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A Bioelectric Dressing for Post De-Roofing Treatment of HS

Primary Purpose

Hidradenitis Suppurativa

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procellera Bioelectric Dressing
Standard Gauze Dressing
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit

Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit

Arm Description

Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the right armpit and will receive the standard gauze dressing for up to 8 weeks on the left armpit.

Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the left armpit and will receive the standard gauze dressing for up to 8 weeks on the right armpit.

Outcomes

Primary Outcome Measures

Healing Rate
The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.

Secondary Outcome Measures

Average time to complete healing
The average time, measured in days, to complete healing as assessed by treating physician will be reported
Number of subjects with complete healing
The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.
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.
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.
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.
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)
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).
Shoulder range of motion
Shoulder range of motion will be measured using a goniometer
Number of dressings used through to healing day
The number of dressings used through to healing day will be reported
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.
Days of work lost
Participants reported days of work lost due to the procedure will be reported
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
Tissue analysis of microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples.

Full Information

First Posted
September 15, 2021
Last Updated
October 9, 2023
Sponsor
University of Miami
Collaborators
Vomaris Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT05057429
Brief Title
A Bioelectric Dressing for Post De-Roofing Treatment of HS
Official Title
A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Vomaris Innovations

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit
Arm Type
Experimental
Arm Description
Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the right armpit and will receive the standard gauze dressing for up to 8 weeks on the left armpit.
Arm Title
Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit
Arm Type
Experimental
Arm Description
Participants undergoing standard of care deroofing surgery will be randomized to receive the bioelectric dressing for up to 8 weeks on the left armpit and will receive the standard gauze dressing for up to 8 weeks on the right armpit.
Intervention Type
Device
Intervention Name(s)
Procellera Bioelectric Dressing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Gauze Dressing
Intervention Description
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Primary Outcome Measure Information:
Title
Healing Rate
Description
The healing rate of post-surgical wounds will be reported as the area reduction in cm^2/per day.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Average time to complete healing
Description
The average time, measured in days, to complete healing as assessed by treating physician will be reported
Time Frame
Up to 8 weeks
Title
Number of subjects with complete healing
Description
The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported.
Time Frame
Up to 8 weeks
Title
Number of subjects with nodule and/or tunnel recurrence
Description
The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported.
Time Frame
Up to 8 weeks
Title
Average pain as assessed by the Numerical Rating Scale (NRS)
Description
The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Time Frame
Up to 8 weeks
Title
Number of subjects with tenderness at surgical sites
Description
The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported.
Time Frame
Up to 8 weeks
Title
Quality of post-surgical scars as measured by the Hurley Stage score
Description
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)
Time Frame
Up to 8 weeks
Title
Amount of exudate at surgical site
Description
The amount of exudate at surgical site will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Time Frame
Up to 8 weeks
Title
Shoulder range of motion
Description
Shoulder range of motion will be measured using a goniometer
Time Frame
Up to 8 weeks
Title
Number of dressings used through to healing day
Description
The number of dressings used through to healing day will be reported
Time Frame
Up to 8 weeks
Title
Pain after procedure as assessed by the NRS
Description
The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
Time Frame
Day 2 (24 hours post procedure)
Title
Days of work lost
Description
Participants reported days of work lost due to the procedure will be reported
Time Frame
Up to 8 weeks
Title
Change in Quality of Life as measured by the DLQI
Description
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
Time Frame
Baseline, Up to 8 weeks
Title
Tissue analysis of microbiome
Description
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Bioelectric Dressing for Post De-Roofing Treatment of HS

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