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: April 24, 2014
Last verified: April 2014

February 11, 2011
April 24, 2014
March 2011
September 2012   (final data collection date for primary outcome measure)
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.
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 ]
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. [ 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
  • 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.
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%
Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1784
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 information is only displayed when the study is recruiting subjects
United States
 
NCT01313182
11318
No
3M
3M
New York University
Principal Investigator: Michael Phillips, MD NYU Langone Center
3M
April 2014

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