Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
研究概览
简要总结
The purpose of the study is to determine the prevalence of anal erosions within a 14 day period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal management systems (FMS).
Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal management systems in a 14 day period.
Alternative Hypothesis: One fecal management system is no worse than the second fecal management system in the development of anal erosion.
详细描述
PURPOSE: To compare the incidence of anal erosion between 2 indwelling fecal management systems. Anal erosion was defi ned as localized mucous membrane tissue impairments of the anal canal caused by corrosive fecal enzymes and/or indwelling devices. DESIGN: Randomized comparative effectiveness clinical trial comparing 2 commercially available indwelling fecal management systems. SUBJECTS AND SETTING: The target population was adults cared for on medical, surgical, and neurological intensive care units (ICUs) and non-ICU units with an order for indwelling fecal management system placement. The research setting was a 1200-bed quaternary-care medical center in the Midwestern United States. 90 patients were enrolled in the study. The number who started and completed the study; 41 of 47 received system A and 38 of 43 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Bedfast patients who need to have liquid or semi-liquid stool contained away from the body to prevent skin breakdown or contamination of existing wounds
- •Liquid to semi-liquid stool incontinence for past three days that is expected to last for extended period due to poor response to anti-diarrheal treatment
- •Absence of contraindications listed in Exclusion Criteria
- •If on subcutaneous anti-coagulation to prevent deep vein thrombosis, then can be included in study
排除标准
- •Allergic to product components
- •Rectal or anal injury or active bleeding
- •Severe rectal or anal stricture or stenosis (distal rectum cannot accommodate the balloon), diseases of the rectal mucosa (i.e. severe proctitis, ischemic proctitis, mucosal lacerations)
- •Rectal or anal tumors
- •Severe hemorrhoids
- •Fecal impaction
- •Loss of rectal tone or prolapsed anal sphincter
- •History of Ileo-anal anastamosis or internal rectal pouch (e.g. S or J pouch)
- •Large Bowel (Colon) surgery or rectal surgery within the last year
- •Currently on heparin drip
结局指标
主要结局
Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS
时间窗: up to 14 days
anal erosion within 14 days after insertion of FMS
次要结局
未报告次要终点
研究者
Nancy M. Albert, Ph.D.
Cleveland Clinic Foundation
The Cleveland Clinic