Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

June 26, 2023 updated by: Nicholas A. Bedard, Mayo Clinic
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

4618

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Additional Antibiotic Group
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.
Drug: Cephalexin
500 mg oral tablet, 4 times daily for 7 days
Other Names:
  • Keflex
Drug: Doxycycline
100 mg oral tablet, 2 times daily for 7 days
Drug: Cefadroxil
500 mg oral tablet, 2 times daily for 7 days
Other Names:
  • Duricef
No Intervention: Control Group - No Additional Antibiotic
Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprosthetic joint infections
Time Frame: Within 90-days primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Within 90-days primary hip or knee arthroplasty
Periprosthetic joint infections
Time Frame: Within 1-year of primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Within 1-year of primary hip or knee arthroplasty

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 90 days of primary hip or knee arthroplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Nicholas Bedard, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-001273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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