Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial

Launched by DUKE UNIVERSITY · Sep 13, 2017

Keywords

ClinConnect Summary

The clinical trial titled "Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty" is studying how different methods of giving antibiotics before and after knee surgery might affect the risk of infections. Specifically, the researchers want to find out if giving a single dose of antibiotics right before the surgery is enough to prevent infections, or if giving antibiotics for a longer time after the surgery helps even more. The hope is to determine the best way to keep patients safe from infections during their recovery.

To participate in this trial, you need to be at least 18 years old and scheduled for a planned knee surgery due to conditions like arthritis. You should not have any open wounds or active infections in the leg that will be operated on. Participants can expect to follow a specific plan and attend scheduled visits to help the researchers gather important information. It's worth noting that Duke University is currently the only site for this study, so if you're interested, you might want to inquire there for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is ≥ 18 years of age
• • Patient has no open wounds on operative leg
• • Patient is scheduled to undergo elective total knee arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis
• • Patient does not have active infection on the operative leg, the operative joint
• • Patient is willing to cooperate and follow study protocol and visit schedule
• Exclusion Criteria:
• • Patient is ≤ 18 years of age
• • Patient is pregnant
• • Patient is unable to provide written consent
• • Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility
• • Patient has traumatic injury that requires emergent or urgent total knee arthroplasty (e.g. fracture)
• • Patient has active infections in the operative leg/joint
• • Patient has severe dementia
• • Suspicion of illicit drug abuse by patient. Patients who use prescription cannabinoids are not excluded from enrollment.
• • ASA score of 5 \& 6
• • No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound
• • Intra-operative re-dosing other than specified re-dosing intervals or without excessive blood loss (\<1500mL)
• • History of prior native septic knee arthritis