A Randomized Control Trial Evaluating the Efficacy of Extended Antibiotic Prophylaxis in Total Joint Arthroplasty for the Prevention of Surgical Site Infections
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
Introduction:
· Surgical site infections (SSIs) are persistent concerns in total joint arthroplasty (TJA).
· While antibiotic prophylaxis is crucial, the optimal duration remains controversial.
· This randomized controlled trial (RCT) aims to assess the efficacy of oral extended antibiotic prophylaxis in TJA for preventing SSIs when compared to the routine standard protocol.
· This study seeks to provide evidence for optimizing perioperative care, reducing SSIs and enhancing patient outcomes in knee arthroplasty surgery. By addressing this clinical conundrum, we hope to contribute valuable insights to perioperative protocols and ultimately improve the quality of care for TJA patients.
Aims and Objectives:
• To investigate whether extending the duration of oral antibiotic prophylaxis for 7 days in Total Joint arthroplasty - Hip and Knee reduces the incidence of peri-prosthetic joint infections (PJI) & surgical site infections (Test group) compared to standard perioperative antibiotic prophylaxis (Control group).
Objectives:
• To assess 90-day complication and readmission rates among both cohorts.
• Wound complications in both cohorts.
• Need for repeat oral antibiotic within follow-up duration.
• Rates of antibiotic resistance among isolated pathogens.
• Adverse effects related to extended antibiotic use.
HYPOTHESIS:
There is no difference in the incidence of peri-prosthetic joint infections (PJI) & surgical site infections on extending the duration of oral antibiotic prophylaxis for 7 days in Total joint arthroplasty compared to standard perioperative antibiotic prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing primary total hip and total knee arthroplasty.
- •Age between 18 and 80 years
- •No known contraindications to extended antibiotic use like allergy or hypersensitivity.
排除标准
- •Known allergy to Cephalosporins/Doxycycline.
- •History of recent systemic/ local infection
- •Concurrent systemic infections
- •h/o previous knee/ hip surgeries.
- •h/o prior intra-articular injections within 3 months
- •Inflammatory, post-traumatic arthritis
- •Patients on immune-suppressive medications including anti-cancer drugs, and steroids.
结局指标
主要结局
Primary Outcome:
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks
1. Incidence of PJI and surgical site infections within the 90-day postoperative period- based on 2018 MSIS- ICM criteria
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks
2. Incidence of Surgical Site Infection
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks
3. Incidence of Reoperation- due to any cause
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks
4. Incidence of stitch abscess
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks
次要结局
- Secondary Outcomes:(Need for repeat oral antibiotic within follow-up duration)
研究者
Dr Tarun Jayakumar
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals