Clinical trial NCT03401749
Conditions: Surgical Site Infection
Sponsor: University of Alabama at Birmingham
Start date: 2018-11-01; Completion date: 2020-12-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes

Study Design: Single center RCT

Sample Size: 500 patients, aged 18+

Objectives: Primary Objectives:

1. Monitor for safety and adverse effects.
2. Evaluate for differences in peri-operative skin cultures between treatment groups;
3. Compare surgical site infection rates between groups.

Secondary Objectives:

1. Assess for patient compliance for each different treatment arms.
2. Measure patient satisfaction.
3. Measure nurse satisfaction.
4. Visual assessment of wound healing

Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.

Detailed description:

Arms: arm 1: Usual preadmission surgery instructions (shower the night before). arm 2: Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. arm 3: Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.
Interventions: intervention 1: Chlorhexidine Gluconate 2% Wipe intervention 2: Theraworx Bath Wipes
Intervention descriptions: intervention 1: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. intervention 2: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6.

Protocol documents:
ICF_002.pdf: 
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery
Patients
NCT03401749
Last updated 2/23/18
A prospective observational cohort study
Contributing Authors:
Eva Lehtonen1
Orthopaedic Research Fellow
Sam Huntley1
Medical Student
Andrew Moon1
Medical Student
Sameer Naranje1
Joint Surgeon, Department of Orthopaedics
Gerald McGwin, PhD1,2,
Statistician
Ashish Shah, MD1, (ashishshah@uabmc.edu)
Foot and Ankle Surgeon, Primary Investigator
1Department of Orthopaedic Surgery, University of Alabama at Birmingham; Birmingham, AL
2Department of Epidemiology, University of Alabama at Birmingham; Birmingham, AL
Corresponding Author:
Ashish Shah, M.D.
Associate Professor, Director of Clinical Research
Department of Orthopaedic Surgery
1313 13th Street South, Suite 226
Birmingham, AL 35205


CONSENT FORM
TITLE OF RESEARCH: Efficacy of Preadmission TheraworxTM Wipe Use for
Skin Decolonization and Surgical Site Infection Prophylaxis in Adult
Orthopedic Surgery Patients: A Randomized Controlled Trial
IRB PROTOCOL NO.:
IRB-300000508
PRINCIPAL INVESTIGATOR:
Ashish Shah, M.D.
Purpose of the Research
We are asking you to take part in a research study. This research study will test
how the addition of TheraworxTM wipes or Chlorhexidine Gluconate (CHG)
wipes to our standard pre- operative skin preparation effect the colonization
rate of many bacteria. These bacteria are among the most common causes of
surgical site infections after orthopedic surgeries. This study will also test how
the addition of TheraworxTM wipes or Chlorhexidine Gluconate (CHG) wipes
effects the rate of surgical site infections. We will instruct you how to use the
wipes and provide you the wipes to use at home the evening before surgery.
We will also provide and administer the wipes on the site of the surgery before
the procedure begins. There is literature supporting that the use of
TheraworxTM or CHG wipes lowers the rate of skin colonization. This is a
randomized prospective study and will enroll 500 participants; all of them will
come from UAB orthopaedic clinics.
Explanation of Procedures
If you enter the study, you will be placed in one of three groups:
1. One group will receive a standard skin preparation before your surgery.
This group is the control group and will undergo orthopedic surgery
following UAB’s standard guidelines.
2. Another group will be given 2% Chlorhexidine Gluconate (CHG) wipes
to take home during your last visit before the surgery. You will be given
thorough instructions on how to administer the wipes the night before
the surgery. Then, a nurse will use the wipe on you one hour before
your standard pre-operative skin preparation on the day of the surgery.
3. The last group will be given TheraworxTMwipes to take home during
your last visit before the surgery. You will be given thorough
instructions on how to administer the wipes the night before the
surgery. Then, a nurse will use the wipe on you one hour before
your standard pre-operative skin preparation on the day of the
surgery.


Risks and Discomforts
There may be a small chance of breach of confidentiality as a result of electronic information
being hacked or stolen. You will be assigned to a group by chance, which may prove to be less
effective or to have more side effects than the other study group or alternatives. Some patients
may experience mild skin irritation or redness on the application site. Up to 10% may
experience dryness, itching, or rash on the application site. Very rarely (less than 1% of
patients), patients may experience a serious allergic reaction within minutes after the
application of the wipe. Please inform your treatment team if you have ever experienced an
allergic reaction to CHG or any other skin product. Symptoms of severe allergic reaction include
wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more
serious symptoms; severe body rash; or shock, which is a life-threatening condition that occurs
when the body is not getting enough blood flow. If you experience these symptoms seek
medical attention immediately.
Benefits
If you are in the group not receiving the topical wipe, you may not directly benefit from taking
part in this study. However, this study may help us better understand how to decrease the
positive colonization rate in the general population undergoing similar surgeries and maybe
decrease post-surgical complications caused by bacterium. This study may also help raise the
awareness for future investigations and possibly provide an updated option on standard skin
preparation for orthopaedic surgeries.
Alternatives
Your alternative is not to participate in the study.
Confidentiality
Information obtained about you for this study will be kept confidential to the extent allowed by
law. However, research information that identifies you may be shared with the UAB Institutional
Review Board (IRB) and others who are responsible for ensuring compliance with laws and
regulations related to research, including people on behalf of Dr. Ashish Shah and the Office for
Human Research Protections (OHRP). The information from the research may be published for
scientific purposes; however, your identity will not be given out. This consent document will be
placed in your file at UAB Hospital facility. The document will become part of your medical
record chart.
Your consent form will be placed in your medical record at UAB Health System or Children’s of
Alabama. This may include either a paper medical record or electronic medical record (EMR).
An EMR is an electronic version of a paper medical record of your care within this health


system. Your EMR may indicate that you are on a clinical trial and provide the name and
contact information for the principal investigator.
If you are receiving care or have received care within this health system (outpatient or
inpatient) and are participating in a research study, results of research tests or procedures (i.e.
laboratory tests, imaging studies and clinical procedures) may be placed in your existing
medical record.
If you have never received care within this health system (outpatient or inpatient) and are
participating in a research study, a medical record will be created for you to maintain results of
research tests or procedures.
Results of research tests or procedures may be placed in your medical record. All information
within your medical record can be viewed by individuals authorized to access the record.
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
website will include a summary of the results. You can search this website at any time.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide
not to be in the study. If you decide not to be in the study, you will not lose any benefits you are
otherwise owed. You are free to withdraw from this research study at any time. Your choice to
leave the study will not affect your relationship with this institution.
You may be removed from the study without your consent if the sponsor ends the study, if the
study doctor decides it is not in the best interest of your health, or if you are not following the
study rules.
If you are a UAB student or employee, taking part in this research is not a part of your UAB class
work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the study
is over, with no effect on your class standing, grades, or job at UAB. You will not be offered or
receive any special consideration if you take part in this research.
Cost of Participation
There will be no cost to you for taking part in this study. The costs of your standard medical
care will be billed to you and/or your insurance company in the usual manner.
Payment for Participation in Research
You will not be paid for taking part in this study.


Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this study.
If such harm occurs, treatment will be provided. However, this treatment will not be provided
free of charge.
Questions
If you have any questions, concerns, or complaints about the research or a research-related
injury including available treatments, you may contact Dr. Ashish Shah. He will be glad to
answer any of your questions. Dr. Shah’s number is 205-930-6722.
If you have questions about your rights as a research participant, or concerns or complaints
about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll
free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday
through Friday. You may also call this number in the event the research staff cannot be reached
or you wish to talk to someone else.
Legal Rights
You are not waiving any of your legal rights by signing this informed consent document.
Signatures
Your signature below indicates that you have read (or been read) the information provided
above and agree to participate in this study. You will receive a copy of this signed consent form.
Signature of Participant
Date
Signature of Principal Investigator or Person Obtaining Consent
Date


University of Alabama at Birmingham
AUTHORIZATION FOR USE/DISCLOSURE OF
PROTECTED HEALTH INFORMATION (PHI) FOR RESEARCH
Participant Name:
UAB IRB Protocol Number: IRB-300000508
Research Protocol: Efficacy of Preadmission TheraworxTM Wipe Use
for Skin Decolonization and SSI Prophylaxis in Adult Orthopedic Surgery
Patients: A Randomized Controlled Trial
Principal Investigator:
Ashish Shah, MD
Sponsor: Dept. of Surgery, Division of Orthopaedics
What is the purpose of this form? You are being asked to sign this form so that UAB may use and release your
protected health information for research. Participation in research is voluntary. If you choose to participate in the
research, you must sign this form so that your protected health information may be used for the research.
Why do the researchers want my protected health information? The researchers want to use your protected
health information as part of the research protocol listed above and as described to you in the informed consent.
What protected health information do the researchers want to use? All medical information, including but not
limited to information and/or records of any diagnosis or treatment of disease or condition, which may include
sexually transmitted diseases (e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal
identifiers, including but not limited to your name, social security number, medical record number, date of birth,
dates of service, etc.; any past, present, and future history, examinations, laboratory results, imaging studies and
reports
and
treatments
of
whatever
kind,
including
but
not
limited
to
drug/alcohol
treatment,
psychiatric/psychological treatment; financial/billing information, including but not limited to copies of your
medical bills, and any other information related to or collected for use in the research protocol, regardless of
whether the information was collected for research or non-research (e.g., treatment) purposes.
Who will disclose, use and/or receive my protected health information? All Individuals/entities listed in the
informed consent documents, including but not limited to, the physicians, nurses and staff and others performing
services related to the research (whether at UAB or elsewhere); other operating units of UAB, HSF, UAB Highlands,
Children’s of Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as necessary for
their operations; the IRB and its staff; the sponsor of the research and its employees and agents, including any CRO;
and any outside regulatory agencies, such as the Food and Drug Administration, providing oversight or performing
other legal and/or regulatory functions for which access to participant information is required.
How will my protected health information be protected once it is given to others? Your protected health
information that is given to the study sponsor will remain private to the extent possible, even though the study
sponsor is not required to follow the federal privacy laws. However, once your information is given to other
organizations that are not required to follow federal privacy laws, we cannot assure that the information will
remain protected.
How long will this Authorization last? Your authorization for the uses and disclosures described in this
Authorization does not have an expiration date.
Can I cancel this Authorization? You may cancel this Authorization at any time by notifying the Principal
Investigator, in writing, referencing the research protocol and IRB Protocol Number. If you cancel this Authorization,
the study doctor and staff will not use any new health information for research. However, researchers may
continue to use the protected health information that was provided before you cancelled your authorization.
Can I see my protected health information? You have a right to request to see your protected health information.
However, to ensure the scientific integrity of the research, you will not be able to review the research information
until after the research protocol has been completed.
Signature of participant:
Date:
or participant's legally authorized representative:
Date:
Printed Name of participant’s representative:
Relationship to the participant:
Page 5 of 5
Version Date: 02/16/18



Prot_000.pdf: 
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery
Patients
NCT03401749
Last updated 4/23/20
A prospective observational cohort study
Contributing Authors:
Eva Lehtonen
Orthopaedic Research Fellow
Sam Huntley
Medical Student
Andrew Moon
Medical Student
Sameer Naranje
Joint Surgeon, Department of Orthopaedics
Gerald McGwin, PhD1,2,
Statistician
Ashish Shah, MD1, (ashishshah@uabmc.edu)
Foot and Ankle Surgeon, Primary Investigator
1Department of Orthopaedic Surgery, University of Alabama at Birmingham; Birmingham, AL
2Department of Epidemiology, University of Alabama at Birmingham; Birmingham, AL
Corresponding Author:
Ashish Shah, M.D.
Associate Professor, Director of Clinical Research
Department of Orthopaedic Surgery
1313 13th Street South, Suite 226
Birmingham, AL 35205


Human Subjects Protocol (HSP)
Form Version: July 29, 2019
∙To avoid delay, respond to all items in order and include all required approvals and documents. For more tips, see the UAB IRB website. ∙To
complete the form, click the underlined areas and type or paste in your text; click checkboxes to check/uncheck. ∙All responses should be
Times New Roman, Bold, and Underlined.
∙NOTES REGARDING VA RESEARCH: BVAMC research cannot be reviewed by an external IRB (only UAB IRB). Ensure you complete this form for any
BVAMC research. BVAMC Research must be signed off by the BVAMC supervisor for scientific/scholarly review via PORF prior to submission of this
form.
INDICATE THE TYPE OF REVIEW YOU ARE APPLYING FOR:
☒Convened (Full) IRB
OR
☐Expedited - See the Expedited Category Review Sheet, and indicate the category(ies)
here: ☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7
1. IRB Protocol Title: Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in
Adult Orthopedic Surgery Patients: A Randomized Controlled Trial
2. Investigator and Contact Person
a. Name of Principal Investigator: Ashish Shah
Degree(s)/Title: MD BlazerID: ashpurvi
Dept/Div: Surgery/Orthopoedics Mailing Address: 1313 13th St S UAB ZIP: 35205 Phone: (205)
930-6722 E-mail: ashishshah@uabmc.edu
b. Name of Contact Person: Hina Amanullah Title: Regulatory Coordinator Phone: 205-934-3796
E-mail: hkaman01@uab.edu
INVESTIGATOR ASSURANCE STATEMENT & SIGNATURE
By my signature as Principal Investigator, I acknowledge my responsibilities for this Human Subjects Protocol, including:
∙Certifying that I and all key personnel comply with reporting requirements of the UAB Conflict of Interest Review
Board;
∙Certifying that the information, data, and/or specimens collected for the research will be used, disclosed and
maintained in accordance with this protocol and UAB policies;
∙Following this protocol without modification unless (a) the IRB has approved changes prior to implementation or (b) it  is
necessary to eliminate an apparent, immediate hazard to a participant(s);
∙Verifying that all key personnel listed on the submission have completed initial IRB training and will complete
continuing IRB training as required;
∙Verifying that all personnel are licensed/credentialed for the procedures they will be performing, if applicable; ∙
Certifying that I and all key personnel have read the UAB Policy/Procedure to Ensure Prompt Reporting of
Unanticipated Problems Involving Risks to Subjects or Others to the IRB, Institutional Officials, and Regulatory
Agencies and understand the procedures for reporting;
∙Applying for continuing review of the protocol at least annually unless directed by the IRB to apply more frequently; ∙
Conducting the protocol as represented here and in compliance with IRB determinations and all applicable local,  state,
and federal law and regulations; providing the IRB with all information necessary to review the protocol;  refraining
from protocol activities until receipt of initial and continuing formal IRB approval.
Signature of Investigator: Date:


