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

NCT ID: NCT00903279

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

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.

Conditions

Orthopedic Procedures; Methicillin-resistant Staphylococcus Aureus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Altabax

Group Type: EXPERIMENTAL

Altabax (retapamulin)

Intervention Type: DRUG

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.

Interventions

Placebo

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.

Intervention Type: DRUG

Altabax (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.

Intervention Type: DRUG

Other Intervention Names

Retapamulin

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bay Pines VA Healthcare System

FED

Sponsor Role: lead

Responsible Party

Bay Pines VAHCS

Principal Investigators

Suzane Silbert, PhD

Role: STUDY_DIRECTOR

Bay Pines VAHCS

Locations

Bay Pines VAHCS

Bay Pines, Florida, United States

Countries

United States

Other Identifiers

TOPS2009

Identifier Type: -

Identifier Source: org_study_id