Povidone-Iodine for Nasal Decolonization

Last updated: October 17, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Completed

Phase

4

Condition

Staphylococcal Infections

Pressure Ulcer

Treatment

Povidone-Iodine 10%

0.9% NaCl Solution

Clinical Study ID

NCT05529173
Pro2021000468
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Povidone-Iodine 10%
Phase: 4
Study Start date:
September 06, 2022
Estimated Completion Date:
November 17, 2023

Study 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

Connect with a study center

  • University Hospital

    Newark, New Jersey 07103
    United States

    Site Not Available

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