Povidone-Iodine for Nasal Decolonization

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-11-17

Brief Summary

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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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Detailed Description

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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

Conditions

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Surgical Wound Infection Preoperative Care Methicillin-Resistant Staphylococcus Aureus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are assigned to treatment group or placebo

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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treatment

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

Group Type EXPERIMENTAL

Povidone-Iodine 10%

Intervention Type DRUG

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

placebo

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

Group Type PLACEBO_COMPARATOR

0.9% NaCl Solution

Intervention Type DRUG

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

Interventions

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Povidone-Iodine 10%

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

Intervention Type DRUG

0.9% NaCl Solution

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

Intervention Type DRUG

Other Intervention Names

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Profend Normal Saline (NS)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No