CLINICAL TRIALS PROFILE FOR TOBRAMYCIN SULFATE
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All Clinical Trials for TOBRAMYCIN SULFATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01938417 ↗ | 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). | |
| NCT03308253 ↗ | 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. |
| NCT04662632 ↗ | Abbreviated Protocol for Two-Stage Exchange | Recruiting | Joint Purification Systems | Phase 2 | 2021-07-01 | 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. |
| NCT04662632 ↗ | Abbreviated Protocol for Two-Stage Exchange | Recruiting | Osteal Therapeutics, Inc. | Phase 2 | 2021-07-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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