FOR 200 Revised 4/23/2020 Page 1 of 16 07/29/19
3. Protocol Personnel
a. Complete the IRB PERSONNEL FORM to list all key personnel (each individual involved in the design and conduct of this protocol).
b. Non-UAB Personnel Relying on UAB IRB - If you are requesting that the UAB IRB serve as the IRB of record for any non-UAB personnel, list
these individuals below. Add additional rows as necessary.
Name and Degree
From Institution with or without own IRB?
Financial Interest?*
Protocol Responsibilities
and Qualifications
(indicate if this person
obtains consent)
Name:
Degree:
Institution:
Email:
☐Has own IRB but requests that UAB
IRB  serve as IRB of record?-OR-
☐Does not have own IRB and needs to
rely  on UAB IRB.
☐No
☐Yes
* If the individual has a Financial Interest, include a copy of the report from his/her own institution’s conflict of interest review with this submission
to the UAB IRB.
VA Personnel: The VA Financial Conflict of Interest (fCOI) form must be submitted to the VA fCOI Committee Chair. Include in 3.a above any
financial conflict of interest as submitted on that VA fCOI form. If there is a conflict, submit a copy of the management plan with this submission.
c. Are any of the investigators listed on the IRB PERSONNEL FORM students using this research for their thesis or
dissertation? ☐Yes ☒No If No, continue with Item 3d.
If Yes, provide the name of the student and the Thesis/Dissertation Title:
d. Is the principal investigator a student, fellow, or resident? ☐Yes ☒No If Yes, complete items below and
obtain signature of faculty advisor or supervisor:
Supervisor’s Name:
Supervisor’s Signature:_____________________________________________
e. Is medical supervision required for this research? ☐Yes ☒No If Yes, who will provide the medical
supervision?
☐PI will provide -OR-
☐Other:
Name: Telephone:
If other than PI, obtain signature of person providing medical supervision:
Signature
f. Describe the principal investigator's activities related to this protocol and provisions made by the PI to devote
sufficient time to conduct the protocol: He played a primary role in the development of this protocol in its
entirety. Dr. Shah will make sure that patients in the three different groups receive the correct skin
preparation and will perform the foot and ankle surgeries to patients in this study. He will devote a
minimum of two hours per week to oversee the progress during different phases of the project: protocol
troubleshooting, patient enrollment, procedures, and data collection/analysis. Many of these
responsibilities fall within existing scope of clinical practice. Time is set aside each week on Tuesday
afternoons and Fridays for all other research related activities, such as IRB paperwork, study design,
data handling, and manuscript preparation


g. Describe your process for ensuring all key personnel are adequately informed about the protocol and their
research-related duties and functions:
Each person involved in this project is in complete understanding of the protocol and contributed to
make the project safer for patients and more efficient. Each person will attend meetings scheduled by
the PI to discuss their progress in their role. Each person has read these IRB forms throughout and
authorized their understanding. Study personnel are briefed/instructed verbally on their research
related duties prior to involvement in the study. Instructional documentation for study personnel will
FOR 200 Revised 4/23/2020 Page 2 of 16 07/29/19
also be provided to all individuals carrying out key study functions, and copies will be made available
and stored in the Highlands clinic or OSI offices. Instructional documentation will include patient
recruiting instructions/materials, inclusion/exclusion criteria; consent documentation, patient education
materials, product storage, handing, and distribution instructions, preoperative nursing instructions,
clinic follow-up instructions, and workflow diagrams.
4. Funding
Is this protocol funded? ☐Yes ☒No
If No, specify that costs of the protocol will be covered by funds from the UAB department or other source
named: The costs of the products being compared (Theraworx bath wipes and Chlorhexidine bath wipes)
will be covered by the UAB department of surgery, orthopedic surgery division. Patients will be responsible
for the cost of their own bathing (soap and water). Participants will be financially responsible for their
medical care, including clinic visits and surgeries, to the same extent as if they chose not to participate in
the trial. Study participants will be responsible for the cost of any additional medical care related to serious
adverse reactions to the products used in the study. Participants are made aware of their financial
responsibilities in the consent form.
If Yes, attach one copy of completed application or request for funding sent to sponsor, and complete a-d.
a. Title of Grant, Contract, or Agreement:
b. UAB PI of Grant, Contract, or Agreement:
c. Office of Sponsored Programs (OSP) Assigned Number:
(If not yet available, enter “Pending” and provide upon receipt from OSP.)
d. Sponsor, Funding Route:
(Check and describe all that apply)
(If subaward, list both the funding source and the institution receiving the direct award)
☐Gov’t Agency or Agencies—Agency name(s):
☐Department of Defense (DoD): Identify DoD component:
☐Department of Energy (DOE)
☐Department of Justice (DOJ)
☐Department of Education
☐NIH Cooperative Group Trial - Group name:
☐Private Nonprofit (e.g., Foundation) - Name:
☐Industry-sponsored, industry-initiated - Name:
NOTE: The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or
when the protocol qualifies for expedited review or involves gene therapy.
☐Industry-sponsored, investigator-initiated - Name:
Describe the funding arrangement:
NOTE: The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or
when the protocol qualifies for expedited review or involves gene therapy.


☐UAB Departmental/Division Funds—Specify:
☐VA Funding —Specify:
5. Locations Involved
a. Indicate all performance sites that will provide space, services, or facilities for the conduct of this protocol.
☒UAB Hospital
☒UAB Hospital - Highlands
☐The Kirklin Clinic of UAB Hospital
☐The Kirklin Clinic at Acton Road
FOR 200 Revised 4/23/2020 Page 3 of 16 07/29/19
☐UAB Callahan Eye Hospital
☐UAB Clinical Research Unit
☐Children's of Alabama
☐Birmingham Veterans Affairs Medical Center NOTE: Research may only be conducted by investigators who
have a BVAMC appointment
☐Jefferson County Department of Health
☒Other (i.e., any performance site not listed above, including those covered by subawards related to this
protocol) - Describe: UAB Orthopedic Specialties Institute (OSI)
NOTE: Documentation of IRB approvals from sites receiving subawards must be received by the UAB OIRB
before funding will be released for that subaward.
b. Describe the space, service, or facilities available for the conduct of the research in the performance sites
listed in Item 5.a (For research on UAB campus, include building names): UAB Hospital Highlands will
serve as the primary site for the carrying out of research activities. Patients will be recruited, examined,
and followed in the Highlands orthopedic clinics. In addition, patients will receive their pre-operative
and surgical care primarily at this site. Patient recruitment, consent, and group allocation
documentation will be stored primarily in the Highlands Clinics. Theraworx and CHE bathwipes and
nursing and OR personnel instructions will also be stored and distributed at this site. The Orthopedic
Specialties Institute (OSI) is located across the street from UAB Highlands and serves as the location of
many key personnel offices, including the PI and administrative support staff. OSI will serve as
additional office space for the storage of excess research documentation, and will function as the
primary location for the sending and receiving of fax communication related to this research project. In
addition, OSI serves as a primary site for research meetings among study personnel to discuss study
progress, voice concerns, delineate responsibilities, and discuss reporting of results and manuscript
preparation.
UAB Hospital will serve as an additional study site. Orthopedic colleagues from this site may recruit
patients for this study, and some procedures may be performed at the UAB main hospital. In addition,
if any study patient requires care that can only be provided at UAB Hospital, care will be transferred to
this location.
c. Does this protocol require clinical services at one of the sites listed in Item 5.a above? ☐Yes ☒No If Yes, will
any of the services be billed to either participants/their insurance or to the study account through  the
Hospital Billing Office (PFS) or the HSF Billing Office (MSO)? ☐Yes ☒No
If Yes, submit a Fiscal Approval Process (FAP)-designated unit submission and send to fap@uab.edu. For
more on the UAB FAP requirements, go to FAP - SiteMinder Processes.
d. Is this a field study? ☐Yes ☒No If Yes, describe the community and include information about how the
community will be involved in the  design, implementation and analysis of the research. This would
include focus groups, training local  facilitators/community health advisors:
e. Has this protocol been rejected or disapproved by another review board (another IRB, similar review board, or


departmental review committee(s)) that authorizes the use of its patient populations? ☐Yes ☒No
If Yes, provide name(s) of the review board(s) and reason(s) not approved:
Attach copies of the disapprovals.
NOTE: If this protocol is subsequently rejected or disapproved by another review board, promptly notify UAB
IRB.
f. Will the protocol be conducted at or recruit participants from the Birmingham Veterans Affairs Medical Center
(BVAMC)? ☐Yes ☒No If Yes, describe the involvement of the BVAMC:
FOR 200 Revised 4/23/2020 Page 4 of 16 07/29/19
Attach the BVAMC consent form(s), if applicable. Attach any other applicable BVAMC forms (such as the
Privacy and Information Security Checklist and The BVAMC FCOI forms).
NOTE: Investigators conducting research at BVAMC must have a BVAMC appointment.
NOTE: See the BVAMC section of the IRB Guidebook for more information.
g. Will the protocol be conducted at or recruit participants from the Jefferson County Department of Health
(JCDH)? ☐Yes ☒No If Yes, describe the involvement of the JCDH and list the JCDH clinics being used:
Attach the JCDH Research Review Panel approval, if applicable.
NOTE: Human subjects research conducted at certain JCDH clinics requires review by the JCDH Research
Review Panel. See the JCDH section of the IRB Guidebook for more information.
6. Clinical Trial
Does this protocol meet the following definition of a clinical trial? ☒Yes ☐No *A research study in which one or
more human subjects are prospectively assigned to one or more interventions (which may include placebo or
other control) to evaluate the effects of those interventions on health-related biomedical or behavioral
outcomes. For more information, see the full definition of clinical trial here. If Yes, you will need to fulfill the
following requirements (regardless of funding):
a. All key personnel must complete the Good Clinical Practices (GCP) training. For information on this
requirement, visit the IRB website here.
b. This protocol must be registered on ClinicalTrials.gov. Provide the National Clinical Trial (NCT) identifier
number: NCT03401749
If you have any questions regarding registering a study on ClinicalTrials.gov, email the UAB Center for Clinical
and Translational Science at ccts@uab.edu.
7. Multi-Site Studies
a. Is this a multi-site study? ☐Yes ☒No b. Is the UAB Investigator the lead investigator? ☐Yes ☒No c. Is this
a multi-site study with a coordinating site? ☐Yes ☒No d. Is this a multi-site study with UAB as a
coordinating site? ☐Yes ☒No
If Yes to a, b, c, or d, describe the management of information obtained in multi-site research that might be
relevant to the protection of participants:
Include, at a minimum, how the following items are managed: IRB approvals from other sites; Unanticipated
problems involving risks to participants or others. (For example, if there is an unanticipated problem involving
risks to participants or others, which site is responsible for reporting it?); Interim result; & Protocol
modifications.
8. Drugs
Will any drugs or supplements be used or studied in this protocol? ☒Yes ☐No If Yes, attach the completed
Drug Review Sheet.
If BVAMC, attached the completed BVAMC Drug Review Sheet .


9. Devices
a. Will any devices be studied in this protocol? ☐Yes ☒No
b. Will any not FDA-approved devices be used or studied in this protocol? ☐Yes ☒No If Yes to a or b, attach
the completed Device Review Sheet.
10. Special Approvals
a. Does this protocol involve the use of radioisotopes? ☐Yes ☒No
FOR 200 Revised 4/23/2020 Page 5 of 16 07/29/19
If Yes, attach documentation of approval from the Radiation Safety Division.
b. Does this protocol include patients with contagious infections (e.g., mumps, measles, chickenpox, TB,
meningitis)? ☐Yes ☒No If Yes, attach documentation of approval from the Infection Control Committee of
the appropriate facilities.
c. Does this protocol involve obtaining remnant biopsy or surgical material from the Department of Pathology or
any other source? ☐Yes ☒No If Yes, attach documentation of approval from the entity or individual providing
the materials (e.g., the UAB Division of Anatomic Pathology Release of Pathologic Materials).
d. Does this protocol require obtaining any remnant clinical laboratory biospecimens, body fluids, or
microbiological isolates from the Department of Pathology or any other source? ☐Yes ☒No If Yes, attach
documentation of approval from the entity or individual providing the materials (e.g., the UAB Division of
Laboratory Medicine Release of Pathologic Materials).
e. Does this protocol use stored (existing) biospecimens from a repository? ☐Yes ☒No If Yes, attach
documentation of approval for use of biospecimens, and describe how existing biospecimens  are labeled:
11. Use of Biospecimens
Does this protocol involve the collection of biospecimens? ☐Yes ☒No If Yes, complete 11.a-11.h.
If No, skip to Item 12.
a. How will biospecimens be obtained, processed, distributed, and stored?
b. How will biospecimens be labeled (e.g., unique identifier, medical record number, Social Security number,
name, date of birth)?
c. How will clinical data associated with the biospecimens be collected and stored?
d. What participant-identifying information will be collected and linked to the biospecimens?
e. What steps will be taken to maximize the confidentiality of linked identifiers? For example, procedures
could include using a password-protected computer database to link identifiers, with limited personnel
knowledgeable of the password, or coded identifiers released without the ability to link to clinical data (also
called “stripped” or “anonymized” biospecimens).
f. Is genetic testing planned as part of this protocol? ☐Yes ☐No If Yes, describe the planned genetic testing
here.
i. Does this include whole genome sequencing? ☐Yes ☐No ii. Will participants be informed of the
results of any DNA testing? ☐Yes ☐No
g. Will biospecimens be stored for future use? ☐Yes ☐No If Yes, indicate whether they will be used for the
disease under study in this protocol or research on other  diseases. In addition, indicate where the
biospecimens will be banked
∙If above is a BVAMC location, what IRB is responsible for overseeing the operations of the
biospecimens bank (i.e., local IRB or other multi-site or central IRB?)


h. Will biospecimens be shared with other investigators in the future? ☐Yes ☐No i. What identifiers, clinical
information and demographic information will be shared; or will the  biospecimens be stripped of identifiers
(i.e., anonymized)?
FOR 200 Revised 4/23/2020 Page 6 of 16 07/29/19
NOTE: Coding data is not considered anonymous.
ii. Outline your procedure for assuring IRB approval for release and use prior to release of
biospecimens.
NOTE: Investigators who receive and/or use these biospecimens must document approval from the
appropriate IRB(s) before the biospecimens may be released.
i. Will specimens be destroyed after the project-specific use is completed? ☐Yes ☐No j. Will specimens be
used and/or shared for commercial profit? ☐Yes ☐No k. Will specimens be destroyed after the
project-specific use is completed? ☐Yes ☐No
l. Will participants be informed of the results of the specimen testing? ☐Yes ☐No m. Are there any
implications for family members based on specimen testing results? ☐Yes ☐No (If yes, the family members
may be participants.)
12. Gene Therapy
Does this protocol involve gene therapy or administering recombinant materials to humans? ☐Yes ☒No If
Yes, submit the Gene Therapy Project Review Panel Report -OR- the Protocol Oversight Review Form For
Clinical Vaccine Trials, as applicable.
13. HIPAA Privacy and Security
Will the PI or others obtain, review, or make other use of participants' “protected health information” (i.e.,
information, whether oral or recorded in any form or medium that (a) is created or received by a health care
provider and (b) relates to past, present, or future physical or mental health or condition of an individual; or
provision of health care; or payment for provision of heath care)? ☒Yes ☐No If Yes, complete Items
13.a-13.f.
If No, skip to 14.
a. Will the data/information be stored or managed electronically (on a computer)?
☒Yes ☐No
b. Is the principal investigator requesting that the UAB IRB waive patient HIPAA authorization from another
institution or entity (e.g., insurance company, collaborating institution)? ☐Yes ☒No If Yes, attach copies
of the privacy notices from each institution/entity, and provide the name of each  institution/entity:
c. Indicate which of the entities would provide health information for this protocol, maintain health information
as it was collected for this protocol, and/or store health information after it has been collected for this
protocol.
☒UAB Hospital or UAB Hospital - Highlands
☐The Kirklin Clinic of UAB Hospital or Acton Road (and/or associated clinics)
☐UAB Callahan Eye Hospital
☐Children's of Alabama
☐Jefferson County Department of Health
☐School of Dentistry
☐School of Health Professions
☐School of Medicine


