Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT02991833
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Of A New Incontinence Care Product
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
"Developing Of A New Incontinence Care Product, And Investigation Of The Effect Of Its On Perineal Dermatitis in Woman Patients Fecal Incontinence"
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: