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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: June 11, 2013
Last verified: June 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Measure the rate of deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either product prior to surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Infections counted if within 12 months of surgical procedure


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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313182

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
3M
New York University
Investigators
Principal Investigator: Michael Phillips, MD NYU Langone Center
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01313182     History of Changes
Other Study ID Numbers: 11318
Study First Received: February 11, 2011
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Mupirocin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
 Blood Substitutes
Hematologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013