(k) clearance
number or attach letters in section #16.
5.
Does the research involve use of a commercially
available device for an unapproved purpose?
6.
This device research is:Note: Attach
documentation/justification in section #16.
Exempt from IDE regulations, (submit
required attachments)
Non-Significant risk, (submit required
attachments)
Significant risk, (submit required
attachments)
The risk determination should be based on the proposed use of a device in an investigation and not on the
device alone.
7.
Provide IDE #. Documentation of IDE # required
unless imprinted on sponsor protocol (attach in
section #16).  See Guidance.
exempt
8.
Who holds the IDE? (Could be manufacturer, study
sponsor, or an individual investigator acting as the
'sponsor').
Hemostasis

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Protocol # 24331
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Analysis of hemostatic agents compared to physiologic hemostasis
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9.
If a SLU Investigator is serving as sponsor-
investigator of the IDE, click Yes to assure that the
additional FDA requirements will be followed.
Yes, the additional FDA requirements will be
followed.
---------------------------------------------------------------------------------------------
* * * 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).
 
 
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).
 
 
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
 
 
Please read the  IND Statements.
 
---------------------------------------------------------------------------------------------
* * * 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  instructions or
contact the Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials (per instructions, submit to RSC before IRB)

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Protocol # 24331
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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.
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@ssmsluh.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 ABI and the infusion center at DOB) and medical
record access, requires approval from the Saint Louis University Hospital Research Review Committee
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. Documents should be
submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact the
Research Compliance Office at 577-8113 or sluh-research@ssmhealth.com of the SLU Clinical Trials
Office (CTO) at 977-6335 or clinical-trials-office@health.slu.edu for more information.
Not Applicable
X
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

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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.
X
Not Applicable
Yes, study requires RBR review
 
 
6.
&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 yrs to 75 years
 
b)  
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all
sites under the direction of the SLU PI).
144
 
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?*
144
 
d)
If including vulnerable populations (<a
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>minors, <a
href=https://www.slu.edu/Documents/research/IRB/Pregnant_Women_Fetuses.docx
target=_blank>pregnant women and fetuses, <a
href=https://www.slu.edu/Documents/research/IRB/Neonates.docx target=_blank>neonates, <a
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc
target=_blank>non-English speaking, economically or educationally disadvantaged, <a
href=https://www.slu.edu/Documents/research/IRB/Prisoner_Research.doc target=_blank>prisoners, <a

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href=https://www.slu.edu/Documents/research/IRB/Prisoner_Research.doc target=_blank>prisoners, <a
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx
target=_blank>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 <a
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general-
guidelines target=_blank>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?*
Children are not included because the study is being done from an adult clinic.
 
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 <a
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general-
guidelines target=_blank>SLU Guidelines for additional considerations and strategies for mitigating risks.
 
g)
Describe how potential subjects will be identified for recruitment (e.g., chart review, referral from individual's
treating physician, those individuals answering an ad). How will potential participants learn about the
research, and how will they be recruited (e.g., flyer, e-mail, web posting, telephone, etc.)? Upload
recruitment materials in the Attachment Section (#16). Important to remember: potential subjects cannot be
contacted before IRB approval. NOTE: The use of SLU owned websites in an approved SLU format (e.g.,
Cancer Center website, etc.) are always approved methods of recruitment.
a.) The patients selected for this study will be recruited and treated by physicians, Dr. Jastin Antisdel and
Dr. Joe Brunworth, at the Saint Louis University Hospital and Saint Louis University UMG Practice
Locations (St. Louis, MO).
b.) Potential subjects will be recruited in person by the physician during regular appointments.
c.) Study information may be posted to a SLU approved website in a standard approved format.
---------------------------------------------------------------------------------------------
* * * 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.
Inclusion criteria:  ≥18 to <75 years of age with bilateral chronic or recurrent rhino sinusitis recalcitrant
to medical therapy that requires ESS.  Sinuses should have a similar degree of disease involvement
bilaterally.
 
 
  
Identify exclusion criteria.

