Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- C.acnes Growth Rate
研究概览
简要总结
A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
详细描述
The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures
- •Patient can read and understand English
- •Patient who will undergo a primary shoulder arthroplasty
- •Patient is over the age of 18
排除标准
- •Patient who has had a previous surgery on the ipsilateral shoulder
- •Patient has a known allergy to topical iodine or Chlorohexidine gluconate.
- •Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery
- •Patient requires a revision procedure for a previous ipsilateral shoulder surgery
- •Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation
- •Patient is a pregnant woman
研究组 & 干预措施
Antiseptic Cleanser
Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval.
干预措施: Antiseptic Cleanser (Drug)
结局指标
主要结局
C.acnes Growth Rate
时间窗: 12 months
To compare the rate of C.acnes using two different antiseptic protocols
次要结局
- ROM(6 Months)
- American Shoulder and Elbow Surgeons Shoulder Score (ASES)(6 Months)
- Visual Analog Scale (VAS)(6 months)
研究者
Tim Lenters
Orthopedic Surgeon
Orthopaedic Associates of Michigan, PC