Hidradenitis SuppurativaNCT04194541
Wound Dressings for Hidradenitis Suppurativa
A study testing Cutimed Sorbact Hydroactive B wound dressing, Cutimed Siltect wound dressing and Sorbion Sana multi-star wound dressing in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Cutimed Sorbact Hydroactive B wound dressing, Cutimed Siltect wound dressing and Sorbion Sana multi-star wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects younger than 18-years-old.
- Prisoners
- Pregnant or lactating women
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Cutimed Sorbact Hydroactive B wound dressing, Cutimed Siltect wound dressing, Sorbion Sana multi-star wound dressing
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutimed Sorbact Hydroactive B wound dressingDevice
Wound dressing applied and changed as needed.
Cutimed Siltect wound dressingDevice
Wound dressing applied and changed as needed.
Sorbion Sana multi-star wound dressingDevice
Wound dressing applied and changed as needed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Cutimed Sorbact Hydroactive B wound dressing; Device: Cutimed Siltect wound dressing; Device: Sorbion Sana multi-star wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Baseline, at 6 Weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start28 Jan 2020
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194541
- Sponsor's protocol ID
- 20191046
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2019
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Dressings for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04194541
- Acronym / sponsor ID
- 20191046
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Cutimed Sorbact Hydroactive B wound dressing, Device: Cutimed Siltect wound dressing, Device: Sorbion Sana multi-star wound dressingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Subjects younger than 18-years-old.
- Prisoners
- Pregnant or lactating women
- Adults unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutimed Sorbact Hydroactive B wound dressingWound dressing applied and changed as needed. | Device | Treatment Group |
| Cutimed Siltect wound dressingWound dressing applied and changed as needed. | Device | Treatment Group |
| Sorbion Sana multi-star wound dressingWound dressing applied and changed as needed. | Device | Treatment Group |
Primary outcome
Dermatology Life Quality Index (DLQI) Scores
Time frame: At Baseline, at 6 Weeks
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.
9 secondary outcomes
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Time frame: At Baseline, at 6 Weeks
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Time frame: At Baseline, at 6 Weeks
Sleep Rating
Time frame: At Baseline, at 6 Weeks
Drainage Rating
Time frame: At Baseline, at 6 Weeks
Odor Rating
Time frame: At Baseline, at 6 Weeks
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Time frame: At 6 Weeks
Average Frequency of Dressing Changes
Time frame: 6 Weeks
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Time frame: At Baseline
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Time frame: Visit 1 (Day 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutimed Sorbact Hydroactive B wound dressing, Cutimed Siltect wound dressing and Sorbion Sana multi-star wound dressing in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) Scores (time frame: At Baseline, at 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.