Povidone-Iodine for Nasal Decolonization
Primary Purpose
Surgical Wound Infection, Preoperative Care, Methicillin-Resistant Staphylococcus Aureus
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Povidone-Iodine 10%
0.9% NaCl Solution
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection
Eligibility Criteria
Inclusion Criteria:
- community-based patients ages 18-80
- 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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment
placebo
Arm Description
Application of Povidone-Iodine 10% prior to surgery to Nares
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
Outcomes
Primary Outcome Measures
Total CFU (colony forming units)
Enumeration of nasal swab samples
Secondary Outcome Measures
Wound infection
Presence of wound infection
Full Information
NCT ID
NCT05529173
First Posted
September 1, 2022
Last Updated
November 9, 2022
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05529173
Brief Title
Povidone-Iodine for Nasal Decolonization
Official Title
A Prospective Single-blind Placebo-controlled Trial to Establish the Efficacy and Tolerability of 10% Povidone-Iodine for Nasal S. Aureus and Methicillin Resistant Staphylococcus Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Preoperative Care, Methicillin-Resistant Staphylococcus Aureus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned to treatment group or placebo
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
Application of Povidone-Iodine 10% prior to surgery to Nares
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine 10%
Other Intervention Name(s)
Profend
Intervention Description
Nasal swab stick application of Povidone-Iodine 10% prior to surgery
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl Solution
Other Intervention Name(s)
Normal Saline (NS)
Intervention Description
Nasal swab stick application of 0.9% NaCl Solution prior to surgery
Primary Outcome Measure Information:
Title
Total CFU (colony forming units)
Description
Enumeration of nasal swab samples
Time Frame
Perioperative Course 5 hour maximum
Secondary Outcome Measure Information:
Title
Wound infection
Description
Presence of wound infection
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
community-based patients ages 18-80
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Grech, MD
Phone
973-972-5007
Email
grechde@njms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Berezina, MD/PhD
Phone
9739727477
Email
bereztl@njms.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Bekker, MD/PhD
Organizational Affiliation
Rutgers University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arleen Wallen, MS, RD, MBA
Phone
973-972-7909
Email
wallenar@uhnj.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19281889
Citation
Kirby JP, Mazuski JE. Prevention of surgical site infection. Surg Clin North Am. 2009 Apr;89(2):365-89, viii. doi: 10.1016/j.suc.2009.01.001.
Results Reference
background
PubMed Identifier
22944390
Citation
Davis GB, Peric M, Chan LS, Wong AK, Sener SF. Identifying risk factors for surgical site infections in mastectomy patients using the National Surgical Quality Improvement Program database. Am J Surg. 2013 Feb;205(2):194-9. doi: 10.1016/j.amjsurg.2012.05.007. Epub 2012 Aug 31.
Results Reference
background
PubMed Identifier
22964685
Citation
Craft RO, Damjanovic B, Colwell AS. Evidence-based protocol for infection control in immediate implant-based breast reconstruction. Ann Plast Surg. 2012 Oct;69(4):446-50. doi: 10.1097/SAP.0b013e31824a215a.
Results Reference
background
PubMed Identifier
23973424
Citation
Kalra L, Camacho F, Whitener CJ, Du P, Miller M, Zalonis C, Julian KG. Risk of methicillin-resistant Staphylococcus aureus surgical site infection in patients with nasal MRSA colonization. Am J Infect Control. 2013 Dec;41(12):1253-7. doi: 10.1016/j.ajic.2013.05.021. Epub 2013 Aug 21.
Results Reference
background
PubMed Identifier
29291157
Citation
Salih L, Tevell S, Mansson E, Nilsdotter-Augustinsson A, Hellmark B, Soderquist B. Staphylococcus epidermidis isolates from nares and prosthetic joint infections are mupirocin susceptible. J Bone Jt Infect. 2018 Jan 1;3(1):1-4. doi: 10.7150/jbji.22459. eCollection 2018.
Results Reference
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Povidone-Iodine for Nasal Decolonization
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