Garcia Ashlee, Fung Sally, Kennedy-Evans Karen Lou
Banner University Medical Center, Tucson, AZ.
Wounds. 2017 Dec;29(12):E132-E138.
According to the Wound Ostomy Continence Nursing Society's Continence Committee, the incidence of fecal incontinence (FI) can occur from 18% to 37% in an acute care setting. A stool management system has been designed to manage FI in bedridden patients and has proven to be efficacious in wound management and prevention and infection control, provide safer patient outcomes, and enhance ease of nursing.
This study aims to evaluate the safety and efficacy of an intrarectal device intended to manage fecal incontinence in hospitalized bedridden patients through nonclinical and clinical testings.
An uncontrolled pilot evaluation in 20 patients was performed as part of a value-based purchasing evaluation at a tertiary hospital in Tucson, Arizona, to assess safety and efficacy in infection control and wound care. The company-provided engineering bench-top studies of insertion and withdrawal forces of the device versus existing intrarectal balloon catheters also were evaluated.
The device has broader patient eligibility and potentially allows 3 times more FI patients to be managed safely. It has lower intrarectal pressures compared with indwelling balloon catheters.
This study, along with pilot clinical findings, suggests that this technology minimizes the pressure exerted on the rectal wall. There were significantly fewer forces against the anorectal mucosa compared with the cuff-based catheter during insertion, withdrawal, and accidental expulsion.
根据伤口造口失禁护理协会的失禁委员会的数据，在急性护理环境中，大便失禁（FI）的发生率可能在18%至37%之间。一种大便管理系统已被设计用于管理卧床患者的大便失禁，并已被证明在伤口管理、预防和感染控制方面有效，能提供更安全的患者治疗结果，并提高护理的便利性。
本研究旨在通过非临床和临床测试，评估一种旨在管理住院卧床患者大便失禁的直肠内装置的安全性和有效性。
在亚利桑那州图森市的一家三级医院进行了一项针对20名患者的非对照试点评估，作为基于价值的采购评估的一部分，以评估在感染控制和伤口护理方面的安全性和有效性。还评估了该公司提供的关于该装置与现有直肠内球囊导管的插入和拔出力的工程台式研究。
该装置具有更广泛的患者适用性，并且可能使安全管理的大便失禁患者数量增加两倍。与留置球囊导管相比，其直肠内压力更低。
这项研究以及初步临床结果表明，该技术可将施加在直肠壁上的压力降至最低。在插入、拔出和意外排出过程中，与基于袖带的导管相比，对肛管直肠黏膜的作用力明显更少。
