CLINICAL TRIALS PROFILE FOR TOBRAMYCIN SULFATE (PHARMACY BULK)
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All Clinical Trials for TOBRAMYCIN SULFATE (PHARMACY BULK)
| 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. |
| NCT05279586 ↗ | Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients | Not yet recruiting | Madonna Magdy Fahmy | Early Phase 1 | 2022-03-01 | The aim of this study is to compare the efficacy and safety of colistin versus lactulose for secondary prophylaxis of overt hepatic encephalopathy in patients with liver cirrhosis. |
| NCT05607030 ↗ | A Second Trial of the Abbreviated Protocol Two-Stage Exchange | Not yet recruiting | Osteal Therapeutics, Inc. | Phase 2 | 2022-11-30 | Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of PJI, absence of continued antiobiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, 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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