Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

September 10, 2013 updated by: Francoise Livio, MD, University of Lausanne Hospitals
This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients treated with Osteoset® T in our orthopedic surgery department

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Intravenous tobramycin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult patients treated with Osteoset® T (tobramycin sulfate)
10 g or 20 g of Osteoset® T
Drug: tobramycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of systemic tobramycin concentration
Time Frame: 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.
within 10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tobramycin cast

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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