Cephalexin
Drug500 mg oral tablet, 4 times daily for 7 days
Other names: Keflex
NCT Number: NCT04297592
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Phase 4
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg oral tablet, 4 times daily for 7 days
Other names: Keflex
100 mg oral tablet, 2 times daily for 7 days
500 mg oral tablet, 2 times daily for 7 days
Other names: Duricef
Time frame: Within 90-days primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Time frame: Within 1-year of primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Time frame: Within 90 days of primary hip or knee arthroplasty
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.
Mayo Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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