Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 03/31/2020 |
| Primero enviado: | 03/02/2020 |
| Inscripción estimada enviada: | 03/02/2020 |
| Publicado por primera vez: | 03/04/2020 |
| Última actualización enviada: | 04/01/2020 |
| Última actualización publicada: | 04/06/2020 |
| Fecha de inicio real del estudio: | 04/30/2020 |
| Fecha estimada de finalización primaria: | 04/30/2023 |
| Fecha estimada de finalización del estudio: | 05/31/2023 |
Condición o enfermedad
Intervención / tratamiento
Drug: Group A - antibiotic group
Drug: Group A - antibiotic group
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| 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: Group A - antibiotic group Default oral antibiotic option for participants in Group A. |
| No Intervention: Group B - no additional antibiotic No antibiotics will be prescribed following standard perioperative IV antibiotics following primary hip or knee arthroplasty. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | 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 |
Salir
Medidas de resultado primarias
1. Periprosthetic joint infections [Within 90-days primary hip or knee arthroplasty]
2. Periprosthetic joint infections [Within 1-year of primary hip or knee arthroplasty]
Medidas de resultado secundarias
1. Wound complication [Within 90 days of primary hip or knee arthroplasty]
