Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites (NCT02436876) | Clinical Trial Compass
CompletedPhase 2
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
United States29 participantsStarted 2016-05-24
Plain-language summary
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* To be eligible for this study, each of the following criteria must be satisfied with a "YES" answer (unless not applicable):
Patients who:
* have had operative fracture fixation of the upper extremity (AO/OTA class 15, 11-13, 21-23), lower extremity (AO/OTA class 31-34, 41 44, 81, 82) or pelvis (61, 62), or have undergone arthrodesis, and have subsequently been diagnosed with an apparent fracture site infection or are diagnosed with chronic or acute-on-chronic osteomyelitis of the long bone extremities (including residual amputated limbs)
* have at least one of the following:
* require surgical debridement of infected soft tissue and/or bone, with or without removal and/or placement/replacement of hardware
* male or female between the ages of 18 and 75 at the time the ICF is reviewed and signed
* patients receiving or anticipated to receive systemic antibiotic therapy as per institution's standard of care
* patients requiring postoperative hospitalization for at least 48 hours after revision surgery
* have read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained
* be willing and able to provide authorization for use and disclosure of personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA)
Exclusion Criteria:
* To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer (unless not applicable):
* Patients who …