Wound Dressings for Hidradenitis Suppurativa

Study Overview
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Brief Summary
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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).

Official Title
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Wound Dressings for Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Device: Cutimed Sorbact Hydroactive B wound dressing
* Device: Cutimed Siltect wound dressing
* Device: Sorbion Sana multi-star wound dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Participants will be provided a kit containing 3 dressings: Cutimed Sorbact Hydroactive B, Cutimed Siltec, and Sorbion Sana multi-star. Participant can use their dressing of choice and can change their dressings as needed for 6 consecutive weeks. | Device: Cutimed Sorbact Hydroactive B wound dressing<br>* Wound dressing applied and changed as needed.<br>Device: Cutimed Siltect wound dressing<br>* Wound dressing applied and changed as needed.<br>Device: Sorbion Sana multi-star wound dressing<br>* Wound dressing applied and changed as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) |