Trial Outcomes & Findings for HidraWear Study for Hidradenitis Suppurativa Wounds (NCT NCT04449354)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

3 weeks

Results posted on

2024-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HidraWear AX n=16 Participants 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
Age, Categorical <=18 years	16 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants
Sex: Female, Male Female	16 Participants n=16 Participants
Sex: Female, Male Male	0 Participants n=16 Participants
Region of Enrollment Ireland	16 Participants n=16 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Ease of Use Day 21 vs Day 0 Day 21	0.6 score on a scale Standard Deviation 1.59
Ease of Use Day 21 vs Day 0 Day 0	6.47 score on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Visual Pain Analogue Scale Day 21 vs Day 0 Day 0	5.53 score on a scale Standard Deviation 2.50
Visual Pain Analogue Scale Day 21 vs Day 0 Day 21	0.80 score on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Time Taken to Dress Wounds Day 0	6.93 score on a scale Standard Deviation 2.46
Time Taken to Dress Wounds Day 21	0.67 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Body Image Visual Analogue Scale Day 0	8.53 score on a scale Standard Deviation 1.92
Body Image Visual Analogue Scale Day 21	3.8 score on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Patient Comfort Day 0	8.13 score on a scale Standard Deviation 1.92
Patient Comfort Day 21	1 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HidraWear AX n=15 Participants 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
Confidence in Dressing Product (Secure Retention, Leak Reduction) Day 0	8.4 score on a scale Standard Deviation 2.53
Confidence in Dressing Product (Secure Retention, Leak Reduction) Day 21	1.2 score on a scale Standard Deviation 1.82

Adverse Events

HidraWear AX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Moloney

HidraMed Solutions Ltd

Phone: +353873220509

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place