HidraWear Study for Hidradenitis Suppurativa Wounds

NCT04449354 | Completed Results

• 1 other identifier: CE-GAX-001-01 V4
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa; Hidradenitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)

  3 weeks

• Visual Pain Analogue Scale Day 21 vs Day 0

  3 weeks

• Time Taken to Dress Wounds

  3 weeks

• Body Image Visual Analogue Scale

  3 weeks

• Patient Comfort

  3 weeks

Study Arms (1)

Quality of Life assessment

OTHER

HidraWear AX Garment

Device: HidraWear Ax

Interventions

HidraWear Ax DEVICE

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.

Quality of Life assessment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Product is designed for females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• HidraMed Solutions Ltd: lead

Study Sites (1)

The Hermitage Clinic

Dublin, Ireland

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Results Point of Contact

• Title: Suzanne Moloney
• Organization: HidraMed Solutions Ltd

suzanne@hidramedsolutions.com

+353873220509

Study Officials

• Trevor Duffy

  Hermitage Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: October 30, 2019
• Primary Completion: October 3, 2020
• Study Completion: October 3, 2020
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)