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Clinical Trial Summary

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).


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05529173
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Completed
Phase Phase 4
Start date September 6, 2022
Completion date November 17, 2023

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