Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 4,618
- 试验地点
- 2
- 主要终点
- Periprosthetic joint infections
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).
- •Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria:
- •Body mass index (BMI) > 35 kg/m^2;
- •Diagnosis of diabetes mellitus;
- •Active tobacco smoker;
- •Chronic kidney disease;
- •Autoimmune disease;
- •Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).
排除标准
- •Inability to consume oral antibiotics.
- •Allergy to antibiotic alternatives in the protocol.
- •History of clostridium difficile colitis.
- •Revision hip or knee arthroplasty procedure.
- •Non-elective surgery.
- •Hemiarthroplasty.
- •Unicompartmental knee arthroplasty.
- •Simultaneous bilateral THA or TKA.
- •Will have subsequent THA or TKA within 12 weeks of the index study procedure.
- •Pregnant.
研究组 & 干预措施
Additional Antibiotic Group
Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
干预措施: Cephalexin (Drug)
Additional Antibiotic Group
Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
干预措施: Cefadroxil (Drug)
Additional Antibiotic Group
Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
干预措施: Doxycycline (Drug)
结局指标
主要结局
Periprosthetic joint infections
时间窗: Within 1-year of primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Periprosthetic joint infections
时间窗: Within 90-days primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
次要结局
- Wound complication(Within 90 days of primary hip or knee arthroplasty)
研究者
Nicholas A. Bedard
Principal Investigator
Mayo Clinic