A Bioelectric Dressing for Post De-Roofing Treatment of HS

Hidradenitis Suppurativa Clinical Trial

Official title:

A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05057429
• Other study ID #: 20210621
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 years old and older.
• Have diagnosis of HS confirmed by a dermatologist
• Have at least two ancillary tunnels in separate anatomical sites
• Able to provide informed consent

Exclusion Criteria:

• Individuals who are not yet adults
• Subject is allergic to any of the materials and dressings involved in the procedures
• Women known to be pregnant
• Prisoners
• Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Device:
• Procellera Bioelectric Dressing
Procellera is single layer, broad-spectrum antimicrobial wound dressing. Embedded in the dressing are microcell batteries made of elemental silver and zinc applied in a dot-matrix pattern. The bioelectric dressing will be applied to surgical site wound with a hydrogel.

Other:
• Standard Gauze Dressing
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Vomaris Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Rate	The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.	Up to 8 weeks
Secondary	Average time to complete healing	The average time, measured in days, to complete healing as assessed by treating physician will be reported	Up to 8 weeks
Secondary	Number of subjects with complete healing	The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.	Up to 8 weeks
Secondary	Number of subjects with nodule and/or tunnel recurrence	The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.	Up to 8 weeks
Secondary	Average pain as assessed by the Numerical Rating Scale (NRS)	The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.	Up to 8 weeks
Secondary	Number of subjects with tenderness at surgical sites	The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.	Up to 8 weeks
Secondary	Quality of post-surgical scars as measured by the Hurley Stage score	The Hurley score is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening normal skin)	Up to 8 weeks
Secondary	Amount of exudate at surgical site	The amount of exudate at surgical site will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).	Up to 8 weeks
Secondary	Shoulder range of motion	Shoulder range of motion will be measured using a goniometer	Up to 8 weeks
Secondary	Number of dressings used through to healing day	The number of dressings used through to healing day will be reported	Up to 8 weeks
Secondary	Pain after procedure as assessed by the NRS	The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.	Day 2 (24 hours post procedure)
Secondary	Days of work lost	Participants reported days of work lost due to the procedure will be reported	Up to 8 weeks
Secondary	Change in Quality of Life as measured by the DLQI	Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life	Baseline, Up to 8 weeks
Secondary	Tissue analysis of microbiome	As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples.	Up to 8 weeks