To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the risk of periprosthetic joint infection or wound complications following surgery in a patient population that is high-risk for these complications. Patient with one or more of the following risk factors are considered high-risk for periprosthetic joint infection and/or wound complications: body mass index over 35kg/m\^2, diagnosis of diabetes, chronic kidney disease, active tobacco user, nasal colonization of methicillin-resistant Staphylococcus aureus and/or methicillin-sensitive Staphylococcus aureus, or autoimmune/inflammatory disease. Study participants will be randomized to either a 7-day course of an oral, prophylactic antibiotic following surgery or no additional antibiotic. All other standard perioperative total joint arthroplasty care will remain the same for both groups, including 24-hours of perioperative antibiotics. Outcomes assessed will include surgical wound complications occurring within 90-day of surgery and periprosthetic joint infection occurring within 90-day and 1-year of surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,618
500 mg oral tablet, 4 times daily for 7 days
100 mg oral tablet, 2 times daily for 7 days
500 mg oral tablet, 2 times daily for 7 days
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Mayo Clinic
Rochester, Minnesota, United States
Periprosthetic joint infections
Defined by Musculoskeletal Infection Society (MSIS) criteria
Time frame: Within 90-days primary hip or knee arthroplasty
Periprosthetic joint infections
Defined by Musculoskeletal Infection Society (MSIS) criteria
Time frame: Within 1-year of primary hip or knee arthroplasty
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.
Time frame: Within 90 days of primary hip or knee arthroplasty
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