Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Sponsor
University of Iowa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04297592
Collaborator
(none)
956
4
2
59.7
239
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cephalexin Oral Tablet
  • Drug: Doxycycline Hyclate
Phase 4

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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
956 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Actual Study Start Date :
Jun 11, 2020
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Vibramycin
  • No Intervention: Group B - no additional antibiotic

    No antibiotics will be prescribed following standard perioperative IV antibiotics following primary hip or knee arthroplasty.

    Outcome Measures

    Primary Outcome Measures

    1. Periprosthetic joint infections [Within 90-days primary hip or knee arthroplasty]

      Defined by Musculoskeletal Infection Society (MSIS) criteria

    2. Periprosthetic joint infections [Within 1-year of primary hip or knee arthroplasty]

      Defined by Musculoskeletal Infection Society (MSIS) criteria

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Undergoing elective, primary total hip or total knee arthroplasty

    • Between the ages of 18-99

    • Has one or more of the following high risk criteria: body mass index (BMI) greater than 35kg/m^2, diagnosis of diabetes, active tobacco user, chronic kidney disease (estimated glomerular filtration (eGFR) < 60 mL/min/1.73 m2), nasal colonization of MRSA and/or MSSA or autoimmune/inflammatory disease.

    Exclusion Criteria:
    • Younger than 18 years old

    • Undergoing a revision hip or knee arthroplasty

    • Will have a subsequent total joint arthroplasty performed within 12 weeks of study enrollment

    • Patient is discharged the same day as primary THA or TKA

    • History of clostridium difficile colitis

    • Undergoing non-elective procedure

    • Hemiarthroplasty

    • Unicompartmental knee arthroplasty

    • Simultaneous bilateral total hip or knee arthroplasty

    • Pregnant

    • Unable to provide written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    3 Mayo Clinic Rochester Minnesota United States 55902
    4 West Virginia University Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • University of Iowa

    Investigators

    • Principal Investigator: Jacob Elkins, MD, University of Iowa Hospitals & Clinics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jacob M. Elkins, Dr. Jacob Elkins, MD, PhD, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT04297592
    Other Study ID Numbers:
    • 201912215
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jacob M. Elkins, Dr. Jacob Elkins, MD, PhD, University of Iowa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2022