N/A
N=16
HidraWear Study for Hidradenitis Suppurativa Wounds
Hidradenitis Suppurativa · Hidradenitis
Bottom Line
View on ClinicalTrials.gov: NCT04449354 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Ease of Use Day 21 vs Day 0 — 6.47; 0.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HidraWear Ax (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- HidraMed Solutions Ltd
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Use Day 21 vs Day 0 |
6.47; 0.6 | — |
| SECONDARY Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI) |
19.3; 4.53 | — |
| SECONDARY Visual Pain Analogue Scale Day 21 vs Day 0 |
5.53; 0.80 | — |
| SECONDARY Time Taken to Dress Wounds |
6.93; 0.67 | — |
| SECONDARY Body Image Visual Analogue Scale |
8.53; 3.8 | — |
| SECONDARY Patient Comfort |
8.13; 1 | — |
| SECONDARY Confidence in Dressing Product (Secure Retention, Leak Reduction) |
8.4; 1.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04449354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.