Wound Dressings for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Wound Dressings for Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194541
• Other study ID #: 20191046
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women =18 years of age
• Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
• Presence of at least one lesion with active drainage
• Willing and able to provide informed consent

Exclusion Criteria:

• Subjects younger than 18-years-old.
• Prisoners
• Pregnant or lactating women
• Adults unable to consent

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Device:
• Cutimed Sorbact Hydroactive B wound dressing
Wound dressing applied and changed as needed.
• Cutimed Siltect wound dressing
Wound dressing applied and changed as needed.
• Sorbion Sana multi-star wound dressing
Wound dressing applied and changed as needed.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology Life Quality Index (DLQI) Scores	Participant quality of life as measured via DLQI. DLQI has a total score ranging from 0-30 with the higher score indicating more impairment on the participant's quality of life.	At Baseline, at 6 Weeks
Secondary	Average Pain as Assessed by the Numerical Rating Scale (NRS)	The average pain reported over the last 24 hours will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.	At Baseline, at 6 Weeks
Secondary	Maximal Pain as Assessed by the Numerical Rating Scale (NRS)	The pain rating at its worse over the last 24 hours will be reported as the maximal pain using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.	At Baseline, at 6 Weeks
Secondary	Sleep Rating	Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.	At Baseline, at 6 Weeks
Secondary	Drainage Rating	Lesion drainage rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion draining. For participants with multiple wounds/lesions, the drainage rating will be a comprehensive assessment of all wounds/lesions.	At Baseline, at 6 Weeks
Secondary	Odor Rating	Lesion odor rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion odor. For participants with multiple wounds/lesions, the odor rating will be a comprehensive assessment of all wounds/lesions.	At Baseline, at 6 Weeks
Secondary	Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading	HS-PGA Scale scores patient disease severity as one of the following: clear, minimal, mild, moderate, severe, and very severe. The number of participants scored at each scale will be reported.	At 6 Weeks
Secondary	Average Frequency of Dressing Changes	Participant reported frequency of dressing changes per wound per day. For participants with multiple wounds/lesions, the frequency of dressing changes will be a comprehensive assessment of all wounds/lesions.	6 Weeks
Secondary	Number of Participants Reporting Overall Dressing Preference for Specific Body Part	Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.	At Baseline
Secondary	Number of Participants Reporting Dressing Preference for Each Specific Body Part	Participant reported dressing preference for specific body parts for each of the interventions received.	Visit 1 (Day 14)