A Comparison of Chlorhexadine Gluconate Versus Povidone Iodine Surgical Preparation in Skin Bacterial Colony Counts for Elective Knee Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.
研究概览
简要总结
This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements.
Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.
详细描述
Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.
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
- •Scheduled to undergo primary total knee arthroplasty
- •Age 18 or over
排除标准
- •Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
- •Age 17 or younger
- •Allergies to chlorhexadine gluconate or povidone iodine
- •Topical antimicrobial use within 14 days of surgery
- •Any active dermatoses or open wounds over the operative site
- •Any condition requiring antibiotics 14 days prior to arriving for surgery
- •Patients with chronic immunosuppression (such as HIV/AIDS)
- •Unable to adhere to follow up schedule and treatment
研究组 & 干预措施
Arm 1
Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.
干预措施: Swab area with Betadine (Drug)
Arm 2
Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.
干预措施: Swab area with ChloraPrep (Drug)
结局指标
主要结局
Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.
时间窗: 24 hours
Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.
次要结局
未报告次要终点