Page 24 of 40
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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
Exclusion criteria:
(1) massive sinonasal polyposis,
(2) history of underlying immunologic diseases, AIDS, cystic fibrosis, immunoglobulin deficiency,
immotile cilia syndrome, and neutropenia,
(3) known hypersensitivity to the aforementioned agents,
(4) women who are pregnant or breastfeeding,
(5) anyone with a known allergy to any of the treatments (potato starch, iodine, shellfish)
(6) anyone with a known coagulopathy
 
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.
No monetary compensation was offered to either the participants in this study or the investigators,
physicians or other health care providers for identifying and enrolling subjects.
 
j)
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
All procedures are standard of care; no additional research-related costs will be incurred.  Insurance will be
billed for the standard of care procedure.  The study hemostatic agents are part of the total cost for the
operation.  There is no difference in the cost of a procedure that uses hemostatic agents and one that does
not use hemostatic agents.
 
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.
Each patient's participation is expected to be about six weeks.  Study should be complete by 3/31/2018.
Patients will be recruited and added to the study as they are seen in clinic.  Each subject's participation is
expected to be six weeks total. Evaluation at six weeks post operation is standard of care for Endoscopic
Sinus Surgery. Subject accrual should take no longer than one year to achieve the goal of 144 patients.
Data analysis will take up to 3 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.
 

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
 
 
 
    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.
 
 
 
 
 
    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.
a.)  The risks of this study are minimal and non-life threatening.
There are certain risks and discomforts that may be associated with this research.  They include:
1) Allergic-type Adverse Reaction
There is a rare possibility of an allergic-type adverse reaction to AristaTM, NexfoamTM, SinufoamTM
NasoporeTM, NexfoamTM and PosisepTM and PosisepX TM.  Patients may experience itching, hives,
hay fever symptoms, wheezing, difficulty breathing, and/or new swelling.  These reactions may be
serious or life threatening.  These are the same risks they would have if they did not participate in the
study.
2) Bleeding.
3) Obstruction/Blockage of sinus passage.  Post operative irrigations will remove any excess material.
Also, debridement during post operative visits will remove any material that irrigation can't.
4) Pain
5) Infection-- Dr. Antisdel and Dr. Brunworth will evaluate patients for signs of infection during post
operative visits.
6) Delayed/ Asymmetric healing. One nostril will receive therapy while the other will not receive
therapy.  If therapy decreases wound healing time, asymmetric healing/healing may occur.
7) Embolization and Death.  This risk has been identified with Arista AH.  However, this risk exists only
if Arista AH is directly injected into blood vessels.  In this study we will only apply Arista topically to the
interior of a patient's nostril.  Nothing will be injected into or applied to an open vessel. Furthermore,
any excess Arista will be removed with postoperative irrigation.
There are no other additional adverse reactions to these products associated with being in this study.
 
 
 
 
 
    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).
Unknown Side Effects
There is always the risk of developing previously unknown side effects.
Patients may encounter these risks regardless of participation in this research study.
If side effects or discomforts do occur, Dr. Antisdel will try to minimize and treat these by irrigating the

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
treated sinus with saline to remove the Arista, Nexfoam, Sinufoam, Nasopore, Nexfoam, Posisep and
Posisep X.
The investigator is wiling to discuss any questions the participant might have about these risks and
discomforts.
 
 
 
 
 
    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?*
There is conflicting data in previous studies whether hemostatic agents are better than treatment with
nothing or all.  The goal is to answer that question definitively.  Other options are to have both sides
treated with a hemostatic, have neither side treated, or to place non-absorbable packing material that
requires later removal.
 
 
 
 
 
    8.
Describe any psychological, social, or legal risks the subject may experience.   *?HELP?*
Breach of Confidentiality
Information will be kept under lock and key with password protection on the computer.  Coding will be
used with no patient identifiers attached to confidential information.  Even with these precautions,
breach of confidentiality is a risk.
Use of Questionnaires:
Some questions in the questionnaires may make subjects feel uncomfortable. Subjects may choose
not to answer any question with which he/she feels uncomfortable.
 
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.
If side effects or discomforts do occur, Dr. Antisdel and Dr. Brunworth will try to minimize and treat
these by irrigating the treated sinus with saline to remove the Arista, Nexfoam, Sinufoam, and
Nasopore. Also, removal of excess hemostatic agents during irrigation will lessen the risk of
obstruction, embolization and death.  The risk of embolization and death are only present if a
hemostatic agent is directly injected or placed onto an open vessel.  This will not be happening in this
study. Hemostatic agents will only be topically applied to sinuses post operatively.
Use of questionnaires:
Subjects may choose not to answer any question with which he/she feels uncomfortable

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
 
 
 
  
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).
Some research medications or procedures can cause severe birth defects, mental retardation to an
unborn baby, or loss of the unborn baby.  If patients take part in a research study that includes a drug
or medical procedure, they must be willing to have a pregnancy test done before beginning their
participation.  Patients must avoid becoming pregnant while they take part in the research study.
 
