Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Phase 4

• Conditions: Inflammatory Disease; Tobacco Use; Infections Joint Prosthetic; Overweight or Obesity; Autoimmune Diseases; MSSA Colonization; MRSA; Chronic Kidney Diseases; Diabetes
• Interventions: Drug: Cephalexin; Drug: Doxycycline; Drug: Cefadroxil

• Registration Number: NCT04297592
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Study Start: 2020-06-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4618

Inclusion Criteria

• Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).
• Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria:
• Body mass index (BMI) > 35 kg/m^2;
• Diagnosis of diabetes mellitus;
• Active tobacco smoker;
• Chronic kidney disease;
• Autoimmune disease;
• Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).

Exclusion Criteria

• Inability to consume oral antibiotics.
• Allergy to antibiotic alternatives in the protocol.
• History of clostridium difficile colitis.
• Revision hip or knee arthroplasty procedure.
• Non-elective surgery.
• Hemiarthroplasty.
• Unicompartmental knee arthroplasty.
• Simultaneous bilateral THA or TKA.
• Will have subsequent THA or TKA within 12 weeks of the index study procedure.
• Pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional Antibiotic Group	Cephalexin	Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
Additional Antibiotic Group	Doxycycline	Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
Additional Antibiotic Group	Cefadroxil	Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.

Primary Outcome Measures

Name	Time	Method
Periprosthetic joint infections	Within 1-year of primary hip or knee arthroplasty	Defined by Musculoskeletal Infection Society (MSIS) criteria

Secondary Outcome Measures

Name	Time	Method
Wound complication	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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States