Povidone-Iodine for Nasal Decolonization

Study Overview
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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).

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

Official Title
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A Prospective Single-blind Placebo-controlled Trial to Establish the Efficacy and Tolerability of 10% Povidone-Iodine for Nasal S. Aureus and Methicillin Resistant Staphylococcus Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery

Conditions
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Surgical Wound Infection, Preoperative Care, Methicillin-Resistant Staphylococcus Aureus

Intervention / Treatment
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* Drug: Povidone-Iodine 10%
* Drug: 0.9% NaCl Solution


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are assigned to treatment group or placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Application of Povidone-Iodine 10% prior to surgery to Nares | Drug: Povidone-Iodine 10%<br>* Nasal swab stick application of Povidone-Iodine 10% prior to surgery<br>* Other names: Profend;|
| Placebo Comparator: placebo<br>Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares | Drug: 0.9% NaCl Solution<br>* Nasal swab stick application of 0.9% NaCl Solution prior to surgery<br>* Other names: Normal Saline (NS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total CFU (colony forming units) | Enumeration of nasal swab samples | Perioperative Course 5 hour maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection | Presence of wound infection | Up to 30 days |