Clinical trial NCT05760469: Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support
Official title: Seeing Red: Towards Improving 'Recognition, Documentation and Outcome 'Measurement of Incontinence-associated 'Dermatitis and Intertrigo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Incontinence-associated Dermatitis
Moisture Associated Skin Damage
Intertrigo
Lead sponsor: Scotiaderm
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: ITD-IAD-M Assessment tool
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: