Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
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|ClinicalTrials.gov Identifier: NCT04297592|
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Infections Joint Prosthetic Overweight or Obesity MSSA Colonization MRSA Chronic Kidney Diseases Diabetes Autoimmune Diseases Inflammatory Disease Tobacco Use||Drug: Cephalexin Oral Tablet Drug: Doxycycline Hyclate||Phase 4|
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 perioperative intravenous 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 (Clinical Trial)|
|Estimated Enrollment :||956 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antibiotic Prophylaxis in High-Risk Arthroplasty Patients|
|Actual Study Start Date :||June 11, 2020|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||June 2025|
Active Comparator: Group A - antibiotic group
Patients will be given 7-days of an oral antibiotic (either cephalexin or doxycycline) to be started after completion of standard perioperative intravenous antibiotics following primary hip or knee arthroplasty
Drug: Cephalexin Oral Tablet
Default oral antibiotic option for participants in Group A.
Other Name: Keflex
Drug: Doxycycline Hyclate
Oral antibiotic option for participants in Group A if they have preoperative nasal colonization of methicillin-resistant Staphylococcus aureus, allergy to cephalosporins or a creatinine clearance less than 60 mL/min.
Other Name: Vibramycin
No Intervention: Group B - no additional antibiotic
No antibiotics will be prescribed following standard perioperative IV antibiotics following primary hip or knee arthroplasty.
- Periprosthetic joint infections [ Time Frame: Within 90-days primary hip or knee arthroplasty ]Defined by Musculoskeletal Infection Society (MSIS) criteria
- Periprosthetic joint infections [ Time Frame: Within 1-year of primary hip or knee arthroplasty ]Defined by Musculoskeletal Infection Society (MSIS) criteria
- Wound complication [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297592
|Contact: Lauren Keitel, BS||(319) email@example.com|
|Contact: Nicholas Bedard, MD||(319) firstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals & Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Lauren Keitel, BS 319-467-7128 email@example.com|
|Principal Investigator: Nicholas A Bedard, MD|
|Sub-Investigator: Martha Carvour, MD|
|United States, West Virginia|
|West Virginia University||Not yet recruiting|
|Morgantown, West Virginia, United States, 26506|
|Contact: Jennifer Eicher, BS 304-285-7445|
|Principal Investigator: Matthew Dietz, MD|
|Principal Investigator:||Nicholas Bedard, MD||University of Iowa Hospitals & Clinics|