Hidradenitis, Hidradenitis Suppurativa
Conditions
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.
Interventions
DEVICEHidraWear Ax
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.
Sponsors
HidraMed Solutions Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use Day 21 vs Day 0 | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Pain Analogue Scale Day 21 vs Day 0 | 3 weeks | Patient reported pain, 10 point scale, high score indicates pain. 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 patient experiences no pain, and a score of 10 means the patient experiences extreme pain. A lower score represents a better outcome. |
| Time Taken to Dress Wounds | 3 weeks | 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 quick to use, and a score of 10 means the product is very time consuming to use. A lower score represents a better outcome. |
| Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI) | 3 weeks | The Dermatology Life Quality Index (DLQI) is a ten-item questionnaire designed to measure the impact of skin diseases on patients' quality of life, focusing on symptoms, daily activities, leisure, work or school, personal relationships, and treatment. It provides a quick and quantifiable assessment, with scores ranging from 0 (no impact) to 30 (extremely large impact), facilitating the evaluation of disease severity and treatment efficacy. A lower score represents a better outcome. |
| Patient Comfort | 3 weeks | 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 comfortable to use and wear, and a score of 10 means the product is very uncomfortable to use and wear. A lower score represents a better outcome. |
| Confidence in Dressing Product (Secure Retention, Leak Reduction) | 3 weeks | 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 patient is confident in the products ability to remain in place and contain exudate, and a score of 10 indicates low confidence in products ability to remain in place or contain exudate. A lower score represents a better outcome. |
| Body Image Visual Analogue Scale | 3 weeks | 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 patient feels confident about their body image, and a score of 10 means the patient does not feel confident at all about their body image. A lower score represents a better outcome. |
Countries
Ireland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HidraWear AX HidraWear AX Garment
HidraWear Ax: 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 panel 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.
Participants used HidraWear AX for 21 days | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HidraWear AX | — |
|---|---|---|
| Age, Categorical <=18 years | 16 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Ireland | 16 Participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Ease of Use Day 21 vs Day 0 | Day 0 | 6.47 score on a scale | Standard Deviation 2.75 |
| HidraWear AX | Ease of Use Day 21 vs Day 0 | Day 21 | 0.6 score on a scale | Standard Deviation 1.59 |
Secondary
Body Image Visual Analogue Scale
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 patient feels confident about their body image, and a score of 10 means the patient does not feel confident at all about their body image. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Body Image Visual Analogue Scale | Day 21 | 3.8 score on a scale | Standard Deviation 2.18 |
| HidraWear AX | Body Image Visual Analogue Scale | Day 0 | 8.53 score on a scale | Standard Deviation 1.92 |
Secondary
Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a ten-item questionnaire designed to measure the impact of skin diseases on patients' quality of life, focusing on symptoms, daily activities, leisure, work or school, personal relationships, and treatment. It provides a quick and quantifiable assessment, with scores ranging from 0 (no impact) to 30 (extremely large impact), facilitating the evaluation of disease severity and treatment efficacy. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI) | Day 0 | 19.3 score in the DLQI Questionnaire | Standard Deviation 5.73 |
| HidraWear AX | Change in Quality of Life (QoL) Measured Using the Dermatology Life Quality Index (DLQI) | Day 21 | 4.53 score in the DLQI Questionnaire | Standard Deviation 3.93 |
Secondary
Confidence in Dressing Product (Secure Retention, Leak Reduction)
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 patient is confident in the products ability to remain in place and contain exudate, and a score of 10 indicates low confidence in products ability to remain in place or contain exudate. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Confidence in Dressing Product (Secure Retention, Leak Reduction) | Day 0 | 8.4 score on a scale | Standard Deviation 2.53 |
| HidraWear AX | Confidence in Dressing Product (Secure Retention, Leak Reduction) | Day 21 | 1.2 score on a scale | Standard Deviation 1.82 |
Secondary
Patient Comfort
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 comfortable to use and wear, and a score of 10 means the product is very uncomfortable to use and wear. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Patient Comfort | Day 0 | 8.13 score on a scale | Standard Deviation 1.92 |
| HidraWear AX | Patient Comfort | Day 21 | 1 score on a scale | Standard Deviation 1.25 |
Secondary
Time Taken to Dress Wounds
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 quick to use, and a score of 10 means the product is very time consuming to use. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Time Taken to Dress Wounds | Day 0 | 6.93 score on a scale | Standard Deviation 2.46 |
| HidraWear AX | Time Taken to Dress Wounds | Day 21 | 0.67 score on a scale | Standard Deviation 1.4 |
Secondary
Visual Pain Analogue Scale Day 21 vs Day 0
Patient reported pain, 10 point scale, high score indicates pain. 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 patient experiences no pain, and a score of 10 means the patient experiences extreme pain. A lower score represents a better outcome.
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HidraWear AX | Visual Pain Analogue Scale Day 21 vs Day 0 | Day 0 | 5.53 score on a scale | Standard Deviation 2.5 |
| HidraWear AX | Visual Pain Analogue Scale Day 21 vs Day 0 | Day 21 | 0.80 score on a scale | Standard Deviation 1.67 |