Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

Completed

• Conditions: Orthopedic Operations
• Interventions: Drug: tobramycin

• Registration Number: NCT01938417
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Adult (> or =18 years old) patients
• Treatment with Osteoset® T

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Exclusion Criteria

• Intravenous tobramycin

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients treated with Osteoset® T (tobramycin sulfate)	tobramycin	10 g or 20 g of Osteoset® T

Primary Outcome Measures

Name	Time	Method
Measurement of systemic tobramycin concentration	within 10 days after surgery	Develop a population pharmacokinetic model for tobramycin in patients treated with an active calcium sulfate bone substitute and to predict tobramycin systemic exposure under various dose and renal function levels.