Clinical trial NCT05529173
Conditions: Surgical Wound Infection Preoperative Care Methicillin-Resistant Staphylococcus Aureus
Sponsor: Rutgers, The State University of New Jersey
Start date: 2022-09-06; Completion date: 2023-11-17
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).

Detailed description:
This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively

Arms: arm 1: Application of Povidone-Iodine 10% prior to surgery to Nares arm 2: Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
Interventions: intervention 1: Povidone-Iodine 10% intervention 2: 0.9% NaCl Solution
Intervention descriptions: intervention 1: Nasal swab stick application of Povidone-Iodine 10% prior to surgery intervention 2: Nasal swab stick application of 0.9% NaCl Solution prior to surgery

Protocol documents:
ICF_000.pdf: 
CONSENT TO TAKE PART IN A RESEARCH STUDY: 
“A prospective single-blind placebo-controlled trial to establish the efficacy and 
tolerability of 10% Povidone-Iodine for nasal S. aureus and MRSA decolonization 
among patients undergoing same-day surgery”. 
IC Form V.5 approved 6.28.2023 
NCT05529173 
 


HRP 502a Adult Consent for Interventional Research 01.10.22
Protocol Title: Povidone-Iodine for nasal decolonization 
Protocol Version Date:  v5 05.10.23
Page 1 of 6
STUDY SUMMARY: This consent form is part of an informed consent process for a research study, 
and it will provide information that will help you decide whether you want to take part in this study. It is 
your choice whether to take part or not.
The purpose of the research is: to determine if the use of preoperative (before surgery) Povidone- 
Iodine nasal swab can help decrease MRSA bacteria colonization in the nares (nostrils) and decrease 
the rate of surgical site infections. If you take part in the research, you will be asked to provide nasal 
cultures from both nares before, during, and after the surgery and to allow us to swab the nares with 
either saline solution (salt solution) or Povidone-Iodine (medication) solution before surgery. At the Pre- 
operating room and PACU, you will be asked a few questions about the tolerability of applied 
investigational drug. Your time in the study will take from when you arrive at the preoperative area until 
you are discharged after your surgery.
Possible harms or burdens of taking part in the study may be minor discomfort from the nasal swabs 
and possible benefits of taking part may be decreased rate of surgical site infections and contributing to 
medical knowledge.
Your alternative to taking part in the research study is not to take part in it.
CONSENT TO TAKE PART IN A RESEARCH STUDY
Title of Study: A prospective single-blind placebo-controlled trial to establish the efficacy and tolerability 
of 10% Povidone-Iodine for nasal S. aureus and MRSA decolonization among patients undergoing same- 
day surgery.
Principal Investigator: Dennis Grech, MD
The information in this consent form will provide more details about the research study and what will be 
asked of you if you choose to take part in it. If you have any questions now or during the study, if you 
choose to take part, you should feel free to ask them and should expect to be given answers you 
completely understand. After your questions have been answered and you wish to take part in the 
research study, you will be asked to sign this consent form. You are not giving up any of your legal rights 
by agreeing to take part in this research or by signing this consent form.
Who is conducting this study?
Dr. Dennis Grech is the Principal Investigator of this research study. A Principal Investigator has the 
overall responsibility for the conduct of the research. However, there are often other individuals who are 
part of the research team.
Dr. Dennis Grech may be reached at (973) 972-0470 at 185 South Orange Avenue (Room E-547), 
Newark, NJ 07101.
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HRP 502a Adult Consent for Interventional Research 01.10.22
Protocol Title: Povidone-Iodine for nasal decolonization 
Protocol Version Date:  v5 05.10.23
Page 2 of 6
The Principal Investigator or another member of the study team will also be asked to sign this informed 
consent. You will be given a copy of the signed consent form to keep.
Sponsor of the Study: Rutgers, Anesthesiology Department (PDI Healthcare is funding the study)
Why is this study being done?
The purpose of this study is to determine if the use of Povidone-Iodine nasal swab before surgery can 
help decrease MRSA bacteria colonization in the nares and decrease the rate of surgical site infections.
Who may take part in this study and who may not?
Any patient presenting to University Hospital for a same day outpatient surgery may participate in this 
study as long as they meet the following inclusion criteria and do not meet the exclusion criteria.
Inclusion criteria include:

community-based English or Spanish speaking patients ages 18-80

willing and able to consent

American Society of Anesthesiology (ASA) rating of 1, 2, or 3 as determined by anesthesiologist

undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration
Exclusion criteria include:

