search
Back to results

HidraWear AX HS Study

Primary Purpose

Hidradenitis Suppurativa, Hidradenitis

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
HidraWear Ax
Sponsored by
HidraMed Solutions Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Hermitage Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Quality of Life assessment

Arm Description

HidraWear AX Garment

Outcomes

Primary Outcome Measures

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.
Visual Pain Analogue Scale Day 21 vs Day 0
Patient reported pain, 10 point scale, high score indicates pain

Secondary Outcome Measures

Ease of Use Day 21 vs Day 0
10 point scale, self reported . High score indicates difficulty using product
Time taken to dress wounds
10 point scale, high score indicating product is time consuming to use
Body Image visual analogue scale
10 point scale, self reported, high score indicates poor body image

Full Information

First Posted
June 23, 2020
Last Updated
February 8, 2021
Sponsor
HidraMed Solutions Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04449354
Brief Title
HidraWear AX HS Study
Official Title
A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
October 3, 2020 (Actual)
Study Completion Date
October 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HidraMed Solutions Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Hidradenitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quality of Life assessment
Arm Type
Other
Arm Description
HidraWear AX Garment
Intervention Type
Device
Intervention Name(s)
HidraWear Ax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of Life (QoL) measured using the Dermatology Life Quality Index (DLQI)
Description
Questionnaire determining the impact of dermatological disease on patient's quality of life. Scored out of 30, high score indicates impairment.
Time Frame
3 weeks
Title
Visual Pain Analogue Scale Day 21 vs Day 0
Description
Patient reported pain, 10 point scale, high score indicates pain
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Ease of Use Day 21 vs Day 0
Description
10 point scale, self reported . High score indicates difficulty using product
Time Frame
3 weeks
Title
Time taken to dress wounds
Description
10 point scale, high score indicating product is time consuming to use
Time Frame
3 weeks
Title
Body Image visual analogue scale
Description
10 point scale, self reported, high score indicates poor body image
Time Frame
3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Product is designed for females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Duffy
Organizational Affiliation
Hermitage Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hermitage Clinic
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HidraWear AX HS Study

We'll reach out to this number within 24 hrs