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Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297592
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Nicholas Bedard, University of Iowa

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
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023


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 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.



Primary Outcome Measures :
  1. Periprosthetic joint infections [ Time Frame: Within 90-days primary hip or knee arthroplasty ]
    Defined by Musculoskeletal Infection Society (MSIS) criteria

  2. Periprosthetic joint infections [ Time Frame: Within 1-year of primary hip or knee arthroplasty ]
    Defined by Musculoskeletal Infection Society (MSIS) criteria


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Lauren Keitel, BS (319) 467-7128 lauren-keitel@uiowa.edu
Contact: Nicholas Bedard, MD (319) 678-7947 nicholas-bedard@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Contact: Lauren Keitel, BS    319-467-7128    lauren-keitel@uiowa.edu   
Principal Investigator: Nicholas A Bedard, MD         
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Nicholas Bedard, MD University of Iowa Hospitals & Clinics
Publications:
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Responsible Party: Nicholas Bedard, Dr. Nicholas Bedard, MD, University of Iowa
ClinicalTrials.gov Identifier: NCT04297592    
Other Study ID Numbers: 201912215
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nicholas Bedard, University of Iowa:
total hip arthroplasty
total knee arthroplasty
hip replacement
knee replacement
periprosthetic joint infection
prophylaxis
antibiotics
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Autoimmune Diseases
Overweight
Urologic Diseases
Body Weight
Renal Insufficiency
Immune System Diseases
Doxycycline
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents