Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Diabetes Clinical Trial

Official title: Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Kidney Diseases
• Diabetes
• Infections Joint Prosthetic
• Inflammatory Disease
• Kidney Diseases
• MRSA
• MSSA Colonization
• Overweight
• Overweight or Obesity
• Renal Insufficiency, Chronic
• Tobacco Use

• NCT number: NCT04297592
• Study type: Interventional
• Source: Mayo Clinic
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 11, 2020
• Completion date: June 2025