A Bioelectric Dressing for Post De-Roofing Treatment of HS
NCT ID: NCT05057429
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2021-10-11
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing 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 right armpit and will receive the standard gauze dressing for up to 8 weeks on the left armpit.
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.
Standard Gauze Dressing
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right 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.
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.
Standard Gauze Dressing
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Interventions
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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.
Standard Gauze Dressing
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vomaris Innovations
INDUSTRY
University of Miami
OTHER
Responsible Party
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Hadar Lev-Tov
Assistant Professor of Clinical
Principal Investigators
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Hadar Lev-Tov, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20210621
Identifier Type: -
Identifier Source: org_study_id
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