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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by 3M.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT01313182
First received: February 11, 2011
Last updated: March 14, 2011
Last verified: March 2011

February 11, 2011
March 14, 2011
March 2011
September 2012   (final data collection date for primary outcome measure)
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. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01313182 on ClinicalTrials.gov Archive Site
  • 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. [ Designated as safety issue: Yes ]
  • Measure rate of Staphylococcus aureus resistance to mupirocin.
Same as current
Not Provided
Not Provided
 
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Surgical Site Infection
  • 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
  • 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: 3M Skin and Nasal Antiseptic
    Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
    Intervention: Drug: Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation
  • Active Comparator: Bactroban Nasal
    Mupirocin calcium ointment, 2%
    Intervention: Drug: mupirocin calcium ointment, 2%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael Phillips, MD 212-263-5454 michael.phillips@nyumc.org
United States
 
NCT01313182
11318
No
Michael Phillips, MD, NYU Langone Center
3M
Not Provided
Not Provided
3M
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP