Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 21,006
- 试验地点
- 2
- 主要终点
- The number of reoperations due to infection
研究概览
简要总结
Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.
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
- None
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
- •Patients 18 years of age or older.
- •Undergoing primary or aseptic revision TJR.
- •No contraindications to study interventions.
- •Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.
排除标准
- •Received antibiotics for any reason in the two weeks prior to their TJR.
- •Chronic or acute infection at or near the TJR site.
- •Prior history of periprosthetic joint infection including any reoperation due to infection.
- •Undergoing surgery for a diagnosis of a fracture.
- •Open infected wounds on affected limb.
- •Undergoing bilateral TJR.
- •Currently enrolled in a study that does not permit co-enrollment.
- •Prior enrollment in the trial including the pilot study
- •Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
研究组 & 干预措施
Chlorhexidine Gluconate 0.05% Lavage Solution
The study lavage solution (chlorhexidine-gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Chlorhexidine Gluconate (Drug)
Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin
The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Chlorhexidine Gluconate (Drug)
Povidone-Iodine 0.35% Lavage Solution
The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Povidone-Iodine (Other)
Povidone-Iodine 0.35% Lavage Solution and Vancomycin
The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Vancomycin Hydrochloride (Drug)
Saline Lavage Solution
The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.
The study lavage solution will be a total volume of 1 litre.
干预措施: Saline (Other)
Povidone-Iodine 0.35% Lavage Solution and Vancomycin
The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Povidone-Iodine (Other)
Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin
The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline.
干预措施: Vancomycin Hydrochloride (Drug)
Saline Lavage Solution and Vancomycin
The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.
Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
干预措施: Vancomycin Hydrochloride (Drug)
Saline Lavage Solution and Vancomycin
The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction.
Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure.
干预措施: Saline (Other)
结局指标
主要结局
The number of reoperations due to infection
时间窗: Within 1 year of total joint replacement
次要结局
- The number of non-operative surgical site infections requiring antibiotics for treatment.(Within 1 year of total joint replacement)