The Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture: A Cross-over, Cluster Randomized Controlled, Non-inferiority Trial Based on National Quality Databases: ProHipQ-F
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 72
- 主要终点
- Incidence of Prosthetic joint infections (PJI)
研究概览
简要总结
Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI after surgery in patients undergoing primary THA due to an acute fracture or sequelae of proximal femoral or acetabular fractures.
The study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 2,000 primary THAs due to a fracture or sequelae to a fracture, conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.
详细描述
The outcome measures will be extracted from the following national databases: The Civil Registration System (CRS), The Danish Hip Arthroplasty Register (DHR), The Danish National Patient Registry (DNRP), The Hospital Acquired Infections Database (HAIBA), The Danish National Prescription Database (NPR), Statistics Denmark and Danish Agency for Labour Market and Recruitment registry (STAR).
Details regarding the Arms and Interventions:
The preoperative dose of antibiotic must be administered prior to surgical incision and in cases of delay with regards to planned surgical incision:
Dicloxacillin/Cloxacillin: If the preoperative antibiotic dose is administered >60 minutes prior to surgical incision, the initial dose must be repeated.
Cefuroxime: If the preoperative antibiotic dose is administered >90 minutes prior to surgical incision, the initial dose must be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Blinding will not be applicable, because it is considered infeasible to expose participants and clinical personnel to this in either of the groups since any specific clinic will follow their allocated specific (single- or multiple-dose) routine during an entire 1-year period and their routine treatment of any complication (before switching).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients receiving a primary Total Hip Arthroplasty (THA) due to an acute- or sequelae of proximal femoral or acetabular fractures
排除标准
- •Patients receiving a primary THA due to bone tumor or metastasis
- •Patients receiving a primary THA due to osteoarthritis and all reasons according to the Danish Hip Arthroplasty Register (DHR) except conditions mentioned in the inclusion criteria
结局指标
主要结局
Incidence of Prosthetic joint infections (PJI)
时间窗: Within 90 days from index surgery
The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. 1. Two or more intraoperative deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples 2. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated 3. A PJI when an indication of deep infection is reported to The Danish Hip Arthroplasty Registry (DHR) by the surgeon upon revision surgery
次要结局
- Number of patients with one or more Serious Adverse Events (SAEs)(Within 90 days from index surgery)
- Incidence of Potential PJI referred to as PJI-likely(Within 90 days from index surgery)
- Length of hospital stay (LOS)(Within 90 days from index surgery)
- Incidence of Major Adverse Cardiovascular Events (MACE)(Within 90 days from index surgery)
- Hospital-treated infections (excluding Surgical Site infections)(Within 90 days from index surgery)
- Proportion of patients with at least one dispensing for antibiotic(Within 90 days from index surgery)
- Opioid use(Within 90 days from index surgery)
- Use of acetaminophen or non-steroidal anti-inflammatory drugs(Within 90 days from index surgery)
- Any revision after THA(Within 90 days from index surgery)
研究者
Soren Overgaard
Clinical Professor, DMSc
University Hospital Bispebjerg and Frederiksberg