Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
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- STATUS
- Recruiting
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- End date
- Jun 24, 2025
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- participants needed
- 956
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- sponsor
- University of Iowa
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.
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.
Details
| Condition | Infections Joint Prosthetic, Overweight or Obesity, MSSA Colonization, MRSA, Chronic Kidney Diseases, Diabetes, Autoimmune Diseases, Inflammatory Disease, Tobacco Use |
|---|---|
| Treatment | Doxycycline Hyclate, Cephalexin Oral Tablet, Cephalexin Oral Tablet |
| Clinical Study Identifier | NCT04297592 |
| Sponsor | University of Iowa |
| Last Modified on | 24 March 2022 |
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