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临床试验/NCT02991833
NCT02991833已完成1 期

"Developing Of A New Incontinence Care Product, And Investigation Of The Effect Of Its On Perineal Dermatitis in Woman Patients Fecal Incontinence"

Ege University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
A New Incontinence Care Product associated dermatitis

研究概览

简要总结

The aim of this randomized controlled clinical trial, prospective study is to developing a new incontinece care product for containing the fecal incontinence and to examine the effect of this new product on prevention of perineal dermatitis.

详细描述

Urinary and faecal incontinence which affected the large number of people are common and embarrassing health problems. Urinary incontinence affects the life quality , and causes to isolation and depression. Faecal incontinence can cause to psychosocial problems such as loss of self-esteem, progressive isolation, social stigmatisation and reduces the life quality, also burden a high cost on the patients and the community . Both urinary and fecal incontinence may leads to incontinence-associated dermatitis (IAD), an inflamatory skin disease, which is a a clinical evolution of skin damage associated with moisture , as a result of chronic or repeated exposure of the skin to urine or fecal matter. In IAD shows as redness with or without blistering, erosion, or loss of the skin barrier function IAD which causes discomfort and stres for patients , is a serious and common problem in many health care setting and impacts patients' well-being. Health care professionals who are working in many health institutions struggled to giving the optimal care to keep incontinent patients' skin in a healthy condition. When IAD developed, the risk of infection, the length of hospitalization, and morbidity increases and those patients are at greater risk of developing a pressure ulser.

The research question was; are there differences in the incidence of IAD in patients with fecal incontinence by a new incontinece care versus adult diaper.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •bedridden patients who had fecal and urinary incontinence,
  • •had not diabetes mellitus,
  • •patients whose perineal and perianal skin is intact,
  • •had indwelling urethral catheter and
  • •patient who accepted to participate to the study

排除标准

  • •patients who had diabetes mellitus,
  • •patients whose had darkly pigmented area in the perineal and perianal area,
  • •patients had pressure ulcers or erithema
  • •who have not accepted to participate

研究组 & 干预措施

Of A New Incontinence Care Product

Experimental

Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product ( the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.

干预措施: A New Incontinence Care Product (Other)

Diaper

Active Comparator

Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper ) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.

干预措施: Diaper (Other)

结局指标

主要结局

A New Incontinence Care Product associated dermatitis

时间窗: 3 months

Women patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 days. The visual scale contrived by (Fader et al.(2003) which is based on International Contact Dermatit Score, was used for graded the severity of IAD. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased. To evaluate skin integrity, the perineal skin of the patients was observed every day by researcher and was recorded to the Perineal Skin Integrity Assesment Form. The number of defecation, stool consistency, and the number of care product (diaper and the novel incontinent care product) was observed daily and was recorded to the Patient Observation Form. The main study outcomes was IAD.We defined IAD having an erithema score of 1 or more, in the skin of buttock, sacrum, thight and groin.

次要结局

  • Diaper associated dermatitis(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leyla Khorshitd

PROFESSOR DR.

Ege University

研究点 (1)

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