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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
Adults 18 years old and older
Have diagnosis of HS confirmed by a dermatologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2 (24 hours post procedure)
Awards & highlights
Study Summary
This trial will test if a bioelectric dressing can help heal a surgical wound better than the standard treatment.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My HS diagnosis was confirmed by a dermatologist.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Healing Rate
Secondary outcome measures
Amount of exudate at surgical site
Average pain as assessed by the Numerical Rating Scale (NRS)
Average time to complete healing
+10 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
897 Previous Clinical Trials
409,248 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
123 Patients Enrolled for Hidradenitis Suppurativa
Vomaris InnovationsIndustry Sponsor
5 Previous Clinical Trials
118 Total Patients Enrolled
Hadar Lev-Tov, MDPrincipal InvestigatorUniversity of Miami
8 Previous Clinical Trials
218 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
123 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under the age of 18.I am 18 years old or older.You need to have at least two additional pathways in different parts of your body.My HS diagnosis was confirmed by a dermatologist.
Research Study Groups:
This trial has the following groups:- Group 1: Bioelectric Dressing on the Right Armpit and Standard Gauze Dressing on the Left Armpit
- Group 2: Bioelectric Dressing on the Left Armpit and Standard Gauze Dressing on the Right Armpit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being examined in this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this research study is actively seeking volunteers, with the initial posting made on October 11th 2021 and most recent update being September 7th 2022. 12 participants need to be recruited at a single site for successful completion of the trial."
Answered by AI
Is this investigation accepting new participants?
"Affirmative, the details on clinicaltrials.gov verify that this research project is actively recruiting participants. First disclosed on October 11th 2021, it has since been updated in September 2022 and requires 12 volunteers from a single study site."
Answered by AI
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