Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute
Completed
University of Lausanne Hospitals
2006-10-01
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 for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection
Unknown status
McMaster University
Phase 4
2018-07-16
The CDC quotes a rate of wound infection of 2-5% for inpatient surgery. Patients undergoing a
vascular operation, however, are generally at an increased risk of wound infection with rates
often close to 5-10%. Groin incisions are an additional risk factor for surgical site
infections, with rates of wound infection being quoted from 10-15%, and even as high as 30%
in high risk patients. The use of implantable calcium sulfate beads mixed with antibiotics
may help to lower the rate of infection in these high risk patients.
Study Type: A multi-site, parallel group, randomized trial.
Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of
VT-X7. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint
of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2,
patient survival, absence of reoperation and absence of PJI. Secondary objectives are to
evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate
secondary endpoints for quality of life (QoL) and patient survival. The exploratory objective
is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
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