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Antibiotic Loaded Calcium Sulfate RCT

NCT03875963 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-18

No results posted yet for this study

Summary

This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.

Conditions

Interventions

OTHER

Antibiotic loaded bone filler

Defect management by placement of antibiotic loaded Stimulan as a bone void filler \[calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin\].

Sponsors & Collaborators

  • Biocomposites Ltd

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Emil Schemitsch, MD FRCS(C) · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-11-23
Completion
2022-11-23

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875963 on ClinicalTrials.gov