☐School of Nursing
☐School of Optometry
☐University of Alabama Health Services Foundation
☐UAB Health Centers
FOR 200 Revised 4/23/2020 Page 7 of 16 07/29/19
☐Viva Health
☐Ophthalmology Services Foundation
☐Valley Foundation
☐Medical West - UAB Health System Affiliate
☐Birmingham Veterans Affairs Medical Center
☐None - If None, skip to Item 14.
d. Indicate any information systems that will be the sources of information used for the protocol. ☒A system
maintained centrally by UAB Health System (these include the following: HealthQuest for  registration,
billing, and patient administration; PowerInsight (clinical data warehouse); Cerner IMPACT for PowerNotes
for meds, Lab, Radiology, UED, Surgery
NOTE: If a researcher needs information in a specified format or a specified time, the researcher must
confirm with the unit who can supply the information/service that the request can be met before writing
the information/service into the research protocol. In addition, the researcher must be aware that these
services may have a cost attached that should be considered in the research budget.
To request access to clinical systems for research purposes, visit
https://www.oneuabmedicine.org/web/hsis/technical-support, click “Accounts Request” and complete
the form indicating access for research purposed.
☐Another system on a UAB or BVAMC server - Describe:
e. Indicate which of the listed identifiers will be accessed, associated and/or linked with the protected health
information (PHI) used for this protocol.
☒Names
☐Geographic subdivisions smaller than a state
☒Elements of dates (except year) related to an individual
☐Telephone numbers
☐Fax numbers
☐Email addresses
☐Social security numbers
☒Medical record numbers
☐Health plan beneficiary numbers
☐Account numbers
☐Certificate/license numbers
☐Vehicle identifiers and serial numbers
☐Device identifiers and serial numbers
☐Biometric identifiers
☐Web universal resource locators (URLs)
☐Internet protocol address numbers
☐Full-face photographic images
☐Any other unique identifying number - Describe:
NOTE: Codes are not identifying as long as the researcher cannot link the data to an individual
☐None - If None, skip to Item 14.


f. Choose one plan to describe your use of the personal health information:
☐The data collected meet the specifications for a “limited data set” (LDS)
-If the LDS will leave the covered entity or will be received from another covered entity you will need a
Data Use Agreement
☒Research staff will obtain authorization from each participant to use the information
FOR 200 Revised 4/23/2020 Page 8 of 16 07/29/19
-Include the HIPAA Authorization form, complete except for participant name and IRB protocol number,
as the final page of the consent form
☐PI requests waiver of authorization to use the information
-Attach Waiver of Authorization and Informed Consent form
NOTE: For BVAMC research, the BVAMC HIPAA authorization form or UAB HIPAA waiver form must be
completed and submitted with the HSP.
PROPOSED RESEARCH
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the items as outlined below. •
Do not separate responses from items. Instead, insert your response to each item below the item, keeping the
information in the order of this form.
14. Purpose - in nontechnical, lay language
a. Summarize the purpose and objectives of this protocol in one short paragraph.
The purpose of this protocol is to assess the effect of the addition of 2 doses of 2% topical chlorhexidine
gluconate wipes or topical TheraworxTM wipes to standard ChloroPrep skin preparation on patients
undergoing orthopedic surgery procedures. Our objective is to test the hypothesis that administration of
2% topical chlorhexidine gluconate or topical TheraworxTM wipes (one dose the night before surgery
and one on the day of surgery) will reduce the number of surgical site infections in patients undergoing
orthopedic surgery procedures. Furthermore, we will explore whether the rate of surgical site infections
from patients who utilized 2% topical chlorhexidine gluconate wipes significantly differs from those
who utilized topical TheraworxTM wipes. We hope to reduce the rate of surgical site infections with this
intervention.
b. Describe how outcomes will be measured for this protocol.
Primary Outcome:
1. Clinical evaluation for presence of SSI (and standard of care culture etiology, if SSI is present) at all
follow-up visits.
Secondary Outcomes:
1. Patient compliance survey: Patients will be assessed for compliance on the morning of surgery. 2.
Patient satisfaction: Patient satisfaction will be measured by asking each subject a single subjective
question at baseline and each subsequent follow-up visit. Subjects will be asked “How satisfied are
you with your orthopedic care?” Response options include: “Very Satisfied, Satisfied, Dissatisfied,
and Very Dissatisfied”.
3. Patient Pain scores: Patients will be asked to rate their pain on a 1-10 scale at each visit.
4. Patient Reported Outcome Scores (PROMIS): PROMIS scores are clinical outcome
questionnaire taken on iPad with emerging questions that change based on participant’s
response. http://www.healthmeasures.net/explore-measurement-systems/promis
5. Foot Function Index (FFI) questionnaire (attached)
6. Visual assessment of wound healing and scar formation will be performed at each post-operative


visit
7. Patients will be asked about any side effects regardless of intervention arm- the percentage of
patients who report side effects, including rashes, irritation, or allergic reactions will be
calculated for each intervention.
15. Background - in nontechnical, lay language
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the design of this protocol.
Include any relevant past or current research by the PI. For drug and device studies, summarize the previous
results (i.e., Phase I/II or III studies).
FOR 200 Revised 4/23/2020 Page 9 of 16 07/29/19
There is currently no clear consensus in the surgical community regarding the best local surgical site
treatment protocol for the prevention of surgical site infections. The most recent CDC guidelines on
antiseptic prophylaxis from 2017 recommend the following:
“8A.1 Advise patients to shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or
an antiseptic agent on at least the night before the operative day. (Category IB–strong recommendation;
accepted practice.)
8A.2 Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and
harms regarding the optimal timing of the preoperative shower or bath, the total number of soap or
antiseptic agent applications, or the use of chlorhexidine gluconate washcloths for the prevention of SSI.
(No recommendation/ unresolved issue.)” [1]
Without a clear consensus on the best standard of care in this area and with uncertainty surrounding the
efficacy and limitations of chlorhexidine gluconate (CHG), there is a need for more research in this area.
This study hopes to compare a commercially available presurgical bath wipe, TheraworxTM, to 2%
chlorhexidine gluconate and simple bathing in adult patients undergoing orthopedic surgery.
TheraworxTM is a non-rinse skin formulation that combines multiple ingredients, including Aloe
Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E,
Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver,
and Beta Glucan, in preoperative disposable bath wipes. The wipes are gamma irradiated for sterilization.
The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around
4.6. In vitro studies have shown that TheraworxTM is effective in reducing carbapenem-resistant entero
bacteriaceae and MRSA in skin analogue and plated collagen, respectively [2,3]. Another study comparing
skin cultures from 30 health patients after full body scrub by either TheraworxTM or chlorhexidine, found
that TheraworxTM had a statistically better log reduction in bacteria in 1 of 4 body areas at 2 and 6 hours,
with a trend toward reduction in the other 3 areas [4]. In a multi-center study, the use of TheraworxTM
wipes for urinary catheter insertion was found to reduce the rate of nosocomial CAUTI in ICU patients [5].
This study seeks to evaluate the in vivo efficacy of TheraworxTM for reducing surgical site infection rate in
adult orthopedic surgery patients.
[1] Berrios-Torres, et al. “Centers for Disease Control and Prevention Guideline for the Prevention of Surgical
Site Infection, 2017” JAMA Surg. 2017
[2] Huckfeldt, R. “Duration of Action of Theraworx® Against Methicillin Resistant Staphylococcus Aureus
Utilizing an Inoculated Collagen Model” St John’s Medical Research Institute, 2009.
[3] “Efficacy of a novel skin antiseptic against carbapenem-resistant Enterobacteriaceae” American Journal Of
Infection Control, 2015
[4] Huckfeldt, R. “Theraworx® v. Chlorhexidine Gluconate Bathing and Peri-operative Skin Cleansing Study” St
John’s Medical Research Institute, 2009
[5] “Theraworx® skin care formulation reduces nosocomial associated CAUTI rates when used for urinary


