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

This study has been completed.
New York University
Information provided by (Responsible Party):
3M Identifier:
First received: February 11, 2011
Last updated: April 24, 2014
Last verified: April 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:

  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.

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

Resource links provided by NLM:

Further study details as provided by 3M:

Primary Outcome Measures:
  • Surgical Site Infections Occurring Within 12 Months of Surgical Procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Re-admission for infection within 12 months of procedure

  • Measure Adverse Events Related to Mupirocin and Povidone-iodine. [ Time Frame: At time of treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Lab will culture isolates when time and money permit

Enrollment: 1784
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01313182

United States, New York
NYU Langone Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
Principal Investigator: Michael Phillips, MD NYU Langone Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: 3M 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

Additional relevant MeSH terms:
Surgical Wound Infection
Pathologic Processes
Postoperative Complications
Wound Infection
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Blood Substitutes
Enzyme Inhibitors
Growth Substances
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Protein Synthesis Inhibitors
Therapeutic Uses
Trace Elements processed this record on May 05, 2016