pregnancy

allergy to povidone-iodine

infectious indication for surgery or preexisting known infection/wound

immunocompromised state

use of chemotherapy or steroids within 30 days prior to surgery

use of antimicrobial therapy within 30 days prior to surgery

surgeries where field avoidance prevents intraoperative access to the nares
Why have I been asked to take part in this study?
Your participation in this study will help in progressing our understanding of surgical site infections and in 
assessing the efficacy of a novel method of preventing them.
How long will the study take and how many subjects will take part?
The study will last 2 years, but the patient’s participation in the study lasts only until discharge from 
University Hospital Same Day Surgery after their surgery. 200 subjects will take part in this study.
What will I be asked to do if I take part in this study?
If you decide to participate, a nasal culture will be obtained from both nares. You will then receive a nasal 
swab in both nares while in the preoperative holding area. This swab may contain either saline (placebo) 
or Povidone-Iodine solution (medication). Additional nasal cultures will be taken during the surgery as well 
as in the PACU recovery area. We expect those who receive the Povidone-Iodine swabs to have a 
decreased rate of surgical site infections. At the Pre-operating room and PACU, you will be asked a few 
questions about the tolerability of applied drugs as burning/itching, pain, irritation, epistaxis, runny nose 
and others.
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HRP 502a Adult Consent for Interventional Research 01.10.22
Protocol Title: Povidone-Iodine for nasal decolonization 
Protocol Version Date:  v5 05.10.23
Page 3 of 6
Your electronic medical records will be accessed before surgery to ensure that you are eligible for the 
study, and members of the research team will gather sociodemographic (age, XXXX) and pertinent 
medical data, ensuring that any data that is collected is deidentified (removal of name, Date of birth, 
gender, address) and kept confidential. Your electronic medical records will also be accessed at 7 and 
30-day post-operative (after surgery) intervals to assess for any surgical site infections that may have 
occurred postoperatively.
What are the risks of harm or discomforts I might experience if I take part in this study?
The risks of this study are minimal except for minor discomfort from the nasal swabs. In rare cases, there 
may be some bleeding from the nares. In addition, as with any clinical trial, there is a risk of breach of 
patient confidentiality, though we do not expect this to occur.
Are there any benefits to me if I choose to take part in this study?
The benefits of taking part in this study may be decreased risk of surgical site infections. However, it is 
possible that you may not receive any direct benefit from taking part in this study. Your participation will 
contribute to medical knowledge.
What are my alternatives if I do not want to take part in this study?
There are no alternative treatments available. Your alternative is not to take part in this study.
How will I know if new information is learned that may affect whether I am willing to stay in the 
study?
During the study, you will be updated about any new information that may affect whether you are willing 
to continue taking part in the study. If new information is learned that may affect you after the study or 
your follow-up is completed, you will be contacted.
Will I receive the results of the research?
In general, we will not give you any individual results from the study. If we find something of urgent 
medical importance to you, we will inform you, although we expect that this will be a very rare occurrence.
Will there be any cost to me to take Part in this study?
There will not be any cost to you to take part in this study.
Will I be paid to take part in this study?
You will not be paid to take part in this study.
Who might benefit financially from this research?
Neither the university, the hospital, nor the investigators are expected to directly benefit financially from 
this research.
How will information about me be kept private or confidential?
All efforts will be made to keep your personal information in your research record confidential, but total 
confidentiality cannot be guaranteed. All data will be kept on encrypted and password-protected 
computers and transmitted only via secure means. The computers will be located in a secure area only 
accessible by the research team. The only identifying data that will be kept will be the medical record 
number and the date/type of procedure. The research team will only be using a separate ID number apart 
from the medical record number to identify data. These ID numbers will also ensure that subjects remain 
anonymous. The study will end after approximately 2 years and the data will be used in writing and 
publishing the manuscript, which will occur in the months following the end of the data collection period. 
The content will be published in a peer-reviewed scientific journal. Deidentified data will not be destroyed. 
The link (identifying code) to the personal identifiers will be kept for six years after study completion.
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Protocol Title: Povidone-Iodine for nasal decolonization 
Protocol Version Date:  v5 05.10.23
Page 4 of 6
The research team may use or share your information collected or created for this study with the following 
people and institutions:

The Rutgers University Institutional Review Board.

The Office for Human Research Protections in the U.S. Dept. of Health and Human Services

The scientific Community.
A description of this clinical study will be available on 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.
What will happen to my information—data, recordings and/or images—and biospecimens 
collected for this research after the study is over?
After information that could identify you has been removed, de-identified information/biospecimens 
collected for this research may be used for other research we conduct without obtaining additional 
informed consent from you.
What will happen if I am injured during this study?
Subjects in this study will be exposed to certain risks of personal injury in addition to those associated 
with standard forms of treatment, as identified above. In addition, it is possible that during the course of 
this study, new adverse effects of Povidone-Iodine nasal swabs that result in personal injury may be 
discovered. The University will make appropriate referrals for medical and/or dental treatment for subjects 
who sustain personal injuries or illnesses as a direct consequence of participation in the research. The 
subject’s health insurance carrier or other third-party payer will be billed for the cost of this treatment; 
provided that the University shall not submit to federally funded programs, e.g., Medicare, Medicaid or 
TRICARE/CHAMPUS, for reimbursement first if submission to such programs is prohibited by law. No 
financial compensation will be provided by the University and no other type of assistance is available from 
the University. However, by signing this form, you are not giving up any legal rights to seek further 
compensation.
What will happen if I do not wish to take part in the study or if I later decide not to stay in the 
study?
It is your choice whether to take part in the research. You may choose to take part, not to take part or you 
may change your mind and withdraw from the study at any time. If you do not want to enter the study or 
decide to stop taking part, your relationship with the study staff will not change, and you may do so 
without penalty and without loss of benefits to which you are otherwise entitled.
Any data that has already been collected cannot be withdrawn because there may not be any identifiers 
to link the data with you. Even if you withdraw from taking part in the study, outcome data will continue to 
be collected about you, such as medical course or lab results obtained through medical chart review.
Public records may also be consulted, such as those establishing survival status.
Who can I contact if I have questions?
If you have questions, concerns or complaints about the research, wish more information or if you feel 
you may have suffered a research related injury, you can contact the Principal Investigator: Dr. Dennis 
Grech, Anesthesiology department, (973) 972-0470.
If you have questions, concerns, problems, information or input about the research or would like to know 
your rights as a research subject, you can contact the Rutgers IRB Director at Newark Health Sciences 
IRB, 65 Bergen St., SSB 511, Newark, NJ 07107, (973)-972-3608 or the Rutgers Human Subjects 
Protection Program at (973) 972-3608 or (732) 235-9806, email us at human-
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Protocol Title: Povidone-Iodine for nasal decolonization 
Protocol Version Date:  v5 05.10.23
Page 5 of 6
subjects@research.rutgers.edu., or write us at 335 George Street, Liberty Plaza Suite 3200, New 
Brunswick, NJ 08901.
PERMISSION (AUTHORIZATION) TO USE OR SHARE HEALTH 
INFORMATION THAT IDENTIFIES YOU FOR A RESEARCH STUDY
The next few paragraphs tell you about how investigators want to use and share identifiable health 
information from your medical record in this research. Your information will only be used as described 
here or as allowed or required by law. If you sign this consent form, you agree to let the investigators use 
your identifiable health information in the research and share it with others as described below. Ask 
questions if there is something you do not understand.
What Is The Purpose Of The Research And How Will My Information Be Used?
You are being invited to take part in this research study which is described at the beginning of this form. 
The purpose of collecting and using your health information for this study is to help investigators answer 
the questions that are being asked in the research.
What Information About Me Will Be Used?

Hospital discharge summaries

Radiology records or images (MRI, CT, PET scans)

Medical history or treatment

Medications

Consultations

Laboratory/diagnostic tests or imaging

Pathology reports, specimen(s) or slide(s)

Operative reports (about a surgery)

Dental records

Emergency Medicine reports

Progress notes from outpatient follow-up visits
Who May Use, Share or Receive My Information?
The research team may use or share your information collected or created for this study with the following 
people and institutions:

Rutgers University Investigators Involved in the Study

The Rutgers University Institutional Review Board and Compliance Boards

The Office for Human Research Protections in the U.S. Dept. of Health and Human Services

Hospital Personnel as Necessary for Clinical Care: University Hospital
Those persons or organizations that receive your information may not be required by Federal privacy 
laws to protect it and may share your information with others without your permission, if permitted by the 
laws governing them.
Will I Be Able To Review My Research Record While The Research Is Ongoing?
No. We are not able to share information in the research records with you until the study is over. To ask 
for this information, please contact the Principal Investigator, the person in charge of this research study.
Do I Have To Give My Permission?
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Protocol Version Date:  v5 05.10.23
Page 6 of 6
AGREEMENT TO TAKE PART IN RESEARCH
Subject Consent:
I have read this entire consent form, or it has been read to me, and I believe that I understand what 
has been discussed. All of my questions about this form and this study have been answered. I agree 
to take part in this study.
Subject Name (Print): 
 
Subject Signature: 
Date:
 
Signature of Investigator/Individual Obtaining Consent:
To the best of my ability, I have explained and discussed all the important details about the study 
including all of the information contained in this consent form.
Investigator/Person Obtaining Consent (Print): 
 
Signature: 
Date:  
No. You do not have to permit use of your information. But, if you do not give permission, you cannot take 
part in this study. (Saying no does not stop you from getting medical care or other benefits you are 
eligible for outside of this study.)
If I Say Yes Now, Can I Change My Mind and Take Away My Permission Later?
Yes. You may change your mind and not allow the continued use of your information (and to stop taking 
part in the study) at any time. If you take away permission, your information will no longer be used or 
shared in the study, but we will not be able to take back information that has already been used or shared 
with others. If you say yes now but change your mind later for use of your information in the research, you 
must write to the researcher and tell him or her of your decision: Dr. Dennis Grech at 185 South Orange 
Avenue (Room E-547), Newark, NJ 07101
How Long Will My Permission Last?
Your permission for the use and sharing of your health information will last until the end of the research 
study.
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Prot_SAP_002.pdf: 
Protocol 
“A prospective single-blind placebo-controlled trial to establish the efficacy and 
tolerability of 10% Povidone-Iodine for nasal S. aureus and MRSA decolonization 
among patients undergoing same-day surgery”. 
 
Protocol v.5 approved 09.06.2023  
NCT05529173 
 


Protocol Title: Povidone-Iodine for nasal decolonization
Protocol Version Date:  v5 05.10.23
Page 1 of 12
INTERVENTIONAL 
RESEARCH PROTOCOL TEMPLATE 
(HRP-503a) 
 
 
 
 
STUDY INFORMATION 
 

Title of Project: 
A prospective single placebo-controlled trial to establish the efficacy and tolerability of 
10% Povidone-Iodine for nasal S. aureus and MRSA decolonization among patients 
undergoing same-day surgery 
 

Principal Investigator Name 
Dennis Grech, M.D., ACHE 
 

Principal Investigator Div. & Dept. 
Department of Anesthesia and Perioperative Medicine  
Associate Professor of Anesthesiology 
Anesthesiology Service, University Hospital 
 

Principal Investigator Contact Info:  
Dennis G. Grech, M.D., ACHE.  
Rutgers New Jersey Medical School 
185 South Orange Ave, Suite MSB 538-b, Newark, NJ  07103 
973-972-5007 
grechde@njms.rutgers.edu 
 

Protocol Version and Date: 
            v5 05.10.23 
 
 
 
 
 
 
 
Table of Contents 
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Protocol Title: Povidone-Iodine for nasal decolonization
Protocol Version Date:  v5 05.10.23
Page 2 of 12
 
1.0 
Research Design 
 
 
1.1 
Purpose/Specific Aims 
 
 
1.2 
Research Significance 
 
 
1.3 
Research Design and Methods 
 
 
1.4 
Preliminary Data 
 
 
1.5 
Sample Size Justification 
 
 
1.6 
Study Variables 
 
 
1.7 
Drugs/Devices/Biologics 
 
 
1.8 
Specimen Collection 
 
 
1.9 
Data Collection 
 
 
1.10 Timetable/Schedule of Events 
 
 
2.0 
Project Management 
 
 
2.1 
Research Staff and Qualifications 
 
 
2.2 
Research Staff Training 
 
 
2.3 
Other Resources 
 
 
2.4 
Research Sites 
 
 
3.0 
Multi-Center Research 
 
 
4.0 
Subject Considerations 
 
 
4.1 
Subject Selection and Enrollment Considerations 
 
 
4.2 
Obtaining Identifiable Information About Non-Subjects 
 
 
4.3 
Number of Subjects 
 
 
4.4 
Consent Procedures 
 
 
4.5 
Special Consent Populations 
 
 
4.6 
Economic Burden and/or Compensation For Subjects 
 
 
4.7 
Risks of Harm/Potential for Benefits to Subjects 
 
 
5.0 
Special Considerations 
 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
 
5.3 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
5.4 
General Data Protection Regulation (GDPR) 
 
 
5.5 
NJ Access to Medical Research Act (Surrogate Consent)  
 
 
6.0 
Data Management Plan 
 
 
6.1 
Data Analysis 
 
 
6.2 
Data Security 
 
 
6.3 
Data Safety And Monitoring 
 
 
6.4 
Reporting Results 
 
 
6.5 
Secondary Use of Data 
 
 
7.0 
Research Repositories – Specimens and/or Data 
 
 
8.0 
Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
 
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Protocol Title: Povidone-Iodine for nasal decolonization
Protocol Version Date:  v5 05.10.23
Page 3 of 12
1.0 Research Design 
 
1.1 Purpose/Specific Aims 
To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of S. 
aureus and MRSA. 
 
A.  Objectives  
To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) 
application is effective in reducing nasal carriage of S. aureus and MRSA. 
B.  Hypotheses / Research Question(s) 
We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures 
taken perioperatively after intervention in patients who received pretreatment with PI as compared 
to patients who received sterile saline. 
 
1.2 Research Significance 
 According to some estimates, as many as 25%-30% of healthy individuals in the community have nares 
colonized with S. aureus, while 1%-2.6% have MRSA-colonized nares[1]. This nasal carriage of S. aureus 
and MRSA is a known risk factor for post-operative wound infections in several different types of 
surgery[2]. Many, if not most infections due to S. aureus occur in colonized persons[1]. In implant-based 
breast reconstruction surgeries for instance, nasal carriers of S. aureus are 3 to 6 times more likely than 
noncarriers to develop nosocomial infections with this pathogen[3]. Similarly, studies have revealed that 
MRSA nasal colonization may be an independent risk factor for surgical site infection[4]. In a particular 
study, the MRSA PCR-positive group had a 9-fold increased risk of MRSA surgical site infection 
compared to the MRSA PCR-negative group, though the former had a low incidence at 1.86%[4]. 
Coagulase-negative staphylococci (CoNS) are also important etiological agents of post-operative 
infection[5, 6]. Together, S. aureus and CoNS (predominantly S. epidermidis, a common denizen of 
human skin that can colonize nares as well) account for 50-60% of prosthetic joint infections in roughly 
equal proportions[5, 6].
The agent typically used in assessing the effectiveness of nasal decolonization is mupirocin, which has 
been shown in some studies to eradicate colonization in up to 92% of post-operative nasal cultures[7]. 
Randomized controlled trials comparing nasal mupirocin with placebo in general, gynecologic, neurologic, 
orthopedic, and cardiothoracic procedures have demonstrated that mupirocin reduces the rate of surgical-
site infection among known carriers of S. aureus[2]. In fact, the American Society of Health-System 
Pharmacists recommends screening and nasal mupirocin decolonization for S. aureus-colonized patients 
before total joint replacement and cardiac procedures[8]. Likewise, some studies indicate that nasal 
mupirocin can decolonize CoNS, with only 1.3% of CoNS isolated from the nares of orthopedic surgery 
patients and 1.6% of samples from prosthetic joint infections displaying some resistance to mupirocin[5].
The mupirocin protocol for nasal decolonization discussed in the literature entails nasal application of 
mupirocin twice a day for 5 days before surgery[7]. Our end goal is to determine whether a more 
convenient, single-dose, pre-operative 10% povidone-iodine (PI) application can offer similar if not better 
surgical site infection results as mupirocin. The first step towards this goal is to evaluate the efficacy and 
tolerability of 10% povidone-iodine in eliminating nasal carriage of S. aureus and MRSA.
 
