Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

Incontinence-associated Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760469
• Other study ID #: Seeing Red
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Scotiaderm
• Contact: Ann K Gordon, MD
• Phone: 902-698-8372
• Email: dctrakg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis
• Intertrigo

Intervention

Other:
• Screening
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scotiaderm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days