Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
NCT ID: NCT01313182
Last Updated: 2024-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
1874 participants
INTERVENTIONAL
2011-03-31
2012-09-30
Brief Summary
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Secondary study objectives include:
1. Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
2. Measure adverse events related to mupirocin and povidone-iodine.
3. Measure rate of SA resistance to mupirocin.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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3M Skin and Nasal Antiseptic
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
3M Skin and Nasal Antiseptic
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.
Interventions
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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.
3M Skin and Nasal Antiseptic
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than 18 years
Exclusion Criteria
* Revision spinal fusion surgery
* Primary spine surgery without implantation of prosthetic material
* Allergy to mupirocin
* Allergy to povidone-iodine
* Pregnancy
* Breastfeeding
18 Years
ALL
No
Sponsors
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New York University
OTHER
3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Center
Locations
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NYU Langone Medical Center
New York, New York, United States
Countries
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References
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Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.
Other Identifiers
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11318
Identifier Type: -
Identifier Source: org_study_id