1.3 Research Design and Methods 
Implement povidone-iodine (10%) pre-operative nasal decolonization for patients undergoing same-day 
surgery and evaluate efficacy and tolerability of this intervention in eradicating nasal colonization.  
 
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Protocol Title: Povidone-Iodine for nasal decolonization
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Page 4 of 12
A.
Research Procedures 
This will be a prospective single-blinded randomized placebo-controlled trial of two applications of 
a nasal 10% PI solution used on the intranasal mucosal surfaces of each nostril in the preoperative 
holding area within 2 hours prior to surgical incision compared with sterile saline using the same 
technique. Both the PI and sterile saline will be applied by rotating the swab over the intranasal 
mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new 
swab for each of the 4 applications.  200 subjects will be chosen from a pool of patients arriving at 
University Hospital, Newark, NJ for outpatient surgery. Inclusion criteria include community-based 
patients ages 18-80, ASA 1-3 who will be undergoing an outpatient surgery scheduled for at least 
1 hour and up to 6 hours duration. Exclusion criteria include pregnancy, allergy to povidone-iodine, 
infectious indication for surgery or preexisting known infection/wound, known immunocompromised 
state, use of antibiotics, chemotherapy, or steroids within 1 month prior to surgery. Additionally, 
patients presenting for surgeries where field avoidance prevents intraoperative access to the nares 
(e.g., ENT/OMFS/ophthalmology procedures) will be excluded. Patients will be randomly divided 
into two groups: control (sterile saline) vs. experimental (PI) This will be done via simple 
randomization using a computer program that assigns patients as they present into either the 
control or experimental group while maintaining an overall approximately even ratio of subjects in 
each group. 
B.
Data Points 
Potential subjects will be identified from surgical schedule. Patients will be asked for informed 
consent in the same-day surgery (SDS) unit. They will be given sufficient time to read the IC 
document and ask questions. While in the preoperative holding area, patients will be asked to sit 
upright at a 45-90° angle to prevent drainage into the nasopharynx. All patients will first be swabbed 
for a nasal swab specimen, once in each nostril. Patients will then receive the appropriate nasal 
applications depending on the group into which they were sorted: Povidone-Iodine or saline. The 
tolerability assessment of investigating drug will be done with every subject at the Pre-operating 
room and PACU by a few criteria as burning/itching, pain, irritation, epistaxis, runny nose, and 
others.  Nasal swab specimen will be obtained by the anesthesiologist intraoperatively 1, 2 and 3 
hours after investigational drug application as studies have shown that there a significant decrease 
in colony-forming units of MRSA even within 1-hour post-treatment [9, 10]. These cultures may be 
intraoperative or postoperative depending on the length of surgery. There will also be a nasal swab 
specimen obtained while the patient is in the PACU.  Study subjects will be stratified according to 
age, sex, comorbidities, and ethnicity. Additionally, the type of surgery, duration of surgery (Incision 
start to incision close), number of surgeons present during the procedure (Include all individuals 
scrubbed in), postoperative hospital stay length, and intraoperative time (patient in OR to patient 
out OR) will be used in data analysis. The purpose is to identify variables that increase the 
incidence of surgical site infection.
C.
Study Duration 
The study will take approximately 2 years, but chart review may continue up to 4 months after the 
last patient in the study has their procedure. Chart review of subject’s postoperative surgical clinic 
visits will be performed up to 30 days to monitor for any surgical site infection. 
D.
Endpoints 
The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in 
nasal swab specimen taken perioperatively after intervention in patients who presented with a 
positive pre-interventional nasal swab specimen. A secondary endpoint is the presence or absence 
of surgical site infections at 7 and up to 30-day postop intervals (per retrospective chart 
review). The review includes an assessment of post-operative infections, complications, and 
prescribing antibiotics (name, dose, number of days, completing).
 
1.4 Preliminary Data 
N/A 
 
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Protocol Title: Povidone-Iodine for nasal decolonization
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1.5 Sample Size Justification 
We assumed that S. aureus/MRSA suppression in 20% of patients would be clinically relevant and that 
up to 5% of patients may have suppression even without treatment. Using a one-sided alpha of 0.05 
and a beta of 80%, we calculated that we would need at least 85 patients in each group for a total of at 
least 170 patients. A paired t-test will be used to compare preintervention nasal culture CFUs to 1- hour 
post application, 2- hour post application, and 3-hour post application, nasal culture CFUs. A 2-sample 
t test will be used to compare the difference in pre- and post- intervention CFUs between the control 
and experimental groups at any endpoint. Additionally, mixed regression analysis will be used to 
determine the effect of the intervention on the CFU counts over all follow-up time points. 
 
