Methicillin-resistant Staphylococcus Aureus, Orthopedic Procedures
Conditions
Keywords
MRSA colonization, Orthopedic Surgery, Altabax, Placebo
Brief summary
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
Detailed description
Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.
Interventions
DRUGPlacebo
Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
DRUGAltabax (retapamulin)
Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
Sponsors
Bay Pines VA Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients who are admitted for an orthopedic surgical procedure * All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA
Exclusion criteria
* Pregnancy * Serious systemic illness due to renal, cardiac or hepatic disease * Inability to complete follow-up assessments * Allergy or intolerance to retapamulin * BMI \> 30 * Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy * Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled * Antibiotics administered during the course of the study will be recorded (name, dose and dates)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Identify a predominant clone among the MRSA isolates in this study | 2 years |
Countries
United States
Outcome results
None listed