What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include antibiotics, hormonal therapy, and surgical interventions. Antibiotics can cause gastrointestinal upset and antibiotic resistance. Hormonal therapies, such as oral contraceptives and spironolactone, may lead to menstrual irregularities, breast tenderness, and an increased risk of blood clots. Surgical treatments, including de-roofing and excision, carry risks of infection, scarring, and recurrence of lesions. Emerging treatments like bioelectric dressings aim to promote cell growth and tissue repair with potentially fewer side effects, but more research is needed to confirm their safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, including biologic TNF-alpha inhibitors such as adalimumab (Humira), which is specifically indicated for moderate to severe HS. While there are no FDA-approved treatments that directly involve electrical stimulation like the bioelectric dressing being studied, the focus on innovative therapies highlights the ongoing efforts to improve wound healing and tissue repair in HS patients. Other treatments for HS often include antibiotics, hormonal therapy, and surgical interventions.

What other types of research exist?

Promising novel alternatives to Bioelectric Dressing for Hidradenitis Suppurativa patients include: 1) Electrochemical Therapy: This involves using needle electrodes to create localized pH-driven electrochemical reactions, which have shown potential in modifying tissue properties and promoting healing. 2) Electrical Stimulation (ES): Direct current ES has been shown to enhance fibroblast growth and cytokine secretion, which are crucial for wound healing. 3) Protein Replacement Therapy: This involves delivering recombinant collagen type VII to skin wounds, which has shown promise in preclinical studies for improving tissue repair. These alternatives offer innovative approaches to enhance wound healing and tissue repair in HS patients.

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Bioelectric Dressing

Bioelectric Dressing for Hidradenitis Suppurativa

N/A

Waitlist Available

Led By Hadar Lev-Tov, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have diagnosis of HS confirmed by a dermatologist

Be older than 18 years old

Must not have

Individuals who are not yet adults

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 (24 hours post procedure)

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions related to the bioelectric dressing material. Standard gauze could cause discomfort or infection if not changed properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My HS diagnosis was confirmed by a dermatologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under the age of 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 (24 hours post procedure)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 (24 hours post procedure)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 (24 hours post procedure) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Healing Rate

Secondary study objectives

Amount of exudate at surgical site

Average pain as assessed by the Numerical Rating Scale (NRS)

Average time to complete healing

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Hidradenitis Suppurativa (HS) include antibiotics, hormonal therapy, and surgical interventions. Antibiotics reduce bacterial load and inflammation, while hormonal therapies address underlying hormonal imbalances that can exacerbate HS. Surgical options, such as de-roofing, remove affected tissue to promote healing. The bioelectric dressing, which uses electrical stimulation to promote cell growth and tissue repair, represents a novel approach by enhancing the body's natural healing processes. This is particularly important for HS patients, as it may offer improved healing outcomes and reduce the recurrence of lesions, thereby improving quality of life.