Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Autoimmune Diseases
- Chronic Kidney Diseases
- Diabetes
- Infections Joint Prosthetic
- Inflammatory Disease
- MRSA
- MSSA Colonization
- Overweight or Obesity
- Tobacco Use
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
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 populatio...
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.
Tracking Information
- NCT #
- NCT04297592
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicholas Bedard, MD University of Iowa Hospitals & Clinics