Incontinence-associated DermatitisEarly Phase 1NCT02991833
Developing Of A New Incontinence Care Product
A Early Phase 1 study testing A New Incontinence Care Product and Diaper in people with Incontinence-associated Dermatitis and Nursing Care, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Incontinence-associated Dermatitis, Nursing Care
- What is being tested?
- A New Incontinence Care Product and Diaper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to Jul 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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
- Being tested
- A New Incontinence Care Product, Diaper
- Keywords
- fecal incontinence, care product, bowel incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A New Incontinence Care ProductOther
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.
DiaperOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diaper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Khorshitd, Ege University
- Investigators
- LEYLA KHORSHID, Professor, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991833
- Sponsor's protocol ID
- EGE.0.20.05.00/BOY/1718/99Z
- Status last verified
- Oct 2017
- First submitted
- 6 Dec 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Developing Of A New Incontinence Care Product, And Investigation Of The Effect Of Its On Perineal Dermatitis in Woman Patients Fecal Incontinence"
- ClinicalTrials.gov ID
- NCT02991833
- Acronym / sponsor ID
- EGE.0.20.05.00/BOY/1718/99Z
- Conditions
- Incontinence-associated Dermatitis, Nursing Care
- Keywords
- fecal incontinence, care product, bowel incontinence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Of A New Incontinence Care Product | Experimental | Other: A New Incontinence Care ProductPatients 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. |
| Diaper | Active comparator | Other: DiaperPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A New Incontinence Care ProductThe 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 | Of A New Incontinence Care Product |
| DiaperIn 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. | Other | Diaper |
Primary outcome
A New Incontinence Care Product associated dermatitis
Time frame: 3 months
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.
1 secondary outcome
Diaper associated dermatitis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Incontinence-associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEYLA KHORSHID, Professor study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing A New Incontinence Care Product and Diaper in people with Incontinence-associated Dermatitis and Nursing Care, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A New Incontinence Care Product associated dermatitis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.