Sammon Mary Ann, Montague Mary, Frame Fran, Guzman Deborah, Bena James F, Palascak Ann, Albert Nancy M
Mary Ann Sammon, BSN, WOCN, CWCN, Nursing Quality Management, Cleveland Clinic, Cleveland, Ohio. Mary Montague, MSN, APN, ACNS-BC, CWOCN, Nursing Quality Management, Cleveland Clinic, Cleveland, Ohio. Fran Frame, RN, Medical Intensive Care Unit, Cleveland Clinic, Cleveland, Ohio. Deborah Guzman, RN, Medical Intensive Care Unit, Cleveland Clinic, Cleveland, Ohio. James F. Bena, MS, Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. Ann Palascak, RN CWCN, Nursing Quality Management, Cleveland Clinic, Cleveland, Ohio. Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Office of Nursing Research and Innovation, Cleveland Clinic, Cleveland Ohio.
J Wound Ostomy Continence Nurs. 2015 May-Jun;42(3):279-86. doi: 10.1097/WON.0000000000000128.
To compare the incidence of anal erosion between 2 indwelling fecal management systems. Anal erosion was defined as localized mucous membrane tissue impairments of the anal canal caused by corrosive fecal enzymes and/or indwelling devices.
Randomized comparative effectiveness clinical trial comparing 2 commercially available indwelling fecal management systems.
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. Seventy-nine patients participated in the study; 41 received system A and 38 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.
Nurse researchers inserted 1 of 2 indwelling fecal management systems and assessed patients daily for anal erosion. Data were collected on patient demographics, medical history and insertion date, reason for the fecal management system, volume of water in balloon and balloon pressure daily, diet, body mass index, ease of insertion and removal, amount of resistance, and when and why the device was removed. Anecdotal comments from front-line staff nurses were also recorded. Occurrences of anal ulcer or erosion was compared using logistic regression models that adjusted for length of system use and time to event using Kaplan-Meier estimates and log rank tests.
The incidence of anal erosion was 12.7%. There were no differences in incidence of anal erosions between the 2 groups (12.2% vs 13.2% for systems A and B, respectively, P = .88), or in time to development of the erosions (P = .82). Leakage of stool occurred in 70% of patients and was associated with anal erosion (P = .027).
In this randomized comparative effectiveness research study, there was no difference in the incidence of anal erosion between groups. Purchasing decisions cannot be made based on differences in general product characteristics postulated to influence likelihood of anal erosion. Results regarding balloon water volume, mucosa pressure generated, and anal erosions require further study.
比较两种留置式粪便管理系统的肛管糜烂发生率。肛管糜烂定义为由腐蚀性粪便酶和/或留置装置引起的肛管局部黏膜组织损伤。
比较两种市售留置式粪便管理系统的随机对照有效性临床试验。
目标人群为在医疗、外科和神经科重症监护病房（ICU）以及非ICU病房接受护理且有留置式粪便管理系统安置医嘱的成年人。研究地点为美国中西部一家拥有1200张床位的四级医疗中心。79名患者参与了研究；41名接受系统A，38名接受系统B。受试者的平均年龄为64±13.6岁（均值±标准差），52%为女性。
护士研究人员插入两种留置式粪便管理系统中的一种，并每日评估患者的肛管糜烂情况。收集了患者的人口统计学资料、病史和插入日期、使用粪便管理系统的原因、球囊每日的注水量和球囊压力、饮食、体重指数、插入和取出的难易程度、阻力大小以及装置取出的时间和原因等数据。还记录了一线护士的轶事评论。使用逻辑回归模型比较肛管溃疡或糜烂的发生率，该模型对系统使用时长和事件发生时间进行了调整，采用Kaplan-Meier估计法和对数秩检验。
肛管糜烂发生率为12.7%。两组之间的肛管糜烂发生率无差异（系统A和B分别为12.2%和13.2%，P = 0.88），糜烂发生时间也无差异（P = 0.82）。70%的患者出现粪便渗漏，且与肛管糜烂相关（P = 0.027）。
在这项随机对照有效性研究中，两组之间的肛管糜烂发生率无差异。不能基于假定会影响肛管糜烂可能性的一般产品特征差异来做出购买决策。关于球囊注水量、产生的黏膜压力和肛管糜烂的结果需要进一步研究。
