HidraWear Study for Hidradenitis Suppurativa Wounds

Not Applicable

Completed

Conditions: Hidradenitis
Hidradenitis Suppurativa

Interventions: Device: HidraWear Ax

Registration Number: NCT04449354

Lead Sponsor: HidraMed Solutions Ltd

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 16

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision of signed and dated informed consent form in English.
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, aged >18
4. Diagnosed with Hidradenitis Suppurativa
5. Hidradenitis Suppurativa affecting the axilla
6. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quality of Life assessment	HidraWear Ax	HidraWear AX Garment

Primary Outcome Measures

Name	Time	Method
Ease of Use Day 21 vs Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)	3 weeks	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.
Visual Pain Analogue Scale Day 21 vs Day 0	3 weeks	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.
Time Taken to Dress Wounds	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 quick to use, and a score of 10 means the product is very time consuming to use. A lower score represents a better outcome.
Body Image Visual Analogue Scale	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 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.
Patient Comfort	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 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.
Confidence in Dressing Product (Secure Retention, Leak Reduction)	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 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.