NCT02991833

Developing Of A New Incontinence Care Product

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incontinence-associated Dermatitis
• Nursing Care

Interventions

Type	Name	Description
OTHER	A New Incontinence Care Product	The novel incontinent care product is dressed and removed removed by opening both sides. In the part surrounding the waist and thights of the novel incontinent care product flexibility is achieved by planting rubber bien. When developing new incontinence care products was taken counselling from a faculty member from Department of Textile Engineering of one University Faculty of Engineering. The insurance policies was prepared for each patients attended to the study (Number: 481360).New care product is put on the experimental group. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the novel incontinent care product was changed.
OTHER	Diaper	In patients of the diaper group was used the optimum adult diaper (Pads, Linea TENA, SCA, Hygiene, Goteborg, Sweden) which was available in the market. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the diaper was changed.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-07-01
• First posted: 2016-12-14
• Last updated: 2017-10-30

Locations

1 site across 1 country: Turkey (Türkiye)