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Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01938417
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Francoise Livio, MD, 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).

Condition or disease Intervention/treatment
Orthopedic Operations Drug: tobramycin

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2006
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients treated with Osteoset® T in our orthopedic surgery department

Inclusion Criteria:

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

Exclusion Criteria:

  • Intravenous tobramycin

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Francoise Livio, MD, Médecin associé, University of Lausanne Hospitals Identifier: NCT01938417    
Other Study ID Numbers: Tobramycin cast
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Keywords provided by Francoise Livio, MD, University of Lausanne Hospitals:
bone graft substitute
renal failure
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents