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OpenTrials
Completed

NCT Number: NCT05529173

Povidone-Iodine for Nasal Decolonization

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Newark, New Jersey, 07103, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povidone-Iodine 10%

Drug

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

Other names: Profend

0.9% NaCl solution

Drug

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

Other names: Normal Saline (NS)

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.

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

    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.

Secondary outcomes

  1. Surgical Site Infections

    Time frame: at 7 and 30-day postoperative intervals

    The presence of surgical site infections

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study 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 S. Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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