Povidone-Iodine for Nasal Decolonization

Rutgers, The State University of New Jersey192 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

192

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Surgical Site Infections

The presence of surgical site infections

Time frame: at 7 and 30-day postoperative intervals