1.6 Study Variables 
 
A.   Independent Variables, Interventions, or Predictor Variables  
Independent variable will be whether the patient received a nasal swab with Povidone-Iodine or 
sterile saline.
B.  Dependent Variables or Outcome Measures  
The decrease in CFUs in multiple time spans after intervention.
 
1.7 Drugs/Devices/Biologics  
 A. Schedule and Administration 
Povidone-Iodine 10% solution will be given intranasally as a swab with two swabs/nostril for patients in 
the experimental arm of the study. The control arm will be given sterile saline via the same method.
  
B.
Drug/Device Accountability and Storage Methods 
The study drugs will be dispensed by the pharmacy. The study drugs will be administered by study 
investigators.
 
1.8 Specimen Collection 
 
A.
Primary Specimen Collection 

Types of Specimens: 4 sets of nasal mucosal samples per subject to be collected 
by a investigator   at preoperative, intraoperative, and postoperative intervals.
 A study participant number will be associated with each sample. 

Transport: All cultures will be sent to an outside lab for testing per the following 
protocol. All swabs will be placed in a 15 mL conical screw-top tubes containing sterile 
Phosphate Buffered Saline (PBS) solution. The samples will then be shipped the same day 
by 3 PM in a foam-insulated cooler with ice packs via overnight delivery to the testing 
facility. 

Processing: Swabs will be analyzed and enumerated by an outside testing facility 
for the presence of S. aureus, MRSA, and S. epidermidis.  

Storage: The specimens will be stored in the cooler described above and will be 
shipped out to the lab that same day. Prior to shipping, they will only be accessed by the 
study team.

Disposition: Samples will be discarded after the lab has analyzed them.  
 
B.
Secondary Specimen Collection 

N/A 
 
1.9 Data Collection 
 
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A.
Primary Data Collection 

Location: Data collection will occur in the preoperative holding area, operating 
rooms, and post-anesthesia care unit of the University Hospital, Newark, NJ.  

Process of Data Collection: The investigator who is applying the saline or 10% 
PI to the study subjects will not be blinded.  Nasal cultures will be obtained by the study 
team members. Dr. Dennis Grech will be overseeing the entire study.  

Timing and Frequency: There will be swab collections prior to the procedure, at 
the one-, two-, and three-hour marks after saline or 10% PI is administered. 

Procedures for Audio/Visual Recording: N/A 

Study Instruments: n/a

Ethnographic Studies, Interviews, Or Observation: N/A 

Subject Identifiers: MRN only 
 
B.
Secondary Data Collection  

N/A 
 
 
1.10 Timetable/Schedule of Events 
 
Figure 1 Timeline of study protocol 
                      Preoperative Holding Area                                    Intraoperative         Intra- or Post Op       Postoperative        
Patient 
presents to 
UH SDS unit  
for 
outpatient 
surgery
0-hour 
nasal 
calture
Nasal 
aplication 
of either 
povidone-
iodine or 
sterile 
saline
1-hour 
nasal 
calture
2-hour 
nasal 
calture
3-hour 
nasal 
calture
 The study will last approximately 2 years from the beginning.
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
Dr. Dennis Grech will be available all days of the study. Having worked in this hospital for many years, he 
is very knowledgeable about the study site, the culture, and the patient population. He will be enlisting the 
help of study assistants to aid in the collection of data and application of the nasal swabs but will be 
directly overseeing all of this to ensure everything is in order.
 
2.2 Research Staff Training 
All involved study team members will be trained how to perform data collection and nasal swab 
application correctly.
 
2.3 Other Resources  
N/a
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2.4 Research Sites 
Rutgers – New Jersey Medical School; University Hospital, Newark, NJ.
  
3.0 Multi-Center Research 
N/A 
 
4.0 Subject Considerations 
 
4.1 Subject Selection and Enrollment Considerations  
 
A.
Method to Identify Potential Subjects 
Subjects will be chosen from a pool of patients arriving at University Hospital, Newark, NJ for 
outpatient surgery.
B.
Recruitment Details 
Subjects meeting the inclusion criteria will be identified by the anesthesiologist preoperatively and 
be given information about the study and what their participation entails. They will also be given a 
recruitment flyer with information and will have the opportunity to ask any questions they may 
have.  
C.
Subject Screening 

Inclusion Criteria 

community-based English or Spanish speaking patients ages 18-80

willing and able to consent

American Society of Anesthesiology (ASA) 1-3

undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration

      Exclusion Criteria:

pregnancy

allergy to povidone-iodine

infectious indication for surgery or preexisting known infection/wound

immunocompromised state

use of chemotherapy or steroids within 30 days prior to surgery

use of antimicrobial therapy within 30 days prior to surgery

surgeries where field avoidance prevents intraoperative access to the nares
D.
        Privacy Protections 
No information about the patients will be revealed to anyone except the study team and providers 
involved in the care of the patients.
  
4.2 Obtaining Identifiable Information About Non-Subjects 
N/A 
 
4.3 Number of Subjects 
 
A. Total Number of Subjects 
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Using a one-sided alpha of 0.05 and a beta of 80%, we calculated that we would need at least 85 
patients in each group for a total of at least 170 patients. 
B. Total Number of Subjects If Multicenter Study 
N/A 
C. Feasibility 
Based on the volume of same-day surgical procedures at University Hospital, Newark, NJ and the 
wide inclusion criteria for this study, having 170 total patients for the study should be feasible.  
 
4.4 Consent Procedures 
 
 A. Consent Process 

Location of Consent Process 
In the SDS unit of University Hospital.

Ongoing Consent 
N/A

Individual Roles for Researchers Involved in Consent 
The study team members will be obtaining the nasal swabs and will be informing the patient 
of the study and obtaining consent. 

Consent Discussion Duration 
Enough time will be spent discussing the study with the patient until all patient’s questions 
and concerns have been addressed. 

Coercion or Undue Influence 
Patients will be told that they are not obligated to participate in the study and that their care 
will not be affected by their decision.

Subject Understanding 
Key questions will be asked of the patient during the discussion to verify the patient’s 
understanding of the study and their role within it.

Protecting Privacy 
Only the patient and patient’s guest in the SDS unit will be present during the discussion.
B.
Waiver or Alteration of Consent Process  

Waiver or Alteration Details 
N/A 

Destruction of Identifiers 
N/A 

Use of Deception/Concealment 
N/A 
  
C.
 Documentation of Consent 

Documenting Consent 
Individuals will be asked to sign the consent document.   

Waiver of Documentation of Consent (i.e., will not obtain subject’s signature) 
N/A
4.5 Special Consent Populations 
 
A.
Enrolling Minors-Subjects Who Are Not Yet Adults  

Parental Permission 
N/A 

Non-Parental Permission 
N/A 

Assent Process 
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N/A 

Documentation of Assent 
N/A  

Reaching Age of Majority During Study 
N/A 
 
B.
Enrolling Wards of the State
N/A

Research Outside of NJ Involving Minors 
N/A 
 
C.
Enrolling Non-English-Speaking Subjects 
Spanish speakers will be enrolled. The Spanish version of the Informed Consent Form will be 
provided for Spanish speakers. Process for Non-English-Speaking Subjects. 
The study team will use the Language Line Translator service the University Hospital provides for 
Spanish-speaking study participants.

Short Form Consent for Non-English Speakers 
N/A
 
D.
Enrolling Adults Lacking Decision-Making Capacity (Surrogate Consent) 
N/A

Assessing Adult Capacity to Consent 
N/A

Selecting a Surrogate & Consent Process 
N/A

Subject Assent 
N/A

Selecting a Witness to the Surrogate Consent Process  
N/A

Removing a Subject 
Any patient who wishes to be removed from the study will be removed immediately. Completion 
of the study regimen is defined as 2 applications of sterile saline or PI preoperatively and at least 
one intraoperative culture obtained perioperatively after surgical incision. 
 
E.
Special Consent Considerations 
N/A
 
4.6 Economic Burden and/or Compensation for Subjects 
 
A.
 Expenses  
N/A 
B.
Compensation/Incentives 
N/A 
C.
 Compensation Documentation 
N/A 
. 
4.7 Risks of Harm/Potential for Benefits to Subjects 
 
A.
Description of Risks of Harm to Subjects 

Reasonably Foreseeable Risks of Harm 
Minimal risk of harm given only intervention is nasal swabs.
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
Risk of Harm from an Intervention on a Subject with an Existing Condition 
N/A 

Other Foreseeable Risks of Harm 
N/A 

Observation and Sensitive Information 
N/A 
B.
Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects 
N/A 
C.
Risks of Harm to Non-Subjects 
N/A 
D.
Assessment of Social Behavior Considerations 
N/A. 
E.
Minimizing Risks of Harm 
Care will be taken by the investigators to minimize any potential discomfort patients may feel from 
the nasal swabs. Electronic study subject data (demographic data, weight, height, medical 
history, diagnosis, surgery type, co-morbidities, concomitant medications, anesthesia/surgical 
record, surgical visit notes) will be obtained from the subjects’ electronic medical record and 
stored on an excel file that is maintained on a password protected hard drive in a locked room in 
MSB E-546.

