HidraWear AX HS Study

  • STATUS
    Recruiting
  • participants needed
    23
  • sponsor
    HidraMed Solutions Ltd
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Updated on 19 February 2024
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hidradenitis

Summary

The product, HidraWear AX 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.

Details
Condition Hidradenitis Suppurativa, Hidradenitis
Age 18years - 99years
Treatment HidraWear Ax
Clinical Study IdentifierNCT04449354
SponsorHidraMed Solutions Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'In order to be eligible to participate in this study, an individual must meet all of'
b'the following criteria:'
b'Provision of signed and dated informed consent form in English.'
b'Stated willingness to comply with all study procedures and availability for the'
b'duration of the study'
b'Female, aged >18'
b'Diagnosed with Hidradenitis Suppurativa'
b'Hidradenitis Suppurativa affecting the axilla'
b'Exuding lesion that requires wound dressings'

Exclusion Criteria

b'Recent surgery <3 months in axilla 2. Psoriasis, Dermatitis or skin conditions/rash'
b'other than Hidradenitis Suppurativa on or near affected area 3. Pregnancy or lactation'
b'Known allergic reactions to components of Hidrawear AX'
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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