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/A
 
 
 
 
 
          
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.
 
     
b.
  Is there a Data Safety Monitoring Plan (DSMP)?
N
 
 
 
 
 
          
Note, if all relevant plan information is included in DSMB question above, select 'Yes' and state "see
above" in the answer box.

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
 
 
 
 
          
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).
 
 
 
 
 
          
If no, please justify why not.
All procedures are standard of care.  Risks are minimal.
 
   
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.
 
 
 
 
    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.
 
          NOTE: Export control laws include the transfer of technical information and data, as well as information
and technology to foreign nationals. If this study has international components, contact the  SLU Export
Control 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.
a.)  Subjects will not benefit from the research.
b.)  Society may benefit from research findings because they will provide physicians with evidence of the
effects and side effects of available hemostatic agents, and help them make well educated decisions about
which agents are best in practice.
 
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
applicable.
The alternative to absorbable packing is the use of non-absorbable packing (this is used as standard of
care if the patient is experiencing excessive bleeding and requires a tamponade).  Patients may also
receive the absorbable packing off study with the same product in both nostrils.  Other alternatives include
to not use any packing or to not participate in the study.
 
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
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:
&nbsp&nbsp&nbsp&nbsp&nbspAnonymous/De-identified: data contain no identifiers, including code
numbers that investigators can link to &nbsp&nbsp&nbsp&nbsp&nbspindividual identities;
&nbsp&nbsp&nbsp&nbsp&nbspCoded: data in which (1) identifying information, such as name or social
security number, has been replaced &nbsp&nbsp&nbsp&nbsp&nbspwith a number, letter, symbol, or
combination thereof (i.e., the code), and (2) a key to decipher the code exists
&nbsp&nbsp&nbsp&nbsp&nbspenabling linkage of data to identifying information (e.g., a master list), and
(3) the key (master list) is kept &nbsp&nbsp&nbsp&nbsp&nbspseparately from coded data; AND/OR
&nbsp&nbsp&nbsp&nbsp&nbspIdentifiable: data that includes personal identifiers (e.g., name, social
security number), such that &nbsp&nbsp&nbsp&nbsp&nbspinformation 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)

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
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 network storage
(T: drive (shared drive),
U: drive (personal drive))
Not Applicable, I will not
be sending/sharing
electronic data outside of
SLU
1. What type of electronic (computer) data does your study involve? Note: only one data type can be
selected. Click on Add from the main page to enter information for additional data types once you've
saved this information.
 
Anonymous/De-identified
 
X
 Coded
 
Identifiable
2.
Where are the data being kept/collected? (Check all that apply)
NOTE: THE ITEMS LISTED BELOW IN ITALICS CANNOT BE USED FOR DATA WHICH ARE (1)
SENSITIVE AND CODED OR (2) IDENTIFIABLE unless an exception has been granted by the SLU
Info Security Team (InfoSecurityTeam@slu.edu). Please attach proof of exception in section #16.
 
SLU ITS managed device (computer, tablet, etc.) with encryption
 
SLU ITS managed device (computer, tablet, etc.) without encryption
 
X
SLU ITS network storage (T: drive (shared drive), U: drive (personal drive))
 
SLU ITS recognized document-level encryption
 
SLU Google Drive/Documents (can only be shared with slu.edu addresses)
 
Collection or Storage of data in SLU REDCap
 
Collection or Storage of data in SLU Qualtrics
 
Removable storage devices (flash drive, USB hard drive) with encryption
 
Removable storage devices (flash drive, USB hard drive) without encryption
 
Personally owned/non-SLU managed device (computers, tablets) with encryption
 
Personally owned/non-SLU managed device (computers, tablets) without encryption
 
Third party services such as Dropbox, Box, Evernote, SurveyMonkey,
etc. (Please specify):
 
Sponsor provided system or portal (Please specify):
 
Other (Please specify):
3. If the data will be sent/shared outside of SLU, how are they being sent/shared? (Check all that apply)
 
X
Not Applicable, I will not be sending/sharing electronic data outside of SLU
 
SLU Email account with an encrypted file attachment
 
Posting of data directly to an external web portal using secure connection (i.e., HTTPS)

