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Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

Seeing Red: Towards Improving 'Recognition, Documentation and Outcome 'Measurement of Incontinence-associated 'Dermatitis and Intertrigo

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05760469
Enrollment
20
Registered
2023-03-08
Start date
2024-05-31
Completion date
2024-09-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence-associated Dermatitis, Intertrigo, Moisture Associated Skin Damage

Brief 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. 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.

Interventions

OTHERScreening

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.

Sponsors

Scotiaderm
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* known allergy to standard MASD treatments * life expectancy less than seven days * complex skin disorders

Design outcomes

Primary

MeasureTime frameDescription
ITD-IAD-M Assessment tool7 daysThe 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.

Contacts

Primary ContactAnn K Gordon, MD
dctrakg@gmail.com902-698-8372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026