Trial Outcomes & Findings for Povidone-Iodine for Nasal Decolonization (NCT NCT05529173)
NCT ID: NCT05529173
Last Updated: 2024-11-13
Results Overview
The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
1, 2, and 3 hours after application of Povidone-Iodine or saline solution
Results posted on
2024-11-13
Participant Flow
Participant milestones
| Measure |
Treatment
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
97
|
|
Overall Study
COMPLETED
|
88
|
91
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Treatment
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
6
|
|
Overall Study
Sample shipment delay more than one day
|
4
|
0
|
Baseline Characteristics
Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
Baseline characteristics by cohort
| Measure |
Treatment
n=88 Nasal samples
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
n=91 Nasal samples
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
Total
n=179 Nasal samples
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=95 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=192 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=95 Participants
|
86 Participants
n=97 Participants
|
174 Participants
n=192 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=95 Participants
|
11 Participants
n=97 Participants
|
18 Participants
n=192 Participants
|
|
Age, Continuous
|
44.86 years
STANDARD_DEVIATION 14.97 • n=95 Participants
|
47.27 years
STANDARD_DEVIATION 14.84 • n=97 Participants
|
46.08 years
STANDARD_DEVIATION 14.92 • n=192 Participants
|
|
Sex/Gender, Customized
Female
|
49 Participants
n=95 Participants
|
51 Participants
n=97 Participants
|
100 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Male
|
44 Participants
n=95 Participants
|
45 Participants
n=97 Participants
|
89 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Prefer not to identify
|
0 Participants
n=95 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=192 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 Participants
n=95 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
38 Participants
n=95 Participants
|
46 Participants
n=97 Participants
|
84 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
12 Participants
n=95 Participants
|
13 Participants
n=97 Participants
|
25 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=95 Participants
|
4 Participants
n=97 Participants
|
6 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
37 Participants
n=95 Participants
|
31 Participants
n=97 Participants
|
68 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=95 Participants
|
2 Participants
n=97 Participants
|
6 Participants
n=192 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=95 Participants
|
1 Participants
n=97 Participants
|
3 Participants
n=192 Participants
|
|
Number of S. aureus/ MRSA colony-forming unit (CFU) per Sample
Number of S. aureus CFU per Sample
|
2500 CFU per sample
n=88 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
2500 CFU per sample
n=91 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
2500 CFU per sample
n=179 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
|
Number of S. aureus/ MRSA colony-forming unit (CFU) per Sample
Number of MRSA CFU per Sample
|
125.5 CFU per sample
n=88 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
25 CFU per sample
n=91 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
51.8 CFU per sample
n=179 Participants • Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons.
|
PRIMARY outcome
Timeframe: 1, 2, and 3 hours after application of Povidone-Iodine or saline solutionPopulation: Nasal samples (NS) taken from 42 participants out of 95 assigned to the treatment group, and 47 out of 97 assigned to the placebo group that tested positive for S. aureus before the intervention were analyzed at every following time point: 1, 2, and 3 hours after the intervention (AI). NS taken from 32 participants out of 95 assigned to the treatment group, and 35 out of 97 assigned to the placebo group were positive for MRSA at baseline and were analyzed for MRSA at 1,2, and 3 hours AI.
The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU.
Outcome measures
| Measure |
Treatment
n=42 nasal samples
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
n=47 nasal samples
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
|---|---|---|
|
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.
The difference in a number of S. aureus CFU between before and 1 hour after drug application
|
12062.5 CFU per sample (∆)
Interval 2007.5 to 46023.6
|
737 CFU per sample (∆)
Interval -29445.0 to 27850.0
|
|
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.
The difference in a number of S. aureus CFU between before and 2 hours after drug applicatia
|
12525 CFU per sample (∆)
Interval 815.0 to 61425.0
|
711.2 CFU per sample (∆)
Interval -24411.0 to 58400.0
|
|
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.
The difference in a number of S. aureus CFU between before and 3 hours after drug application
|
12497 CFU per sample (∆)
Interval 1045.5 to 38075.1
|
4160 CFU per sample (∆)
Interval -2481.5 to 82383.0
|
|
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.
The difference in a number of MRSA CFU between before and 1 hour after drug application
|
2904.8 CFU per sample (∆)
Interval 349.3 to 18175.0
|
360 CFU per sample (∆)
Interval -2434.1 to 3126.7
|
|
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.
The difference in a number of MRSA CFU between before and 2 hours after drug application
|
2457 CFU per sample (∆)
Interval 254.5 to 18175.0
|
412 CFU per sample (∆)
Interval -7024.1 to 4811.0
|
|
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.
The difference in a number of MRSA CFU between before and 3 hours after drug application
|
2904.8 CFU per sample (∆)
Interval 349.3 to 18175.0
|
360 CFU per sample (∆)
Interval -2434.1 to 3126.7
|
SECONDARY outcome
Timeframe: at 7 and 30-day postoperative intervalsPopulation: Row population differs from the overall as the secondary outcome was analyzed for 88 out of 95 participants assigned to the treatment group and 91 out of 97 to the placebo group.
The presence of surgical site infections
Outcome measures
| Measure |
Treatment
n=88 Participants
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
n=91 Participants
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
|---|---|---|
|
Surgical Site Infections
Confirmed surgical site infection in the first 7 days postoperatively
|
0 Participants
|
1 Participants
|
|
Surgical Site Infections
Confirmed surgical site infection up to 30±4 days postoperatively
|
1 Participants
|
6 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=95 participants at risk
Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery
|
Placebo
n=97 participants at risk
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
nasal irritation
|
1.1%
1/95 • Number of events 1 • From the time the patient signs the Informed Consent Form for 24 hours or until discharge from the hospital, whatever comes first, an average of 12 hours
|
0.00%
0/97 • From the time the patient signs the Informed Consent Form for 24 hours or until discharge from the hospital, whatever comes first, an average of 12 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place