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
Sending of data to a secure FTP site (e.g., SFTP, FTPS)
 
Use of Virtual Private Network connection (VPN)
 
Use of SLU REDCap account
 
Use of an external Secure Web Mail account
 
Physical delivery of encrypted files via CD/DVD or other medium (e.g., USPS, FedEx, Courier)
 
Other (Please specify):
4. Supplemental information related to above items can be entered here or leave blank:
 
b)
Hardcopy (Paper) Data
 
     
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 Suite
Personnel Supervision
1. What type of hardcopy (paper) data does your study involve? Note: only one data type can be selected.
Click on Add from the main page to enter information for additional data types once you've saved this
information.
 
Anonymous/De-identified
 
 Coded
 
X
Identifiable
2. Where are hardcopy materials being kept? (Check all that apply)
 
X
SLU Locked Cabinet
 
SLU Locked Room/Office
 
X
SLU Locked Suite
 
SLU Long Term Storage Facility
 
Non-SLU Location (Please specify):

Page 32 of 40
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
Other (Please specify):
3. If hardcopy materials are transported at any time in the study (e.g., from data collection site to storage
site, shared with co-investigators), how are they secured?
 
Locked container
 
X
Personnel Supervision
 
Physical delivery (e.g., USPS, FedEx, Courier)
 
Fax Machine
 
SLU Email account with an encrypted file attachment
 
Non- SLU Email account with an encrypted file attachment
 
Other (Please specify):
4. Supplemental information related to above items can be entered here or leave blank:
 
 
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.)  For initial data collection identifier information (name, MRN, etc.) will be necessary.  The master list
containing the identifier information of the subjects will only be available to the PI, co-investigator and
study coordinator.  This list will consist of a Study ID number and the identifiable information will be kept
according to this ID.  The list will be kept in a locked cabinet in the Department of Otolaryngology-- Head
and Neck Surgery.  Any data taken from the medical record will be manually entered onto data collection
sheets identified by study number only.  Medical Records will be obtained from Saint Louis University
Hospital.  This includes the sex, ethnicity, age, surgical pathology, treatment type and duration.  In
addition, pre-treatment and post-treatment radiographic imaging (CT scans and MRIs) is to be acquired
from the Kodak™ Directview Radiology Image Server used at Saint Louis University Hospital respectively.
     Since this is a prospective study, it is important to emphasize that the data and materials were obtained
with the primary intention to diagnose and treat rather than for research purposes only.  Existing records
and data will continue to be used for treatment of future related sequelae of this disease process.
b.) The PI, co-investigator, and study coordinator will be the only people with access to identifiers or coded
information.
c)  No samples or data will be provided from an outside source.
d)  We will not be audio/video taping or photographing subjects.
e)  No data will be collected via email or the internet.
 
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.
N/A
 
 
e)
If samples or data will be provided to SLU from an outside source, indicate whether you will  have access
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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 <a
href=https://www.slu.edu/Documents/research/IRB/Epic_Research_Charting_Policy.pdf
target=_blank>SLUCare Epic Research Charting Policy and <a
href=https://www.slu.edu/Documents/research/IRB/Reasearch_Documentation_Epic.pdf
target=_blank>Clinical Workflow: Documenting Research Encounters in Epic.
not applicable
 
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
 
Priv
acy
 
 
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

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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
 
 
       
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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 <a
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc
target=_blank>SLU Guidelines for Involving Non-English Speaking Subjects for more details).

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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
a.)  Informed consent will be sought from the patient at the time of their out-patient visit.
b.)  An Institutional Review Board approved Investigator will initially discuss the study with the
potential subject, including the risks, benefits, and alternatives.  The study coordinator may be
involved to discuss procedures and arrange testing, should consent be obtained.  The
reconfirmation of consent at subsequent visits will be the responsibility of both the study coordinator
and the PI.  The subject will be provided with information about the study and their role in it.  They
will be informed that they may terminate their participation at any time for any reason.  The informed
consent process will be documented using a standard Research Enrollment Note, which will include
information regarding what version of the Informed Consent document (ICD) was used, who
discussed the study with the subject, that questions/answers occurred, that no study-related activity
was performed until after execution of the ICD, and the time of actual consent.
c.)  The discussion will occur at the time of the surgery consultation as part of the decision to
undergo ESS, since the use of the agents being evaluated is standard of care.  The patients will
have no limit on time to consent.
d.)  The discussion will occur in the physician's clinic in a private, quiet environment.
e.)  If the subject could not write, they would be allowed to make their mark on the appropriate
signature line of the ICD, and the process will be witnessed.  These issues would be documented in
the Research Enrollment Note.
 
