HidraWear AX HS Study
Primary Purpose
Hidradenitis Suppurativa, Hidradenitis
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
HidraWear Ax
Sponsored by
About this trial
This is an interventional supportive care trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- The Hermitage Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Quality of Life assessment
Arm Description
HidraWear AX Garment
Outcomes
Primary Outcome Measures
Change in Quality of Life (QoL) measured using the Dermatology Life Quality Index (DLQI)
Questionnaire determining the impact of dermatological disease on patient's quality of life. Scored out of 30, high score indicates impairment.
Visual Pain Analogue Scale Day 21 vs Day 0
Patient reported pain, 10 point scale, high score indicates pain
Secondary Outcome Measures
Ease of Use Day 21 vs Day 0
10 point scale, self reported . High score indicates difficulty using product
Time taken to dress wounds
10 point scale, high score indicating product is time consuming to use
Body Image visual analogue scale
10 point scale, self reported, high score indicates poor body image
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04449354
Brief Title
HidraWear AX HS Study
Official Title
A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
October 3, 2020 (Actual)
Study Completion Date
October 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HidraMed Solutions Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Hidradenitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quality of Life assessment
Arm Type
Other
Arm Description
HidraWear AX Garment
Intervention Type
Device
Intervention Name(s)
HidraWear Ax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of Life (QoL) measured using the Dermatology Life Quality Index (DLQI)
Description
Questionnaire determining the impact of dermatological disease on patient's quality of life. Scored out of 30, high score indicates impairment.
Time Frame
3 weeks
Title
Visual Pain Analogue Scale Day 21 vs Day 0
Description
Patient reported pain, 10 point scale, high score indicates pain
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Ease of Use Day 21 vs Day 0
Description
10 point scale, self reported . High score indicates difficulty using product
Time Frame
3 weeks
Title
Time taken to dress wounds
Description
10 point scale, high score indicating product is time consuming to use
Time Frame
3 weeks
Title
Body Image visual analogue scale
Description
10 point scale, self reported, high score indicates poor body image
Time Frame
3 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Product is designed for females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Duffy
Organizational Affiliation
Hermitage Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hermitage Clinic
City
Dublin
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
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HidraWear AX HS Study
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