Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01313182|
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.
Secondary study objectives include:
- Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
- Measure adverse events related to mupirocin and povidone-iodine.
- Measure rate of SA resistance to mupirocin.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: mupirocin calcium ointment, 2% Drug: Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1784 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||March 2011|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
Active Comparator: 3M Skin and Nasal Antiseptic
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Drug: 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.
Other Name: 3M Skin and Nasal Antiseptic
Active Comparator: Bactroban Nasal
Mupirocin calcium ointment, 2%
Drug: 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.
Other Name: Bactroban Nasal
- Surgical Site Infections Occurring Within 12 Months of Surgical Procedure [ Time Frame: 12 months ]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.
- Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups. [ Time Frame: 12 months ]Re-admission for infection within 12 months of procedure
- Measure Adverse Events Related to Mupirocin and Povidone-iodine. [ Time Frame: At time of treatment ]Patients were given an adverse event log to complete after treatment
- Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. [ Time Frame: Isolates collected and frozen ]Lab will culture isolates when time and money permit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313182
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Michael Phillips, MD||NYU Langone Center|