  
  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 <a
href=https://www.slu.edu/Documents/research/IRB/LAR_Guidelines.docx target=_blank>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 <a
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx
target=_blank>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_Consent version 4
Consent
03/10/2017
  Title
Approved_Consent version 4
  Consent Type
Consent
Upload Consent Form/Document
X Attachment 
Approved_24331 consent v4

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37
PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
Upload your informed consent document. Use the SLU Informed Consent Template to create your consent
document. If more than one consent will be used (e.g., adult consent, parental consent, etc.), label the
consent documents with these headings to help distinguish them from one another.
 Upload any assent documents which will be used for adults who are unable to provide consent here and
not in the assent section.
Address the following question. A Yes/No response is not adequate.
---------------------------------------------------------------------------------------------
* * * Assent * * *
14. Assent
     
Complete this section if your study includes minors. The Assent Form Template provides
guidelines for writing assent documents.
 
     
 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 <a
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>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.
 
  
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

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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
 
    
 
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 visit the  IRB HIPAA
page or 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)
At least one direct identifier will be received or collected/recorded.
X
Names
Social Security numbers
Telephone numbers
X
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)
X
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
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

Page 39 of 40
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Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
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
X
Physician/clinic records
Laboratory, pathology and/or radiology results
Biological samples
X
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.
 
    5. HIPAA Documentation is required for this study.  Use the table below to add HIPAA Documents for
your study.
 
 
HIPAA Documents

Page 40 of 40
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PROTOCOL
Biomedical Research
Saint Louis University
Protocol # 24331
Antisdel
Protocol Title:
Analysis of hemostatic agents compared to physiologic hemostasis
----------------------------------------------------------------------------------------------------
HIPAA Documents
Title
Attached Date
HIPAA Authorization
hippa authorization form 24331
03/20/2014
HIPAA Authorization
24331 marked HIPAA
04/09/2014
HIPAA Authorization
HIppA authorization form 24331
Version 2
04/16/2014
HIPAA Authorization
Approved_HIppA authorization form
24331 Version 2
05/13/2014
Title
hippa authorization form 24331
HIPAA Documents
HIPAA Authorization
HIPAA Form
HIPAA_Authorization_Form 2014 24331 new title
HIPAA Authorization Template
Title
24331 ed HIPAA
HIPAA Documents
HIPAA Authorization
HIPAA Form
24331 ed HIPAA
HIPAA Authorization Template
Title
HIppA authorization form 24331 Version 2
HIPAA Documents
HIPAA Authorization
HIPAA Form
24331 ed HIPAA Version 2
HIPAA Authorization Template
Title
Approved_HIppA authorization form 24331 Version 2
HIPAA Documents
HIPAA Authorization
HIPAA Form
Approved_24331 ed HIPAA Version 2
HIPAA Authorization Template
---------------------------------------------------------------------------------------------

IRB Template Date: 3/2014 
 
SAINT LOUIS UNIVERSITY 
 
Research Study Consent Form  
 
 
STUDY TITLE:   
Analysis of hemostatic agents compared to physiologic hemostasis  
 
 
 
This consent form contains important information to help you decide whether to participate in a 
research study. 
 
 
The study staff will explain this study to you.  Ask questions about anything that is not clear at any 
time.  You may take home an unsigned copy of this consent form to think about and discuss with 
family or friends.   
 
 
 Being in a study is voluntary – your choice. 
 If you join this study, you can still stop at any time. 
 No one can promise that a study will help you. 
 Do not join this study unless all of your questions are answered. 
 
 
After reading and discussing the information in this consent form you should know: 
 
 Why this research study is being done; 
 What will happen during the study; 
 Any possible benefits to you; 
 The possible risks to you; 
 Other options you could choose instead of being in this study;  
 How your personal health information will be treated during the study and after the study is over; 
 Whether being in this study could involve any cost to you; and 
 What to do if you have problems or questions about this study. 
 
