Incontinence-associated DermatitisNCT05760469
Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support
A study testing Screening in people with Incontinence-associated Dermatitis and Moisture Associated Skin Damage, run by Scotiaderm.
Trial summary
This research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (IAD) and intertrigo (ITD)) at Valley Regional Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis, Moisture Associated Skin Damage, Intertrigo
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Sep 2024
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- Intertrigo (ITD) and or incontinence-associated dermatitis (IAD)
- Expected length of stay of seven (7) days
- life expectancy greater than one week
- written informed consent by the patient or his/her representative including explicit consent to take daily photographs of the rash associated with MASD.
Who cannot join
- known allergy to standard MASD treatments
- life expectancy less than seven days
- complex skin disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Seeing Red: Towards Improving 'Recognition, Documentation and Outcome 'Measurement of Incontinence-associated 'Dermatitis and Intertrigo
This research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (IAD) and intertrigo (ITD)) at Valley Regional Hospital.
This is an exploratory study to assess the utility and accuracy of a structured documentation tool for IAD and ITD in hospitals. Current documentation involves a mostly verbal description of the location, size, and general features of the rash. Without a standardized approach to documentation, it can be challenging to accurately evaluate the evolution of the rash and the response to treatment from day to day and from different nurses. The reliability of the documentation tool will be assessed by comparing the results of the bedside assessment tool with that completed by wound care experts using standardized digital live photographs. The utility documentation tool from a nursing perspective will also be assessed using a structured questionnaire. Analysis of digital live photographs using a standard algorithm will be done to determine whether such an analysis can objectively and accurately track the healing of moisture-associated skin damage.
- Being tested
- Screening
- Medical subject headings
- Intertrigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Clinical nurse (CN) notifies research coordinator (RC) about patients with rashes. RC assesses eligibility criteria of patient based on inclusion criteria. RC provide CN with appropriate documentation tool (DT), smart device (SD), standardized red adhesive label (SRAL), and adhesive QRcode. Intervention: With written informed consent, demographic information will be collected. QRcode adhesive will be placed in the DT to track subject documentation throughout the study. Baseline live photograph (LP) of the rash will be taken with SD at day 0. LP will be taken daily. A SRAL, and a QR adhesive code will be included in the LP. LP will be automatically saved in a secure file on the cloud server under the QR code. CN will complete the DT for all rashes included in the study. Treatment of the rash will be at the discretion of the clinical team; the treatment regimen will be recorded daily. The procedure will be repeated daily for all rashes during the patient stay to a maximum of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Screening Rash | Other | This is an exploratory study to assess the usefulness and reliability of the ITD-IAD-M for diagnosing, tracking, and treating IAD and ITD in hospitals.Participants for the study will be identified by nursing staff from admitted patients. After informed consent, the primary care nurse will collect qualitative information from the patient based on the history of their skin condition, whether the rash is new or recurring for them, and their pain, irritation, and discomfort measures. All patients participating in the study will receive the standard of care for patients presenting with MASD as prescribed by their primary care physician. The nurse will complete the ITD-IAD-M tool daily along with routine patient care. Each day the nurse documents the rash status and whether the treatment can be stopped based on the nursing assessment. The nurse/research assistant will also take a standardized digital live picture of the rash (without any identifying features) daily for a maximum of 7 days. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITD-IAD-M Assessment tool
The primary outcome measurement is the correlation between the assessment of the rash by the primary care nurse and the assessment by the wound care expert, with respect to the categorization of the rash, the surface area involvement, and the timing of termination of treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startMay 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
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.
- 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Data for this study will be collected daily until you are discharged from the hospital, up to a maximum of 7 days. Study data will be collected by the nurses/research assistants during regular patient check-ins and will require minimal time to complete (15-20min maximum). Participants for the study will be identified by nursing staff from patients admitted to the Valley Regional Hospital. After informed consent, where possible, the primary care nurse will collect qualitative information from the patient based on the history of their skin condition, whether the rash is new or recurring for them, and their pain, irritation, and discomfort measures. All patients participating in the study will receive the standard of care for patients presenting with MASD as prescribed by their primary care physician.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scotiaderm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760469
- Sponsor's protocol ID
- Seeing Red
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeing Red: Towards Improving 'Recognition, Documentation and Outcome 'Measurement of Incontinence-associated 'Dermatitis and Intertrigo
- ClinicalTrials.gov ID
- NCT05760469
- Acronym / sponsor ID
- Seeing Red
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ScotiadermUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Mar 2023 (actual)
- 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.
