MedDataX Logo

Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

NCT ID: NCT01938417

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthopedic Operations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

tobramycin bone graft substitute pharmacokinetics renal failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

adult patients treated with Osteoset® T (tobramycin sulfate)

10 g or 20 g of Osteoset® T

tobramycin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tobramycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Intravenous tobramycin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Francoise Livio, MD

Médecin associé

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Livio F, Wahl P, Csajka C, Gautier E, Buclin T. Tobramycin exposure from active calcium sulfate bone graft substitute. BMC Pharmacol Toxicol. 2014 Mar 4;15:12. doi: 10.1186/2050-6511-15-12.

Reference Type DERIVED
PMID: 24593819 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Tobramycin cast

Identifier Type: -

Identifier Source: org_study_id