Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery

Study Overview
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Brief Summary
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The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.

Detailed Description
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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.

Official Title
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Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)

Conditions
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Orthopedic Procedures, Methicillin-resistant Staphylococcus Aureus

Intervention / Treatment
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* Drug: Placebo
* Drug: Altabax (retapamulin)


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|
| Experimental: Altabax<br> | Drug: Altabax (retapamulin)<br>* 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.<br>* Other names: Retapamulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify a predominant clone among the MRSA isolates in this study |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRSA colonization, Orthopedic Surgery, Altabax, Placebo