Trial Outcomes & Findings for Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin (NCT NCT01313182)
NCT ID: NCT01313182
Last Updated: 2024-12-02
Results Overview
Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1874 participants
Primary outcome timeframe
12 months
Results posted on
2024-12-02
Participant Flow
Only patients receiving surgery were considered Started.
Participant milestones
| Measure |
3M Skin and Nasal Antiseptic
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
|---|---|---|
|
Overall Study
STARTED
|
842
|
855
|
|
Overall Study
COMPLETED
|
776
|
763
|
|
Overall Study
NOT COMPLETED
|
66
|
92
|
Reasons for withdrawal
| Measure |
3M Skin and Nasal Antiseptic
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
66
|
92
|
Baseline Characteristics
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Baseline characteristics by cohort
| Measure |
3M Skin and Nasal Antiseptic
n=842 Participants
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
n=855 Participants
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
Total
n=1697 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
n=5 Participants
|
62.4 years
n=7 Participants
|
62.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
499 Participants
n=5 Participants
|
523 Participants
n=7 Participants
|
1022 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
343 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
842 participants
n=5 Participants
|
855 participants
n=7 Participants
|
1697 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMeasure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.
Outcome measures
| Measure |
3M Skin and Nasal Antiseptic
n=776 Participants
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
n=763 Participants
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
|---|---|---|
|
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Post-surgeryPopulation: Data was not collected for this assessment.
The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Isolates collected and frozen immediately post-surgery.Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.
Outcome measures
| Measure |
3M Skin and Nasal Antiseptic
n=842 Participants
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
n=855 Participants
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
|---|---|---|
|
Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was not collected for this assessment.
Re-admission rates in the Mupirocin and Povidone-iodine Groups.
Outcome measures
Outcome data not reported
Adverse Events
3M Skin and Nasal Antiseptic
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Bactroban Nasal
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3M Skin and Nasal Antiseptic
n=842 participants at risk
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
|
Bactroban Nasal
n=855 participants at risk
Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.
|
|---|---|---|
|
Vascular disorders
Headache
|
0.24%
2/842 • Number of events 2 • 3 months
|
1.8%
15/855 • Number of events 15 • 3 months
|
|
General disorders
Rhinorrhea
|
0.12%
1/842 • Number of events 1 • 3 months
|
5.5%
47/855 • Number of events 47 • 3 months
|
|
General disorders
Nasal irritation
|
0.95%
8/842 • Number of events 8 • 3 months
|
1.5%
13/855 • Number of events 13 • 3 months
|
|
General disorders
Congestion
|
0.36%
3/842 • Number of events 3 • 3 months
|
1.8%
15/855 • Number of events 15 • 3 months
|
|
General disorders
Cough
|
0.36%
3/842 • Number of events 3 • 3 months
|
0.70%
6/855 • Number of events 6 • 3 months
|
|
General disorders
Pharyngeal pain
|
0.00%
0/842 • 3 months
|
1.2%
10/855 • Number of events 10 • 3 months
|
Additional Information
Dr. Michael Phillips
New York University School of Medicine
Phone: 212 263 4316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place