Phase 4
N=192
Povidone-Iodine for Nasal Decolonization
Surgical Wound Infection · Preoperative Care · Methicillin-Resistant Staphylococcus Aureus
Bottom Line
View on ClinicalTrials.gov: NCT05529173 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: 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. — 12062.5; 737; 12525; 711.2 CFU per sample (∆) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Povidone-Iodine 10% (Drug); 0.9% NaCl Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
12062.5; 737; 12525; 711.2; 12497; 4160 | <0.05 sig |
| SECONDARY Surgical Site Infections |
0; 1; 1; 6 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05529173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.