- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194541
Wound Dressings for Hidradenitis Suppurativa
March 10, 2023 updated by: Hadar Lev-Tov, University of Miami
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
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.
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Wound dressing applied and changed as needed.
Wound dressing applied and changed as needed.
Wound dressing applied and changed as needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dermatology Life Quality Index (DLQI) Scores
Time Frame: At Baseline, at 6 Weeks
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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.
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At Baseline, at 6 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Time Frame: At Baseline, at 6 Weeks
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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.
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At Baseline, at 6 Weeks
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Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Time Frame: At Baseline, at 6 Weeks
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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.
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At Baseline, at 6 Weeks
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Sleep Rating
Time Frame: At Baseline, at 6 Weeks
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Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.
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At Baseline, at 6 Weeks
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Drainage Rating
Time Frame: At Baseline, at 6 Weeks
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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.
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At Baseline, at 6 Weeks
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Odor Rating
Time Frame: At Baseline, at 6 Weeks
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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.
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At Baseline, at 6 Weeks
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Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Time Frame: At 6 Weeks
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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.
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At 6 Weeks
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Average Frequency of Dressing Changes
Time Frame: 6 Weeks
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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.
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6 Weeks
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Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Time Frame: At Baseline
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Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.
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At Baseline
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Number of Participants Reporting Dressing Preference for Each Specific Body Part
Time Frame: Visit 1 (Day 14)
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Participant reported dressing preference for specific body parts for each of the interventions received.
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Visit 1 (Day 14)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hadar Lev-Tov, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2020
Primary Completion (Actual)
March 8, 2021
Study Completion (Actual)
March 8, 2021
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 9, 2019
First Posted (Actual)
December 11, 2019
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20191046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Austria, Belgium, Canada, Germany, Poland, Spain, Australia, Denmark, France, United Kingdom, Japan, Bulgaria, Netherlands, Czechia, Greece, Italy
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Association pour la Recherche Clinique et ImmunologiqueNot yet recruitingHidradenitis Suppurativa (HS)
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