Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 539
- 主要终点
- The incidence of periprosthetic infection.
研究概览
简要总结
Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.
详细描述
Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joint replacement surgery for any reason
- •18 years or older
排除标准
- •unable to comply with study requirements
- •were pregnant
- •were under the age of 18 years
- •medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
- •received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
- •chronic hepatitis B or C infection
- •had an infection in or around the joint requiring surgery.
研究组 & 干预措施
Primary Control TKA
Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
干预措施: Standard of care bathing with antibacterial soap and water (Other)
Primary Treatment TKA
Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
干预措施: chlorhexidine impregnated cloths (Other)
Revision Treatment TKA
Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.
干预措施: chlorhexidine impregnated cloths (Other)
Revision Control TKA
Patients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
干预措施: Standard of care bathing with antibacterial soap and water (Other)
Primary Control THA
Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
干预措施: Standard of care bathing with antibacterial soap and water (Other)
Primary Treatment THA
Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
干预措施: chlorhexidine impregnated cloths (Other)
Revision Control THA
Patients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
干预措施: Standard of care bathing with antibacterial soap and water (Other)
Revision Treatment THA
Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
干预措施: chlorhexidine impregnated cloths (Other)
结局指标
主要结局
The incidence of periprosthetic infection.
时间窗: One year
次要结局
未报告次要终点