NCT04297592

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,618 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cephalexin	500 mg oral tablet, 4 times daily for 7 days
DRUG	Doxycycline	100 mg oral tablet, 2 times daily for 7 days
DRUG	Cefadroxil	500 mg oral tablet, 2 times daily for 7 days

Timeline

• Start date: 2020-06-11
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-03-05
• Last updated: 2025-07-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study