catheter insertion and maintenance” Journal of Clinical and Medical Investigations 2015 [6] “Patient
preoperative skin preparation evaluation of one test product, Theraworx®, and one comparator  product,
Hibiclens® 4% chlorhexidine solution (CHG)” Bioscience laboratories, Inc 2017 [7] “Forearm controlled
application test for evaluating the relative mildness and skin moisturization effectiveness  of two products”
Theraworx® and Hibiclens® 4% chlorhexidine solution (CHG), Bioscience laboratories, INC  2017
[8] “An In-vitro evaluation of one test product, Theraworx® and one comparator product Dyna-Hex2® 2%
chlorhexidine solution (CHG) for mucosal irritation using the MTT ET-50 reduction method”, Bioscience
laboratories, INC 2017
FOR 200 Revised 4/23/2020 Page 10 of 16 07/29/19
[9] “An In-vitro evaluation of one test product Theraworx® and one reference product Dyna-Hex 2® 2%
chlorhexidine solution (CHG) for its antimicrobial properties using the time-kill method”, Bioscience laboratories,
INC 2017
16. Participants (Screening and Selection)
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the number for each
site)? 500 patients
If multi-site study, total number at all sites/institutions:
b. Describe the characteristics of anticipated or planned participants (if multiple groups, repeat list for each
group).
Sex: Male or Female
Race/Ethnicity: All
Age: 18 or older
Health status: Deemed healthy enough for orthopedic surgery and without clinical signs of infection
c. From what population(s) will the participants be derived? Majority of patient participants will likely be
older adults from Birmingham, Alabama and the surrounding area. These will be patients who will
undergo
surgical
procedures
by
board
certified
orthopedic
surgeons
in
UAB
Division
of
Orthopaedics.
Describe your ability to obtain access to the proposed population that will allow recruitment of the
necessary number of participants: The participants are patients of Dr. Shah and Dr. Naranje and
employees who work with researchers. Orthopedic research fellows will recruit participants for this
study through directly talking to the patients in clinic.
d. Describe the inclusion/exclusion criteria:
Inclusion Criteria: deemed healthy enough for orthopedic surgery, age 18 and older, willing to comply
with study protocol, and without clinical signs of skin infection
Exclusion Criteria: previous allergic reaction or absolute contraindication to topical chlorhexidine
gluconate or any other study product ingredient, dermatologic disorders around the surgical site, signs
of other infections, age under 18, pregnancy
e. If participants will comprise more than one group or stratification, describe each group (e.g.,
treatment/intervention, placebo, controls, sham treatment) and provide the number of participants
anticipated in each group.


Control group – 160 patients who will receive only standard skin preparation prior to surgery.
Intervention group 1 – 160 patients who will be administered 2% Chlorhexidine Gluconate wipes once
on the night prior to surgery and once on the day of surgery in addition to standard skin preparation.
Intervention group 2 – 180 patents who will be administered TheraworxTM wipes once on the night
prior to surgery and once on the day of surgery in addition to standard skin preparation.
f. Indicate which, if any, of the special populations listed below will be involved in the protocol. Include the
Special Populations Review Form (SPRF) if indicated.
☐Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates
☐Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates
FOR 200 Revised 4/23/2020 Page 11 of 16 07/29/19
☐Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates
☐Prisoners: Attach SPRF—Prisoners
☐Minors (<18 years old): Attach SPRF—Minors NOTE: For BVAMC Research <19 years old
☒Employees or students at institution where research conducted
☐Persons who are temporarily decisionally impaired
☐Persons who are permanently decisionally impaired
☐Non-English Speakers
For each box checked, describe why the group is included and the additional protections provided to protect
the rights and welfare of these participants who are vulnerable to coercion: There’s no reason to exclude
participants who are employees or students at UAB. We will explain that the decision to participate or
not in this study will not affect the participant’s relationship with UAB and the investigators. g. List any
persons other than those directly involved in the protocol who will be at risk. If none, enter  “None”: None
h. Describe the recruitment process (e.g., medical record review, referrals, letter of invitation, existing patients)
that will be used to seek potential participants (e.g., individuals, records, specimens). Research recruitment
by non-treating physicians/staff may require completion of Partial Waiver of Authorization for
Recruitment/Screening. Dr. Shah and Dr. Naranje will screen their pre-surgical clinic patients for
potential participants though their clinic encounters and ask patients if they are interested in
participating. Orthopaedic research fellows, will provide explanations to patients and consent patients
for the study in Highlands hospital following a guideline set by Dr. Shah. Additionally, Drs. Shah and
Naranje may enroll their own patients if clinical time permits. Other orthopedic surgeons at UAB
Highlands hospital may be invited to participate in recruiting patients for this study in the future if
needed to achieve an adequate number of participants. They will be fully instructed on all recruitment
guidelines and procedures.
i. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach potential participants, attach
a copy of each item. If not, identify the source (e.g., IRB Protocol Number for approved databases) from
which you will recruit participants. Participants will be recruited from Dr. Shah’s and Dr. Naranje’s clinic
j. Describe the screening process/procedures for potential participants. Dr. Shah and Dr. Naranje will screen
their pre-surgical clinic patients for potential participants though their clinic encounters by asking if
patients are interested in participation and meet inclusion/exclusion criteria. If patient is interested and
eligible, a research fellow, research nurse, or Dr. Naranje will proceed to consent the patients.
17. Protocol Procedures, Methods, and Duration - in nontechnical, lay language
a. Describe the procedures for all aspects of your protocol. Tell us what you are doing.
This study is a randomized study that will include three groups: a control group, intervention group 1
that will be administered topical 2% chlorhexidine gluconate (CHG) wipes once the night before


