Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
vancomycin hydrochloride and tobramycin sulfate via local irrigation
Covenant Hospital
Saginaw, Michigan, United States
Ortho Carolina Research Institute
Charlotte, North Carolina, United States
SSM Health Bone and Joint Hospital at St. Anthony
Oklahoma City, Oklahoma, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Time frame: 12 months
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