Certificate of Confidentiality 
N/A

Provisions to Protect the Privacy Interests of Subjects 
N/A 
F.
Potential Direct Benefits to Subjects 
Patients in the experimental group may have a decreased risk of surgical site infection post-
operatively. 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
N/A 
5.2 Family Educational Rights and Privacy Act (FERPA) 
N/A 
 5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
N/A
5.4 General Data Protection Regulation (GDPR) 
N/A 
  
5.5 NJ Access to Medical Research Act (Surrogate Consent) 
N/A
6.0 Data Management Plan 
 
6.1 Data Analysis 
We expect a statistically significant decrease in S. aureus/MRSA colonization in cultures taken 
perioperatively after intervention in patients who received pretreatment with PI as compared to patients 
who received sterile saline. We assumed that S. aureus/MRSA suppression in 20% of patients would 
be clinically relevant and that up to 5% of patients may have suppression even without treatment. Using 
a one-sided alpha of 0.05 and a beta of 80%, we calculated that we would need at least 85 patients in 
each group for a total of at least 170 patients. A paired t-test will be used to compare preintervention 
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nasal culture CFUs to 1- hour postintervention, 2- hour postintervention, and 3-hour postintervention 
nasal culture CFUs. A 2-sample t test will be used to compare the difference in pre- and post- 
intervention CFUs between the control and experimental groups at any endpoint. Additionally, mixed 
regression analysis will be used to determine the effect of the intervention on the CFU counts over all 
follow-up time points. 
 
The data will be stratified by type of surgery, duration of surgery, and number of surgeons present 
throughout the procedure.  Additionally, the variables age, sex, race, comorbidities, postoperative 
hospital stay length, and intraoperative time will be used in data analysis. In addition, postoperative 
surgical site infection (SSI) surveillance for the study participants will be conducted at 7 and 30-
day postop intervals. 
 
An intent to treat analysis will include those who are enrolled in the study and meet eligibility 
requirements for the study. A per protocol analysis will include all eligible patients who complete the 
assigned study regimen. Completion of the study regimen is defined as 2 applications of sterile saline 
or PI preoperatively and at least two cultures obtained perioperatively. 
 
 6.2 Data Security 
Clinical data for participants will be stored in REDCap. REDCap is a secure, web-based application. 
The server is located at Rutgers University and data is stored on secure networks behind a managed 
firewall. Data abstractors and clinical investigators will be the only ones who access to identified 
dataset. Other study members will only have access to data in aggregate or de-identified datasets.
Signed IC will be kept inside the locked cabinet
 
6.3 Data and Safety Monitoring 
[This section is required when research poses greater than minimal risk of harm to subjects.] 
 
A.
Data/Safety Monitoring Plan 
N/A
 
B.
Data/Safety Monitoring Board Details 
N/A
6.4 Reporting Results 
 
A.
Individual Subjects’ Results  
Chart review of the electronic medical record will be used to follow up on patients’ visits with their 
surgeons to determine presence or absence of surgical site infections at 7 and 30-day post-
operative intervals. 
B.
Aggregate Results 
Research results will not be shared with patients personally.
 
C.
Professional Reporting 
Results from the study will be written into a manuscript for submission into an academic 
journal and possibly presented at an appropriate medical conference to share results with the 
scientific community. 
D.
Clinical Trials Registration, Results Reporting and Consent Posting
 A description of this clinical study will be available on ClinicalTrials.gov, as required by U.S. law.
6.5 Secondary Use of the Data    
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N/A  
  
7.0 Research Repositories – Specimens and/or Data 
 
  N/A
8.0 Approvals/Authorizations 
 
 Uploaded
 
9.0 Bibliography 
 
1.
Kirby, J.P. and J.E. Mazuski, Prevention of surgical site infection. Surg Clin North 
Am, 2009. 89(2): p. 365-89, viii. 
2.
Davis, G.B., et al., Identifying risk factors for surgical site infections in 
mastectomy patients using the National Surgical Quality Improvement Program 
database. Am J Surg, 2013. 205(2): p. 194-9. 
3.
Craft, R.O., B. Damjanovic, and A.S. Colwell, Evidence-based protocol for 
infection control in immediate implant-based breast reconstruction. Ann Plast Surg, 
2012. 69(4): p. 446-50. 
4.
Kalra, L., et al., Risk of methicillin-resistant Staphylococcus aureus surgical site 
infection in patients with nasal MRSA colonization. Am J Infect Control, 2013. 41(12): p. 
1253-7. 
5.
Salih, L., et al., Staphylococcus epidermidis isolates from nares and prosthetic 
joint infections are mupirocin susceptible. J Bone Jt Infect, 2018. 3(1): p. 1-4. 
6.
Tande, A.J. and R. Patel, Prosthetic joint infection. Clin Microbiol Rev, 
2014. 27(2): p. 302-45. 
7.
Septimus, E.J. and M.L. Schweizer, Decolonization in Prevention of Health Care-
Associated Infections. Clin Microbiol Rev, 2016. 29(2): p. 201-22. 
8.
Ban, K.A., et al., American College of Surgeons and Surgical Infection Society: 
Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg, 2017. 224(1): p. 59-74. 
9.
Anderson, M.J., et al., Efficacy of skin and nasal povidone-iodine preparation 
against mupirocin-resistant methicillin-resistant Staphylococcus aureus and S. aureus 
within the anterior nares. Antimicrob Agents Chemother, 2015. 59(5): p. 2765-73. 
10.
Ghaddara, H.A., et al., Efficacy of a povidone iodine preparation in reducing 
nasal methicillin-resistant Staphylococcus aureus in colonized patients. Am J Infect 
Control, 2020. 48(4): p. 456-459. 
 
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