This research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (IAD) and intertrigo (ITD)) at Valley Regional Hospital.
This is an exploratory study to assess the utility and accuracy of a structured documentation tool for IAD and ITD in hospitals. Current documentation involves a mostly verbal description of the location, size, and general features of the rash. Without a standardized approach to documentation, it can be challenging to accurately evaluate the evolution of the rash and the response to treatment from day to day and from different nurses. The reliability of the documentation tool will be assessed by comparing the results of the bedside assessment tool with that completed by wound care experts using standardized digital live photographs. The utility documentation tool from a nursing perspective will also be assessed using a structured questionnaire. Analysis of digital live photographs using a standard algorithm will be done to determine whether such an analysis can objectively and accurately track the healing of moisture-associated skin damage.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data for this study will be collected daily until you are discharged from the hospital, up to a maximum of 7 days. Study data will be collected by the nurses/research assistants during regular patient check-ins and will require minimal time to complete (15-20min maximum). Participants for the study will be identified by nursing staff from patients admitted to the Valley Regional Hospital. After informed consent, where possible, the primary care nurse will collect qualitative information from the patient based on the history of their skin condition, whether the rash is new or recurring for them, and their pain, irritation, and discomfort measures. All patients participating in the study will receive the standard of care for patients presenting with MASD as prescribed by their primary care physician.
| Arm | Type | Receives |
|---|---|---|
| Screening Rash | Other | Other: ScreeningThis is an exploratory study to assess the usefulness and reliability of the ITD-IAD-M for diagnosing, tracking, and treating IAD and ITD in hospitals.Participants for the study will be identified by nursing staff from admitted patients. After informed consent, the primary care nurse will collect qualitative information from the patient based on the history of their skin condition, whether the rash is new or recurring for them, and their pain, irritation, and discomfort measures. All patients participating in the study will receive the standard of care for patients presenting with MASD as prescribed by their primary care physician. The nurse will complete the ITD-IAD-M tool daily along with routine patient care. Each day the nurse documents the rash status and whether the treatment can be stopped based on the nursing assessment. The nurse/research assistant will also take a standardized digital live picture of the rash (without any identifying features) daily for a maximum of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years
- Intertrigo (ITD) and or incontinence-associated dermatitis (IAD)
- Expected length of stay of seven (7) days
- life expectancy greater than one week
- written informed consent by the patient or his/her representative including explicit consent to take daily photographs of the rash associated with MASD.
Key exclusion criteria (3 listed)
- known allergy to standard MASD treatments
- life expectancy less than seven days
- complex skin disorders
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 |
|---|---|---|
| ScreeningClinical nurse (CN) notifies research coordinator (RC) about patients with rashes. RC assesses eligibility criteria of patient based on inclusion criteria. RC provide CN with appropriate documentation tool (DT), smart device (SD), standardized red adhesive label (SRAL), and adhesive QRcode. Intervention: With written informed consent, demographic information will be collected. QRcode adhesive will be placed in the DT to track subject documentation throughout the study. Baseline live photograph (LP) of the rash will be taken with SD at day 0. LP will be taken daily. A SRAL, and a QR adhesive code will be included in the LP. LP will be automatically saved in a secure file on the cloud server under the QR code. CN will complete the DT for all rashes included in the study. Treatment of the rash will be at the discretion of the clinical team; the treatment regimen will be recorded daily. The procedure will be repeated daily for all rashes during the patient stay to a maximum of 7 days. | Other | Screening Rash |
Primary outcome
ITD-IAD-M Assessment tool
Time frame: 7 days
The primary outcome measurement is the correlation between the assessment of the rash by the primary care nurse and the assessment by the wound care expert, with respect to the categorization of the rash, the surface area involvement, and the timing of termination of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. The study data will not be shared with other researchers.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Incontinence-associated Dermatitis and Moisture Associated Skin Damage, run by Scotiaderm.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann K Gordon, MD (902-698-8372, dctrakg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITD-IAD-M Assessment tool (time frame: 7 days). 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 16 Apr 2024.