HidraWear AX HS Study

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449354
• Other study ID #: CE-GAX-001-01 V4
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: October 3, 2020

Study information

• Verified date: February 2021
• Source: HidraMed Solutions Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 3, 2020
• Est. primary completion date: October 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Device:
• HidraWear Ax
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.

Locations

Country	Name	City	State
Ireland	The Hermitage Clinic	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
HidraMed Solutions Ltd

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual Pain Analogue Scale Day 21 vs Day 0	Patient reported pain, 10 point scale, high score indicates pain	3 weeks
Secondary	Ease of Use Day 21 vs Day 0	10 point scale, self reported . High score indicates difficulty using product	3 weeks
Secondary	Time taken to dress wounds	10 point scale, high score indicating product is time consuming to use	3 weeks
Secondary	Body Image visual analogue scale	10 point scale, self reported, high score indicates poor body image	3 weeks