HidraWear Study for Hidradenitis Suppurativa Wounds

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa; Hidradenitis
• Intervention / Treatment: Device: HidraWear Ax

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • The Hermitage Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Quality of Life assessment; HidraWear AX Garment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	3 weeks

Collaborators and Investigators

• Sponsor: HidraMed Solutions Ltd
• Investigators: Principal Investigator: Trevor Duffy, Hermitage Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): October 3, 2020
• Study Completion (Actual): October 3, 2020

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CE-GAX-001-01 V4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No