HidraWear AX HS Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting

Conditions
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Hidradenitis Suppurativa, Hidradenitis

Intervention / Treatment
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* Device: HidraWear Ax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quality of Life assessment<br>HidraWear AX Garment | Device: HidraWear Ax<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 
| Visual Pain Analogue Scale Day 21 vs Day 0 | Patient reported pain, 10 point scale, high score indicates pain | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use Day 21 vs Day 0 | 10 point scale, self reported . High score indicates difficulty using product | 3 weeks | 
| Time taken to dress wounds | 10 point scale, high score indicating product is time consuming to use | 3 weeks | 
| Body Image visual analogue scale | 10 point scale, self reported, high score indicates poor body image | 3 weeks |