Hidradenitis SuppurativaNCT04449354
HidraWear Study for Hidradenitis Suppurativa Wounds
A study testing HidraWear Ax in people with Hidradenitis Suppurativa and Hidradenitis, run by HidraMed Solutions Ltd at 1 site in Ireland.
Trial summary
The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin for which there are limited wound dressing products. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Hidradenitis Suppurativa, Hidradenitis
- What is being tested?
- HidraWear Ax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIreland
- Study dates
- 30 Oct 2019to 3 Oct 2020
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form in English.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged >18
- Diagnosed with Hidradenitis Suppurativa
- Hidradenitis Suppurativa affecting the axilla
- Exuding lesion that requires wound dressings
Who cannot join
- 1. Recent surgery <3 months in axilla 2. Psoriasis, Dermatitis or skin conditions/rash other than Hidradenitis Suppurativa on or near affected area 3. Pregnancy or lactation 4. Known allergic reactions to components of Hidrawear AX
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin for which there are limited wound dressing products.
This is a study to assess the use HidraWear Ax vs current product and method of use, and to determine the impact on patients' quality of life.
Read the detailed description
The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's existing product use in 23 subjects with HS (Hidradenitis Suppurativa).
Secondary objectives are to evaluate if Hidrawear AX:
- Is comfortable
- Improves quality of life
- Faster to use than the subject's existing product
- Reduces dressing related pain
- Secure dressing retention
This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be assessed.
The clinical effect of the wound pad will not be assessed.
- Conditions
- Hidradenitis Suppurativa, Hidradenitis
- Being tested
- HidraWear Ax
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HidraWear AxDevice
An adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life assessment | Other | HidraWear AX Garment Receives: Device: HidraWear Ax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use Day 21 vs Day 0
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. self reported . A score of 0 means the product is very easy to use, and a score of 10 means the product is very difficult to use. A lower score represents a better outcome.
Measured: 3 weeks
Secondary outcomes (6)
Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a ten-item questionnaire designed to measure the impact of skin diseases on patients' quality of life, focusing on symptoms, daily activities, leisure, work or school, personal relationships, and treatment. It provides a quick and quantifiable assessment, with scores ranging from 0 (no impact) to 30 (extremely large impact), facilitating the evaluation of disease severity and treatment efficacy. A lower score represents a better outcome.
Measured: 3 weeks
Visual Pain Analogue Scale Day 21 vs Day 0
Patient reported pain, 10 point scale, high score indicates pain. 10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. self reported . A score of 0 means the patient experiences no pain, and a score of 10 means the patient experiences extreme pain. A lower score represents a better outcome.
Measured: 3 weeks
Time Taken to Dress Wounds
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. Self reported . A score of 0 means the product is very quick to use, and a score of 10 means the product is very time consuming to use. A lower score represents a better outcome.
Measured: 3 weeks
Body Image Visual Analogue Scale
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. Self reported . A score of 0 means the patient feels confident about their body image, and a score of 10 means the patient does not feel confident at all about their body image. A lower score represents a better outcome.
Measured: 3 weeks
Patient Comfort
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. Self reported . A score of 0 means the product is very comfortable to use and wear, and a score of 10 means the product is very uncomfortable to use and wear. A lower score represents a better outcome.
Measured: 3 weeks
Confidence in Dressing Product (Secure Retention, Leak Reduction)
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. Self reported . A score of 0 means the patient is confident in the products ability to remain in place and contain exudate, and a score of 10 indicates low confidence in products ability to remain in place or contain exudate. A lower score represents a better outcome.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start30 Oct 2019
- Primary completion3 Oct 2020
- Study completion3 Oct 2020
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HidraMed Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trevor Duffy, Principal investigator, Hermitage Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449354
- Sponsor's protocol ID
- CE-GAX-001-01 V4
- Status last verified
- Oct 2024
- First submitted
- 23 Jun 2020
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
- ClinicalTrials.gov ID
- NCT04449354
- Acronym / sponsor ID
- CE-GAX-001-01 V4
- Conditions
- Hidradenitis Suppurativa, Hidradenitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HidraMed Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 3 Oct 2020 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin for which there are limited wound dressing products.
This is a study to assess the use HidraWear Ax vs current product and method of use, and to determine the impact on patients' quality of life.
Detailed description
The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's existing product use in 23 subjects with HS (Hidradenitis Suppurativa).
Secondary objectives are to evaluate if Hidrawear AX:
- Is comfortable
- Improves quality of life
- Faster to use than the subject's existing product
- Reduces dressing related pain
- Secure dressing retention
This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be assessed.
The clinical effect of the wound pad will not be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life assessment | Other | Device: HidraWear AxHidraWear AX Garment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (1 listed)
- 1. Recent surgery <3 months in axilla 2. Psoriasis, Dermatitis or skin conditions/rash other than Hidradenitis Suppurativa on or near affected area 3. Pregnancy or lactation 4. Known allergic reactions to components of Hidrawear AX
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 |
|---|---|---|
| HidraWear AxAn adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place. | Device | Quality of Life assessment |
Primary outcome
Ease of Use Day 21 vs Day 0
Time frame: 3 weeks
10 point visual analogue scale with a maximum score of 10 and a minimum score of 0. self reported . A score of 0 means the product is very easy to use, and a score of 10 means the product is very difficult to use. A lower score represents a better outcome.
6 secondary outcomes
Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)
Time frame: 3 weeks
Visual Pain Analogue Scale Day 21 vs Day 0
Time frame: 3 weeks
Time Taken to Dress Wounds
Time frame: 3 weeks
Body Image Visual Analogue Scale
Time frame: 3 weeks
Patient Comfort
Time frame: 3 weeks
Confidence in Dressing Product (Secure Retention, Leak Reduction)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Trevor Duffy principal investigator
Hermitage Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HidraWear Ax in people with Hidradenitis Suppurativa and Hidradenitis, run by HidraMed Solutions Ltd at 1 site in Ireland.
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 7 inclusion and 1 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 21 Oct 2024. 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 Ireland. 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 21 Oct 2024). 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?
Ease of Use Day 21 vs Day 0 (time frame: 3 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 21 Oct 2024.