Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

Scotiaderm

Status: Not yet enrolling

Conditions: Incontinence-associated Dermatitis; Intertrigo; Moisture Associated Skin Damage

Treatments: Other: Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT05760469

Seeing Red

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Screening Rash

Other group

Description:

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.

Treatment:

Other: Screening