 
Please read this consent form carefully. 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
1 
 
SAINT LOUIS UNIVERSITY 
 
 
INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
Participant  
 
IRB Number 
24331 
 
Principal 
Investigator (PI) 
Antisdel       Jastin                  MD 
 
PI’s Phone Number 
 
314-577-8885 
 
 
 
    Last 
 
First 
 
Credentials 
 
 
Title of Project: 
Analysis of hemostatic agents compared to physiologic hemostasis 
                                         
 
 
“You” refers to the person who takes part in the research study. 
 
You are being asked to participate in a research study conducted by Dr. Jastin Antisdel and colleagues 
because you have a longstanding sinus infection requiring surgery.  
 
This consent document may contain words that you do not understand.  Please ask Dr. Antisdel or his 
colleagues to explain any words or information that you do not clearly understand. 
  
 
1. WHY IS THIS RESEARCH STUDY BEING DONE? 
The purpose of this research is to compare the effects of six different agents (AristaTM, NexfoamTM, and 
SinufoamTM, Nasopore®, Posisep®, and Posisep®X) when used to stop bleeding after sinus surgery.  
Each agent is FDA approved for this use and has been used extensively.  This study will compare how 
well these agents work as a group from the patient and physician perspective versus no therapy.  This 
will provide knowledge for their future use in patients requiring sinus surgery.  Up to 144 people will be 
enrolled at Saint Louis University. 
 
2. WHAT AM I BEING ASKED TO DO?  
Your participation will involve:  
(1) Having sinus surgery in the standard fashion.  The surgery itself and the post-operative care will be 
no different than if you do not participate (Standard of Care).  The one difference is that at the end of 
your surgery, one sinus will be treated with one product (Research Related). Your surgeon will choose 
the product that is applied to your sinus. An envelope will be selected out of the stack just before the 
surgery and there will be a note inside that states which sinus the material will be applied to.  
 
One of these products (specific product will be chosen by your surgeon) will be placed in one of your 
sinus cavities at the end of surgery and allowed to remain there until it is absorbed or removed at a post-
operative visit on weeks 1, 2, and 6.  This will be done with post-operative irrigations (rinsing the sinus 
cavity) which will remove much of the products (Standard of Care).  If any of this packing still 
remains in your sinus cavity, it will be removed by debridement (removing dead tissue) in the office by 
Dr. Antisdel at a regularly scheduled office visit on weeks 1, 2, and/or 6.  This procedure is standard of 
care and would be done whether or not you participate in this study. 
 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
2 
 
(2) You will provide information about how you are feeling after surgery such as your pain, bleeding, 
blockages, and drainage.  This will be done on post-operative days 1, 2, 7, and 14 (Standard of Care). 
 
(3) You will be given a packet of questionnaires before your surgery.  You will be asked to fill out the 
questionnaires (on days 0, 1, 2, 7, and 14) regarding your experience. These can be returned before your 
surgery and at your regularly scheduled office visits on weeks 1, 2 and 6.  This would not be done if you 
were not in the study (Research Related). 
 
(4) On your normal post-operative visits (weeks 1, 2 and 6) your physician will record information from 
your normal exam.  We will evaluate the differences between the two sides of your sinus cavity for scar 
tissue, swelling, infection, how you are healing, and time needed to remove dead tissue out of your sinus 
cavity (Standard of Care). 
 
 
Questionnaires 
Your participation will involve filling out provided questionnaires. The questionnaires will take 
approximately five minutes each.  The questionnaires do not require your name. They will be stored in 
Dr. Antisdel’s office until all of the surveys have been returned.  The data will then be entered into a 
database with your identifying information removed. 
 
3. HOW LONG WILL I BE IN THE RESEARCH STUDY? 
Your participation in this study is expected to last six weeks.  This is the normal time period for office 
visits after sinus surgery and requires no greater time commitment. 
 
4.  WHAT ARE THE RISKS?   
Your participation in this study will involve both standard of care and research procedures.  The risks 
associated with the standard of care procedure will be discussed with you or, when appropriate, 
addressed in a separate clinical consent document.  
 
There are certain risks and discomforts that may be associated with this research.  They include: 
 
1) Allergic-type Adverse Reaction 
There is a rare possibility of an allergic-type adverse reaction to AristaTM, NexfoamTM, SinufoamTM 
Nasopore®, Posisep®, or Posisep®X.    You may experience itching, hives, hay fever symptoms, 
wheezing, difficulty breathing, and/or new swelling.   These reactions may be serious or life threatening. 
These are the same risks you would have if you did not participate in the study.  
 
There are no other additional adverse reactions to these products associated with being in this study. 
 
2) Breach of Confidentiality 
Information will be kept under lock and key with password protection on the computer.  Coding will be 
used with no patient identifiers attached to confidential information. Even with these precautions, breach 
of confidentiality is a risk. 
 
3) Use of Questionnaire 
Some questions in the questionnaires may make you feel uncomfortable.  You may choose to not answer 
any question that makes you feel uncomfortable. 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
3 
 
4) As with any surgery the risk of bleeding is present, but all precautions will be taken to ensure that 
blood loss is minimal. Also, since material is being placed into your nose there is a risk that this material 
can block your ability to breath through your nose by completing blocking this passage.  As discussed 
earlier any excess material will be removed with postoperative (after the surgery) nasal irrigation. 
Chance of infection will be minimized by postoperative evaluation for signs of infection by Dr. 
Antisdel.  This study is designed to evaluate the utility of materials that are used to lessen bleeding and 
scar tissue formation.  For this reason one side of your nose may heal faster than the other.   
 
5) Pain. The risk of pain exists, as it does for almost any procedure.  Dr. Antisdel will take all 
precaution to ensure that pain (during and after the operation) is minimized. 
 
6) Unknown Side Effects 
There is always the risk of developing previously unknown side effects  
 
Pregnancy/Childbearing Potential 
If you are a woman of childbearing potential, please read and sign below. 
Some research medications or procedures can cause severe birth defects, mental retardation to an unborn baby, 
or loss of the unborn baby.   If you take part in a research study that includes a drug or medical procedure, you 
must be willing to have a pregnancy test done before beginning your participation.  You must avoid becoming 
pregnant while you take part in the research study.   
 
If you are pregnant, or become pregnant, you cannot take part in this research study.  It is important that you let 
the research study doctor know if you are breast-feeding.  If you are pregnant or think you are pregnant, it is 
important for you to let the investigator know immediately.  
  
If you are sexually active during your participation in the research, you will use effective measures (chosen in 
consultation with your health care provider) to avoid becoming pregnant.   
 
Your signature below indicates you agree to these requirements. 
 
Signature                                                                  Date 
 
 
 
You may encounter these risks regardless of participation in this research study. 
 
If side effects or discomforts do occur, Dr. Antisdel will try to minimize and treat these by irrigating the 
treated sinus with salt water to remove the AristaTM, NexfoamTM, SinufoamTM Nasopore®, Posisep®, 
and/or Posisep®X.     
 
The investigator is willing to discuss any questions you might have about these risks and discomforts. 
 
5.  ARE THERE BENEFITS TO BEING IN THIS RESEARCH STUDY? 
You will not benefit from this research study.  Your condition may get better, stay the same or worsen.    
Even though you may not receive any benefit, other people who have sinus surgery may benefit in the 
future because of what the researchers learn from this research study. 
 
6.  WHAT OTHER OPTIONS ARE THERE? 
You may choose not to participate in this research study.  If you choose not to participate in the 
research, then you will have the standard surgical procedure.  The packing used at the end of the surgery 
will be at the surgeon’s discretion.  

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
4 
 
 
7.  WILL MY INFORMATION BE KEPT PRIVATE? 
The results of the research study may be published but your name or identity will not be revealed and 
your record will remain confidential.  In order to maintain confidentiality, Dr. Antisdel or his assistant 
will enter the information from the questionnaires, data sheets, and medical record into a number coded 
spreadsheet.  The database will then be kept on a password-protected computer in a locked office. A 
master list linking the code number and your identity will be kept separate from the research data.  The 
master list will be kept in a locked file and only the principal investigator and designated members of the 
research team will have access to the master list.   
 
The Saint Louis University Institutional Review Board (the Board that is responsible for protecting the 
welfare of research participants recruited to participate in research) and other University officials may 
review your study records. The Food and Drug Administration (FDA) may also review your research 
study records, including your medical record. State laws or court orders may also require that 
information from your research records be released. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law.  This website will not include information that can identify you.  At most, the Web site will 
include a summary of the results.  You can search this website at any time. 
 
8. WHAT ARE THE COSTS AND PAYMENTS? 
Standard of Care to be billed to Insurance 
Because this research provides standard treatment and follow-up tests for the disease or condition being 
studied, insurance carriers ordinarily cover the costs.  You may check with your insurance company to 
verify that they will provide coverage for the care before you agree to participate.  No additional costs 
will be incurred by you or your insurance company by participating in this study.  The study packing 
materials that will be used are part of the total charges for the operation and you will not incur any 
additional charges because a hemostatic material is being used.  You will be responsible for any costs 
not covered by your health insurance company. 
 
