Developing Of A New Incontinence Care Product

NCT02991833 | Completed Early Phase 1

• 1 other identifier: EGE.0.20.05.00/BOY/1718/99Z
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence-associated Dermatitis; Nursing Care

Keywords

fecal incontinence; care product; bowel incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diaper associated dermatitis

  3 months

Study Arms (2)

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.

Other: A New Incontinence Care Product

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.

Other: Diaper

Interventions

A New Incontinence Care Product OTHER

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.

Of A New Incontinence Care Product

Diaper OTHER

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.

Diaper

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• LEYLA KHORSHID, Professor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR DR.

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 14, 2016
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3 months
• Access Criteria: perineal dermatitis, fecal incontinence

Locations

TU (1)