Povidone-Iodine for Nasal Decolonization

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 4

Conditions: Methicillin-Resistant Staphylococcus Aureus; Preoperative Care; Surgical Wound Infection

Treatments: Drug: Povidone-Iodine 10%; Drug: 0.9% NaCl Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05529173

Pro2021000468

Details and patient eligibility

About

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).

Full 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

Enrollment: 192 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups, including a placebo group

treatment

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine 10%

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% NaCl Solution