HidraWear Study for Hidradenitis Suppurativa Wounds

HidraMed Solutions

Status: Completed

Conditions: Hidradenitis; Hidradenitis Suppurativa

Treatments: Device: HidraWear Ax

Study type: Interventional

Funder types: Industry

Identifiers

NCT04449354

CE-GAX-001-01 V4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Quality of Life assessment

Other group

Description:

HidraWear AX Garment

Treatment:

Device: HidraWear Ax