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

Information source: 3M
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Site Infection

Intervention: mupirocin calcium ointment, 2% (Drug); Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: 3M

Official(s) and/or principal investigator(s):
Michael Phillips, MD, Principal Investigator, Affiliation: NYU Langone Center


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: 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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Surgical Site Infections Occurring Within 12 Months of Surgical Procedure

Secondary outcome:

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 Staphylococcus Aureus Resistance to Mupirocin.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Primary arthroplasty or spinal fusion surgery

- Age greater than 18 years

Exclusion Criteria:

- Revision arthroplasty

- Revision spinal fusion surgery

- Primary spine surgery without implantation of prosthetic material

- Allergy to mupirocin

- Allergy to povidone-iodine

- Pregnancy

- Breastfeeding

Locations and Contacts

NYU Langone Medical Center, New York, New York 10003, United States
Additional Information

Starting date: March 2011
Last updated: April 24, 2014

Page last updated: August 23, 2015

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