Clinical trial NCT02991833: Developing Of A New Incontinence Care Product
Official title: "Developing Of A New Incontinence Care Product, And Investigation Of The Effect Of Its On Perineal Dermatitis in Woman Patients Fecal Incontinence"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Incontinence-associated Dermatitis
Nursing Care
Keywords: fecal incontinence
care product
bowel incontinence
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: A New Incontinence Care Product associated dermatitis
timeFrame: 3 months
Secondary outcomes:
measure: Diaper associated dermatitis
timeFrame: 3 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: LEYLA KHORSHID, Professor
role: STUDY_DIRECTOR
References: