NCT04449354

HidraWear Study for Hidradenitis Suppurativa Wounds

A Study to Evaluate the HS Specific Wound Dressing HidraWear AX in the Home Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: HidraMed Solutions Ltd · Industry
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa
• Hidradenitis

Interventions

Type	Name	Description
DEVICE	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 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.

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-10-03
• Completion: 2020-10-03
• First posted: 2020-06-26
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

1 site across 1 country: Ireland