You will receive no payment for your participation in this research study.   
 
9.   WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS RESEARCH 
STUDY? 
If you believe that you are injured as a result of your participation in the study, please contact the 
Principal Investigator and/or the Chairperson of the Institutional Review Board as stated in section 10. 
 
The University will provide medical treatment in the event that an injury results because of your 
participation in this research; however, the University reserves the right to make decisions concerning 
payment for medical treatment for injuries solely and directly relating to the research. The University 
makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting 
from participation in this research.   You have not waived your legal rights by signing this form.  If you 
have questions, please call the Saint Louis University General Counsel’s office at 314-977-5767. 
 
 
10.  WHO CAN I CALL IF I HAVE QUESTIONS? 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
5 
 
If you have any questions or concerns regarding this study, or if any problems arise, you may call the 
Principal Investigator Dr. Antisdel at 314-577-8885.  For questions after hours, you may call 314-577-
8000 and ask for the ENT resident on call. 
 
If you have any questions about your rights as a research participant or in the event you believe you 
have suffered an injury as a result of participation in the research project, you may contact the 
Chairperson of the Saint Louis University Biomedical Institutional Review Board (314-977-7744), who 
will discuss your questions with you or will be able to refer you to the individual who will review the 
matter with you, identify other resources that may be available to you, and provide further information 
as how to proceed. 
  
 
11.  WHAT ARE MY RIGHTS AND WHAT ELSE SHOULD I KNOW AS A RESEARCH 
STUDY VOLUNTEER?  
Your participation in this research is voluntary and refusal to participate will involve no penalty to you 
or loss of any benefits to which you are otherwise entitled. You may withdraw from the research study 
at any time without penalty or loss of benefits to which you are otherwise entitled. You will be informed 
of any significant new findings developed during the course of participation in this research that may 
have a bearing on your willingness to continue in the study.  The investigator may withdraw you from 
this research if circumstances arise which makes this necessary. 
 
The investigator may terminate your participation even without your consent when, in the investigator’s 
judgment, it is in your interest to do so, or under certain circumstances:  
 Conditions worsen or do not improve and an alternative treatment is medically indicated,  
 A side effect or medical condition occurs that may place you at risk of further 
complications if study participation is continued,  
 Inability to take the medication /participate as instructed,  
 Inability to keep scheduled appointments, 
 Cancellation by the regulatory agency 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
6 
 
12.  AM I SURE THAT I UNDERSTAND?  
I have read this consent document and have been able to ask questions and express concerns, which have 
been satisfactorily responded to by the investigator(s).  I have been asked if I wish to speak directly to 
the researcher or research study doctor responsible for this research study. I believe I understand the 
purpose of the study as well as the potential benefits and risks that are involved.   
 
Statement of Consent 
 
I give my informed and voluntary consent to be a participant in this study. I will be given a signed copy 
of this consent document for my records.  
 
__________________________________                           ________________ 
Consent Signature of Research Participant (18 and over)     Date  
                                            
 
___________________________________ 
Print Name of Participant 
 
 
 
SAINT LOUIS UNIVERSITY – INSTITUTIONAL REVIEW BOARD – APPROVAL STAMP 
 
This form is valid only if the IRB’s approval stamp is shown below. 
 
 
 
I certify that I have explained to the above individual(s) the nature and purpose of the study and 
the possible benefit and risks associated with participation.   I have answered any questions that 
have been raised and the subject/patient has received a copy of this signed consent document. 
 
________________________________ 
 
_______________ 
Signature of Principal Investigator  
 
Date  
or Research Team Member  
 
 
 
 
 
 
 
 
________________________________________ 
Print Name of Principal Investigator or  
Research Team Member 
 
IRB #: 24331 
Approved: 03-07-17 
Expires: 03-31-18 
Board #: 1 
Saint Louis University
 
 

Biomedical IRB Template Date: 3/2014 
 
Version Date: 
 
7 
 
NOTE: The Principal Investigator or Research Team Member that signs 
here must be authorized in the IRB-approved protocol to obtain informed 
consent and must sign at the SAME time on the same day as the above 
signatures are obtained.