Bioelectric Dressing for Hidradenitis Suppurativa

Overseen By Maria Muniz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Prisoners, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of bandage, called a bioelectric dressing, improves wound healing after surgery for hidradenitis suppurativa (HS), a skin condition that causes painful lumps. Participants will receive the Procellera Bioelectric Dressing on one armpit and a regular gauze dressing on the other. The goal is to determine which dressing promotes faster and better healing after the procedure. This trial suits adults diagnosed with HS who have at least two problem areas needing treatment. As an unphased trial, it offers participants the opportunity to contribute to innovative wound care research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this bioelectric dressing is safe for use in surgical healing?

Research shows that the Procellera Bioelectric Dressing is generally safe for use. One study found that patients using this dressing experienced an 88% reduction in wound size after three weeks. This indicates that the dressing aids in wound healing without causing major side effects. While detailed information on side effects is limited in these studies, the dressing's significant reduction in wound size suggests its safety. Major safety issues would likely prevent such positive healing outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Procellera Bioelectric Dressing for treating hidradenitis suppurativa because it introduces a novel approach using bioelectric technology to promote healing. Unlike standard treatments, which typically involve antibiotics, surgery, and conventional dressings, this bioelectric dressing generates electrical fields designed to enhance wound healing and reduce inflammation directly at the site. This innovative mechanism could offer faster healing times and better management of symptoms compared to traditional methods, providing a much-needed advancement in the care of this chronic skin condition.

What evidence suggests that the Procellera Bioelectric Dressing might be an effective treatment for Hidradenitis Suppurativa?

Research has shown that Procellera Bioelectric Dressing might help wounds heal faster. Some studies have found that wounds treated with this dressing heal quicker and require fewer changes, potentially saving money. The dressing uses V.Dox Technology, which may accelerate healing and reduce signs of infection. In one study, all patients showed improvement, and one patient's wound completely healed after six treatments. In this trial, participants will receive the bioelectric dressing on one armpit and a standard gauze dressing on the other to compare their effectiveness. While the results are promising, more research is needed to confirm its benefits for hidradenitis suppurativa specifically. ^{1 2 5 6 7}

Who Is on the Research Team?

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Hidradenitis Suppurativa (HS) confirmed by a dermatologist. Participants must have at least two tunnels in different body areas and be able to consent. It's not for those allergic to the dressings, pregnant women, prisoners, or anyone who can't follow treatment application.

Inclusion Criteria

You need to have at least two additional pathways in different parts of your body.

My HS diagnosis was confirmed by a dermatologist.

Able to provide informed consent

Exclusion Criteria

Women known to be pregnant

Subject is allergic to any of the materials and dressings involved in the procedures

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard of care de-roofing surgery and receive either a bioelectric dressing or standard gauze dressing for up to 8 weeks

8 weeks

Weekly visits for dressing changes and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including healing rate and recurrence of nodules or tunnels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Procellera Bioelectric Dressing

Trial Overview

The study is examining if a bioelectric dressing aids healing post-de-roofing surgery compared to standard gauze dressing. De-roofing is a surgical procedure used in HS treatment.

How Is the Trial Designed?

Group I: Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit Experimental Treatment 2 Interventions

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.

Group II: Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Vomaris Innovations

Industry Sponsor

Trials

6

Recruited

130+

Published Research Related to This Trial

Bioelectric dressings were effective in promoting healing in hard-to-heal wounds, as demonstrated in a case report involving five patients, four with diabetic foot ulcers and one with a surgical site infection.

Out of the five wounds treated, one healed completely, while the others showed significant size reduction and improved tissue regeneration, indicating the potential of bioelectric dressings in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bioelectric dressings for patients with hard-to-heal wounds: a case report. Nair, HK., Yan, TD.[2023]

A microcell battery-impregnated bioelectric dressing (BED) was used on 5 small animal patients with complex wounds, and all wounds achieved complete closure within 4 weeks without infection or the need for grafting.

The BED not only supports wound healing but also provides a nonantibiotic antimicrobial effect, suggesting it could be a valuable tool in veterinary wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioelectric Dressing Supports Complex Wound Healing in Small Animal Patients. Maijer, A., Gessner, A., Trumpatori, B., et al.[2018]

Procellera is a novel wound care device that generates a microelectric potential (0.5-0.9 Volts) using a matrix of silver and zinc, which enhances wound healing without needing an external power source.

The device has shown efficacy against both planktonic and biofilm forms of wound pathogens, including multidrug-resistant organisms, making it a promising option for controlling infections in clinical and field settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. Kim, H., Park, S., Housler, G., et al.[2018]

In a study involving 80 US Army Ranger recruits, the bioelectric dressing Procellera® did not show a significant improvement in the healing rate of blisters compared to standard-of-care treatments like moleskin and Tegaderm® over a 2-week period.

Both treatment groups experienced low pain levels, indicating that the blisters were mild, and there was no statistical difference in pain between the Procellera and standard treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits. Housler, GJ., Cross, S., Marcel, V., et al.[2022]

The study evaluated the antibiofilm properties of a silver and zinc bioelectric dressing (Procellera) using a custom poloxamer biofilm model, showing significant inhibition of bacterial growth in nine pathogens, with reductions of approximately 2- to 3-fold log10 compared to controls.

The bioelectric dressing demonstrated effective antibiofilm activity against both single and polymicrobial biofilms, indicating its potential as a treatment for chronic infections that are difficult to manage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. Kim, H., Izadjoo, MJ.[2019]

Citations

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vomaris.com

vomaris.com/vomaris-announces-first-patient-enrollment-in-study-on-effects-of-bioelectric-wound-care-in-hidradenitis-suppurativa/

Vomaris Announces First Patient Enrollment in Study on ...

This randomized study aims to determine if Vomaris's bioelectric wound dressings, powered by V. Dox Technology, can improve healing rate and reduce signs of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10366058/

Emerging Treatments and the Clinical Trial Landscape for ...

[7] At 30 weeks, 70% of patients treated with the Alexandrite laser achieved hidradenitis suppurativa clinical response (HiSCR), compared to 20% ...

3.

link.springer.com

link.springer.com/article/10.1007/s13555-023-00957-5

Procedural and Wound Care Therapies

All eight patients reported improvement, with one patient demonstrating complete improvement after six treatments. However, the treatment did ...

4.

vomaris.com

vomaris.com/press-releases/

Press Releases

Vomaris Innovations, Inc. announced today the publication of results confirming that the company's bioelectric V.Dox™ Technology was effective in preventing and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10654645/

A Prospective, Randomized, Controlled Study to Evaluate ...

Two studies studied impact on rate of healing and showed that Procellera-treated wounds generally heal faster requiring fewer dressing changes and lowering cost ...

6.

clinicaltrial.be

clinicaltrial.be/en/details/38811?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

A Bioelectric Dressing for Post De-Roofing Treatment of H...

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- ...

7.

dermatologytimes.com

dermatologytimes.com/view/bioelectric-dressing-treats-acute-and-chronic-wounds

Bioelectric dressing treats acute and chronic wounds

At three weeks, investigators observed an 88 percent decrease in wound size for patients treated with Procellera, a 74 percent reduction in ...