| Trial ID: | L1570 |
| Source ID: | NCT04297592
|
| Associated Drug: |
Cephalexin
|
| Title: |
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
|
| Acronym: |
|
| Status: |
ENROLLING_BY_INVITATION
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Infections Joint Prosthetic|Overweight or Obesity|MSSA Colonization|MRSA|Chronic Kidney Diseases|Diabetes|Autoimmune Diseases|Inflammatory Disease|Tobacco Use
|
| Interventions: |
DRUG: Cephalexin|DRUG: Doxycycline|DRUG: Cefadroxil
|
| Outcome Measures: |
Primary: Periprosthetic joint infections, Defined by Musculoskeletal Infection Society (MSIS) criteria, Within 90-days primary hip or knee arthroplasty|Periprosthetic joint infections, Defined by Musculoskeletal Infection Society (MSIS) criteria, Within 1-year of primary hip or knee arthroplasty | Secondary: Wound complication, Defined by at least one of the following: surgical wound dehiscence, skin necrosis at the surgical site, persistent surgical wound drainage (fluid extrusion from the operative site occurring beyond 72 hours from index surgery), superficial surgical site infection treated with new prescription of antibiotics or a change in study antibiotics but not meeting criteria for periprosthetic joint infection., Within 90 days of primary hip or knee arthroplasty
|
| Sponsor/Collaborators: |
Sponsor: Mayo Clinic
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
4618
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2020-06-11
|
| Completion Date: |
2026-06
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-27
|
| Locations: |
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States|Mayo Clinic, Rochester, Minnesota, 55902, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04297592
|
