CompletedPhase 4

Povidone-Iodine for Nasal Decolonization

United States192 participantsStarted 2022-09-06

Plain-language 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).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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

Trial details

NCT IDNCT05529173

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-13

Results submitted2024-08-28

View on ClinicalTrials.gov More Surgical Wound Infection trials