Back to resultsWound Dressings for Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cutimed Sorbact Hydroactive B wound dressing
Cutimed Siltect wound dressing
Sorbion Sana multi-star wound dressing
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04194541
Brief Title
Wound Dressings for Hidradenitis Suppurativa
Official Title
Wound Dressings for Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cutimed Sorbact Hydroactive B wound dressing
Intervention Description
Wound dressing applied and changed as needed.
Intervention Type
Device
Intervention Name(s)
Cutimed Siltect wound dressing
Intervention Description
Wound dressing applied and changed as needed.
Intervention Type
Device
Intervention Name(s)
Sorbion Sana multi-star wound dressing
Intervention Description
Wound dressing applied and changed as needed.
Primary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI) Scores
Description
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.
Time Frame
At Baseline, at 6 Weeks
Secondary Outcome Measure Information:
Title
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Description
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.
Time Frame
At Baseline, at 6 Weeks
Title
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Description
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.
Time Frame
At Baseline, at 6 Weeks
Title
Sleep Rating
Description
Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.
Time Frame
At Baseline, at 6 Weeks
Title
Drainage Rating
Description
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.
Time Frame
At Baseline, at 6 Weeks
Title
Odor Rating
Description
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.
Time Frame
At Baseline, at 6 Weeks
Title
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Description
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.
Time Frame
At 6 Weeks
Title
Average Frequency of Dressing Changes
Description
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.
Time Frame
6 Weeks
Title
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Description
Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.
Time Frame
At Baseline
Title
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Description
Participant reported dressing preference for specific body parts for each of the interventions received.
Time Frame
Visit 1 (Day 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wound Dressings for Hidradenitis Suppurativa
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