surgery and once on the day of surgery, and intervention group 2 that will be administered topical
TheraworxTM wipes once the night before surgery and once on the day of surgery. After IRB is
approved, 500 participants (160-180 per group) will be collected for the prospective study. Patients will
be randomized into groups using a random number list generated in excel, which will be consulted by a
research nurse or research fellow, who will instruct the patient in the use of the product related to their
group assignment. Dr. Shah or Dr. Naranje will perform orthopedic surgery on the participants without
knowledge of their group assignment. Patients will be assessed for regimen compliance by survey. At
clinic visits, patients will be assessed for the presence of surgical site infection, wound healing and scar
formation, pain scores, and will be asked to complete a self-administered patient satisfaction
questionnaire.
FOR 200 Revised 4/23/2020 Page 12 of 16 07/29/19
b. What is the probable length of time required for the entire protocol (i.e., recruitment through data analysis to
study closure)? 2 years
c. What is the total amount of time each participant will be involved? 1 year
d. If different phases are involved, what is the duration of each phase in which the participants will be involved?
If no phases are involved, enter “None.” None
e. List the procedures, the length of time the procedure takes, the total # of times the procedure is performed,
and indicate whether each is performed solely for research or would already be performed for treatment or
diagnostic purposes (routine care) for the population.
-Insert additional table rows as needed.
-If procedure is sometimes research and sometimes routine care, include on separate lines with number of
times as each.
Procedure
Length of Time Required
of  Participants
Total # of Times the
Procedure  is Performed
Research (Res) –OR-
Routine  Care
Orthopedic
surgery
1 day
1
☐Res ☒Routine
Skin product
application
5 min
2
☒Res ☐Routine
Patient Survey
5 min
1
☒Res ☐Routine
f. Will an interview script or questionnaire be used? ☒Yes ☐No If Yes, attach a copy.
g. Will participants incur any costs as a result of their participation? ☐Yes ☒No If Yes, describe the reason
for and amount of each foreseeable cost.
h. Will participants be compensated? ☐Yes ☒No If Yes, complete i-v.
i. Type: (e.g., cash, check, gift card, merchandise):
ii. Amount or Value:
iii. Method (e.g., mail, at visit):
iv. Timing of Payments: (e.g., every visit, each month):
v. Maximum Amount of Compensation per Participant:


18. Benefits
Describe the potential benefits of the research. The research has the potential to benefit the U.S. health
care system, surgeons, and patients. In recent years, surgical site infections occur in about 2% of all
patients undergoing orthopedic procedures. Surgical site infections often necessitate longer hospital
stays, increased use of antibiotics, and even revision surgery and puts economic burden on patients,
physicians, and hospitals. This research aims to highlight the effectiveness of TheraworxTM wipes to
reduce the rate of surgical site infections and to introduce the wipes as a part of the standard skin
preparation for various orthopedic procedures.
19. Risks - in nontechnical, lay language
a. List the known risks for participants as a result of participation in the research. This should not include the
minimal risk of loss of confidentiality. However, it should include any physical, psychological, social,
economic, and/or legal risks. If there is a greater than minimal risk of loss of confidentiality describe why this
is so. Do not list risks associated with the standard-of-care procedures.
FOR 200 Revised 4/23/2020 Page 13 of 16 07/29/19
NOTE: Risks included here should be included in the consent form or information sheet, as applicable. The
major risk of this study is possible allergic or serious skin reaction to the 2% topical Chlorhexidine
Gluconate or TheraworxTM wipes. Up to 10% may experience dryness, itching, or rash on the
application site. Very rarely (less than 1% of patients), patients may experience a serious allergic
reaction within minutes after the application of the wipe.
b. Estimate the frequency, severity, and reversibility of each risk listed. N/A
c. Is this a therapeutic study or intervention? ☐Yes ☒No If Yes, complete i.-iii.
i. Describe the standard of care in the setting where the research will be conducted:
ii. Describe any other alternative treatments or interventions:
iii. Describe any withholding of, delay in, or washout period for standard of care or alternative treatment
that participants may be currently using:
d. Do you foresee that participants might need additional medical or psychological resources as a result of the
research procedures/interventions? ☐Yes ☒No If Yes, describe the provisions that have been made to
make these resources available.
e. Do the benefits or knowledge to be gained outweigh the risks to participants? ☒Yes ☐No If No, provide
justification for performing the research:
20. Precautions/Minimization of Risks
a. Describe precautions that will be taken to avoid risks and the means for monitoring to detect risks. There are
minimal risks and risk of randomization involved with this study. Even so, patients will be in the clinic
under the care of the nursing staff and the operating team. Patients will be closely monitored for any
adverse reaction due to the topical products before their surgery begins. Patients will also be informed
about the possibility of adverse reactions and instructed to discontinue use and seek immediate medical
attention if they experience any signs or symptoms of serious adverse effects or severe allergic reactions.
Patients with contraindications to any of the interventions will be excluded from the study.
If the protocol involves drugs or devices skip Items 20.b. and 20.c. and go to Item 21. Instead, include
this  information in the Drug Review Sheet or Device Review Sheet, as applicable.
b. If hazards occur to an individual participant, describe (i) the criteria that will be used to decide whether that
participant should be removed from the protocol; (ii) the procedure for removing such participants when


necessary to protect their rights and welfare; and (iii) any special procedures, precautions, or follow-up that
will be used to ensure the safety of other currently enrolled participants.
c. If hazards occur that might make the risks of participation outweigh the benefits for all participants, describe
(i) the criteria that will be used to stop or end the entire protocol and (ii) any special procedures,  precautions,
or follow-up that will be used to ensure the safety of currently enrolled participants. N/A
21. Informed Consent
a. Do you plan to obtain informed consent for this protocol? ☒Yes ☐No If Yes, complete the items below.
If No, complete and include the Waiver of Informed Consent or Waiver of Authorization and Informed
Consent, as applicable.
*For research being conducted at the BVAMC, the UAB Consent waiver form must be completed and
submitted with the HSP.
b. Do you plan to document informed consent (obtain signatures) for this protocol? ☒Yes ☐No If Yes,
complete the items below.
If No, complete the items below and include the Waiver of Informed Consent Documentation.
FOR 200 Revised 4/23/2020 Page 14 of 16 07/29/19
c. How will consent be obtained? Interview,
d. Who will conduct the consent interview? Dr. Naranje, Dr. Shah
e. Who are the persons who will provide consent, permission, and/or assent? Patients
f. What steps will be taken to minimize the possibility of coercion or undue influence? Patients will not be
financially compensated, and each patient will be asked if they are interested in participating. If they
decline, no attempts will be made to convince them to participate.
g. What language will the prospective participant and the legally authorized representative understand? English
h. What language will be used to obtain consent? English
i. If any potential participants will be, or will have been, in a stressful, painful, or drugged condition before or
during the consent process, describe the precautions proposed to overcome the effect of the condition on
the consent process. If not, enter “None.” None
j. If any protocol-specific instruments will be used in the consenting process, such as supplemental handouts,
videos, or websites, describe these here and provide a copy of each. If not, enter “None.” No supplemental
handouts or instruments will be prepared by the research staff or provided to the patients by the
research staff. Patients will be verbally instructed in the use of the products by research personnel.
Additionally, patients may at their own discretion consult any instructional materials that are included
inside or on the product packaging or made publically available by the manufacturers
k. How long will participants have between the time they are told about the protocol and the time they must
decide whether to enroll? If not 24 hours or more, describe the proposed time interval and why the 24-hour
minimum is neither feasible nor practical. >24 hours
22. Procedures to Protect Privacy
Describe how you will protect the privacy interest of the participants. Include how you will make sure others
cannot overhear your conversation with potential participants and that individuals will not be publicly identified
or embarrassed.
Individuals will not be publicly identified and all conversations pertaining to study participants will be
held in private rooms.
23. Procedures to Maintain Confidentiality


a. Describe how you will store research data to maintain confidentiality (both paper records and electronic
data), including how access is limited. If data will be stored electronically anywhere other than a server
maintained centrally by UAB, identify the department and all computer systems used to store protocol
related data.
Data will be stored in the UAB hospital server. It will be accessed from hospital computers at
Highlands. The file will only be accessible by directly involved investigators.
b. Will any data from this protocol be given to any person, including the subject, or any group, including
coordinating centers and sponsors? ☒Yes ☐No If Yes, complete i-iii.
i. Who will receive the data? Data will be used for publication but it will be
de-identified ii. What data will be shared? Study data
iii. How will the data be identified, coded, etc.? De-identified, coded with unique identifier
number 24. Genomic Data Sharing (GDS)
FOR 200 Revised 4/23/2020 Page 15 of 16 07/29/19
Researchers who collect genomic data as part of a NIH grant funded after January 25, 2008 may be required to
submit those data to a NIH database for broad scientific sharing. See Genomic Data Sharing in the IRB Guidebook
for more information.
a. Does this protocol involve the proposed submission of genetic data into genomic repositories created to share
genetic information for research purposes? ☐Yes ☒No
b. Will UAB be uploading the final genomic data to the central repository (e.g., dbGaP)? ☐Yes ☐No If Yes to
both a and b, submit a Detailed Data Sharing Plan to the IRB for review. This plan should include any known
data use limitations and indicate whether aggregate-level data are appropriate for general research use. For
guidance see the NIH Genomic Data Sharing Policy.
c. Submit a copy of the NIH Institutional Certification Form.
To determine which certification form to include, answer i-ii.
i. Was this protocol funded prior to January 25, 2015? ☐Yes ☐No ∙If yes, and consent will be obtained,
submit the Extramural Institutional Certification - Before January 25 - With Consent.
∙If yes, and consent will not be obtained, submit the Extramural Institutional Certification - Before
January 25 - Without Consent.
ii. Was this protocol funded after January 25, 2015? ☐Yes ☐No ∙If yes, submit the Extramural
Institutional Certification - After January 25.
25. Additional Information
In the space below, provide any additional information that you believe may help the IRB review the proposed
research, or enter “None.” None


FOR 200 Revised 4/23/2020 Page 16 of 16 07/29/19

SAP_001.pdf: 
 
 Statistical Analysis Plan (SAP)  
 
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic 
Surgery Patients 
 
 
 
Last Update: 2/6/22 
 
Principal Investigator  
 
 
Ashish Shah, M.D. 
Associate Professor, Director of Clinical Research 
Department of Orthopaedic Surgery 
1313 13th Street South, Suite 226 
Birmingham, AL 35205 
 
Protocol Identification Number 
 
NCT03401749 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Table of Contents: 
 
1. Introduction…………………………………………………………………………. 3 
2. Study Design………….…………………………………………………………….. 3 
3. Aims and objectives……….………………………………………………………... 3  
4. Outcomes…………………………………………………………………………… 3 
4.1 Primary Outcomes……………………………………………………………… 3 
4.2 Secondary Outcomes…………………………………………………………… 4  
5. Populations to be Analyzed………………………………………………………… 4 
6. Analyses……………………………………………………………………………. 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
1. Introduction  
The aim of this project was to assess in a single center randomized clinical trial (RCT) the 
use of the addition of 2 doses of 2% topical chlorhexidine gluconate wipes or topical 
TheraworxTM wipes to standard ChloroPrep skin preparation on patients undergoing 
orthopedic surgery procedures. Our objective is to test the hypothesis that administration of 
2% topical chlorhexidine gluconate or topical TheraworxTM wipes (one dose the night 
before surgery and one on the day of surgery) will reduce the number of surgical site 
infections in patients undergoing orthopedic surgery procedures. Furthermore, we will 
explore whether the rate of surgical site infections from patients who utilized 2% topical 
chlorhexidine gluconate wipes significantly differs from those who utilized topical 
TheraworxTM wipes.  
 
2. Study Design 
This study is a randomized study that will include three groups: a control group, intervention 
group one that will be administered topical 2% chlorhexidine gluconate (CHG) wipes once 
the night before surgery and once on the day of surgery, and intervention group two that will 
be administered topical TheraworxTM wipes once the night before surgery and once on the 
day of surgery. After IRB is approved, 500 participants (160-180 per group) will be collected 
for the prospective study. Patients will be randomized into groups using a random number 
list generated in excel, which will be consulted by a research nurse or research fellow, who 
will instruct the patient in the use of the product related to their group assignment. Dr. Shah 
or Dr. Naranje will perform orthopedic surgery on the participants without knowledge of 
their group assignment. Patients will be assessed for regimen compliance by survey. At clinic 
visits, patients will be assessed for the presence of surgical site infection, wound healing and 
scar formation, pain scores, and will be asked to complete a self-administered patient 
satisfaction questionnaire. 
 
Patients will be assessed for signs and symptoms of infection at their two-week, six-week, 
and three-month clinical visits. We will continue follow up for one year postoperatively and 
compare the infection rate among the three groups.  
 
 
3. Aims and Objectives 
To study if 2% topical chlorhexidine gluconate or topical TheraworxTM wipes night before 
will reduce the number of surgical site infections in patients undergoing orthopedic surgery 
procedures.  
 
4. Outcomes 
This section will present the outcomes investigated to answer the study aims and objectives. 
The analyses are described in section 6 Analyses. 
 
4.1 Primary Outcome 
Infection rate between the three study cohorts. Signs and symptoms of infection will be 
measured at the 2-week, 6-week, and 3-month visits. 
 


 
 
4.2 Secondary Outcomes  
o Patient compliance survey: Patients will be assessed for compliance on the morning 
of surgery. 
o Visual assessment of wound healing and scar formation will be performed at each 
post-operative visit. 
o Patients will be asked about any side effects regardless of intervention arm- the 
percentage of patients who report side effects, including rashes, irritation, or allergic 
reactions will be calculated for each intervention. 
 
5. Populations to be Analyzed 
Inclusion Criteria: deemed healthy enough for orthopedic surgery, age 18 and older, willing 
to comply with study protocol, and without clinical signs of skin infection. 
 
Exclusion Criteria: previous allergic reaction or absolute contraindication to topical 
chlorhexidine gluconate or any other study product ingredient, dermatologic disorders around 
the surgical site, signs of other infections, age under 18, pregnancy. 
 
Patients will be randomly placed into study cohort.  
 
5.1 Populations  
Control group: 160 patients who will receive only standard skin preparation prior to surgery. 
 
Intervention group 1: 160 patients who will be administered 2% Chlorhexidine Gluconate 
wipes once on the night prior to surgery and once on the day of surgery in addition to 
standard skin preparation. 
 
Intervention group 2: 180 patents who will be administered TheraworxTM wipes once on the 
night prior to surgery and once on the day of surgery in addition to standard skin preparation. 
 
Intention-to-Treat 
All randomized study subjects. This will be the primary population for analysis.  
 
Per Protocol 
All randomized study subjects completing the whole study period (complete cases). For a 
specific analysis, study subjects with missing data on any of the variables in the model 
will be excluded from the analysis. 
 
6. Analyses 
The primary analysis will compare intervention groups and their respected rate of infection 
between baseline, 2-weeks. 6-weeks, and 3 months using a linear mixed model. Difference in 
infection rate from baseline to time points where it is measured during the study will be the 
dependent variable. Study subjects will be considered as random effects, treatment group and 
visit number as fixed effects.  
 


Patient compliance was monitored via patient questionnaires on the date of surgery. If 
compliance rate differed significantly, it would be labeled as a confounding factor.