TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 174
- 主要终点
- Follow up for infected patients after 90 days with surgical site infection.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.
详细描述
Periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (TJA), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. Surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent .
Despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. Thus, there is significant interest in developing and systematically evaluating new PJI prophylaxis measures to reduce this rate.
Historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. The earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. The use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). Similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery.
Importantly, data on topical vancomycin powder used alone remain inconclusive for TJA, with some stating that it may increase aseptic wound complications, and others stating that it reduces PJI significantly .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients population who will undergo primary total knee or total hip arthroplasty
排除标准
- •patients with diabetes mellitus inflammatory arthritis diseases smokers BMI > 40
研究组 & 干预措施
Vancomycin loaded group
applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations
干预措施: Vancomycin (Drug)
Vancomycin loaded group
applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations
干预措施: Total knee or total hip arthroplasty (Procedure)
Non vancomycin loaded group
Total knee & hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group
干预措施: Total knee or total hip arthroplasty (Procedure)
结局指标
主要结局
Follow up for infected patients after 90 days with surgical site infection.
时间窗: 3 months after operation
The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.
次要结局
- Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.(3 months)
研究者
Maro Maher Botros Boktor
Resident physician at Orthopedic& Trauma department,principal investigator
Assiut University