12 Participants Needed

Bioelectric Dressing for Hidradenitis Suppurativa

MM
Overseen ByMaria Muniz
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Procellera Bioelectric Dressing for Hidradenitis Suppurativa?

Research shows that Procellera Bioelectric Dressing, which uses silver and zinc to create a small electric current, has been effective in managing infections and promoting healing in hard-to-heal wounds, such as diabetic foot ulcers and surgical site infections. Additionally, it has shown antibiofilm properties, which can help in treating chronic infections.12345

How does the Procellera Bioelectric Dressing treatment differ from other treatments for Hidradenitis Suppurativa?

The Procellera Bioelectric Dressing is unique because it generates a small electric current without needing an external power source, which can help promote wound healing and fight infection. This is different from traditional treatments that do not use electrical stimulation to enhance healing.13467

What is the purpose of this trial?

This trial is testing if a special bandage that uses tiny electrical signals can help patients heal faster after a specific type of surgery.

Research Team

Dr. Hadar Avihai Lev-Tov, MD - Miami ...

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

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
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left ArmpitExperimental Treatment2 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 ArmpitExperimental Treatment2 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Vomaris Innovations

Industry Sponsor

Trials
6
Recruited
130+

Findings from Research

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

References

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. [2018]
A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits. [2022]
Use of bioelectric dressings for patients with hard-to-heal wounds: a case report. [2023]
Efficacy of a bio-electric dressing in healing deep, partial-thickness wounds using a porcine model . [2012]
Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. [2019]
Bioelectric Dressing Supports Complex Wound Healing in Small Animal Patients. [2018]
Healing an intractable wound using bio-electrical stimulation therapy. [2005]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security