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"

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.

Study Overview

• Status: Completed
• Conditions: Incontinence-associated Dermatitis; Nursing Care
• Intervention / Treatment: Other: A New Incontinence Care Product; Other: Diaper

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Of A New Incontinence Care Product; 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.	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.
Active Comparator: Diaper; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A New Incontinence Care Product associated dermatitis	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaper associated dermatitis	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.	3 months

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Director: LEYLA KHORSHID, Professor, Ege University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: fecal incontinence; care product; bowel incontinence
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Dermatitis; Fecal Incontinence
• Other Study ID Numbers: EGE.0.20.05.00/BOY/1718/99Z

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patients were observed and evaluated daily during the morning care between 08:00 AM - 8:30 AM for a maximum 7 daysThe 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. Scoring is is 0-to 4 and when scoring is increased the severity of the IAD increased.
• IPD Sharing Time Frame: 3 months
• IPD Sharing Access Criteria: perineal dermatitis, fecal incontinence