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Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin

This study has been completed.
Sponsor:
Collaborator:
New York University
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01313182
First received: February 11, 2011
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: February 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Surgical Site Infection
Interventions: Drug: mupirocin calcium ointment, 2%
Drug: Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only patients receiving surgery were considered Started.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    3M Skin and Nasal Antiseptic   Bactroban Nasal
STARTED   842   855 
COMPLETED   776   763 
NOT COMPLETED   66   92 
Protocol Violation                66                92 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
arthroplasty or spine fusion surgery patients

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   3M Skin and Nasal Antiseptic   Bactroban Nasal   Total 
Overall Participants Analyzed 
[Units: Participants]
 842   855   1697 
Age 
[Units: Years]
Mean (Full Range)
 61.8 
 (19.1 to 92.4) 
 62.4 
 (19.2 to 93.2) 
 62.1 
 (19.1 to 93.2) 
Gender 
[Units: Participants]
     
Female   499   523   1022 
Male   343   332   675 
Region of Enrollment 
[Units: Participants]
     
United States   842   855   1697 


  Outcome Measures

1.  Primary:   Surgical Site Infections Occurring Within 12 Months of Surgical Procedure   [ Time Frame: 12 months ]

2.  Secondary:   Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Measure Adverse Events Related to Mupirocin and Povidone-iodine.   [ Time Frame: At time of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.   [ Time Frame: Isolates collected and frozen ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study failed to achieve target enrollment. The small sample size precluded a multivariate analysis. Nasal culture alone was used as a screen for S. aureus colonization, which has a sensitivity of only 48% to 66%.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Phillips
Organization: New York University School of Medicine
phone: 212 263 4316
e-mail: michael.phillips@nyumc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01313182     History of Changes
Other Study ID Numbers: 11318
Study First Received: February 11, 2011
Results First Received: February 21, 2014
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board