Povidone-Iodine for Nasal Decolonization

NCT05529173 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro2021000468
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Wound Infection; Preoperative Care; Methicillin-Resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen.

  The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU.

  1, 2, and 3 hours after application of Povidone-Iodine or saline solution

Secondary Outcomes (1)

• Surgical Site Infections

  at 7 and 30-day postoperative intervals

Study Arms (2)

treatment

EXPERIMENTAL

Application of Povidone-Iodine 10% prior to surgery to Nares

Drug: Povidone-Iodine 10%

placebo

PLACEBO COMPARATOR

Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares

Drug: 0.9% NaCl Solution

Interventions

Povidone-Iodine 10% DRUG

Nasal swab stick application of Povidone-Iodine 10% prior to surgery

Also known as: Profend

treatment

0.9% NaCl Solution DRUG

Nasal swab stick application of 0.9% NaCl Solution prior to surgery

Also known as: Normal Saline (NS)

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (5)

• 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.

  PMID: 19281889 BACKGROUND

• 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.

  PMID: 22944390 BACKGROUND

• 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.

  PMID: 22964685 BACKGROUND

• 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.

  PMID: 23973424 BACKGROUND

• 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.

  PMID: 29291157 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Dennis Grech
• Organization: Rutgers - NJ Medical School

grechde@njms.rutgers.edu

973 972-5007

Study Officials

• Alex Bekker, MD/PhD

  Rutgers University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients are assigned to treatment group or placebo

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 6, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 17, 2023
• Last Updated: November 13, 2024
• Results First Posted: November 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)