Hidradenitis Suppurativa (HS) Tunneling Wounds
The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 1, 2020
CompletedStudy Start
First participant enrolled
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2022
CompletedResults Posted
Study results publicly available
April 2, 2024
CompletedApril 2, 2024
March 1, 2024
1.4 years
November 23, 2020
January 31, 2024
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
Baseline, 4 weeks
Secondary Outcomes (12)
Change in Lesion Severity as Measured by HS-PGA
Baseline, 4 week
Change in Lesion Severity as Measured by the Hurley Stage
Baseline, 4 weeks
Change in Pain as Measured by VAS
Baseline, 4 weeks
Change HS Lesion Erythema
Baseline, 4 weeks
Change in Exudate
Baseline, 4 weeks
- +7 more secondary outcomes
Study Arms (1)
ABWG
EXPERIMENTALThe participants in this group will be receiving the ABWG daily for 4 consecutive weeks.
Interventions
ABWG is a hydro-gel applied topically using a tongue depressor
Eligibility Criteria
You may qualify if:
- Adults 18 years old and older
- Have diagnosis of HS confirmed by a dermatologist
- Have at least one HS related tunneling wound that is at least 2 centimeters in length
- Able to provide informed consent
You may not qualify if:
- Individuals who are not yet adults
- Women known to be pregnant
- Prisoners
- Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Next Science LLCcollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hadar Lev-Tov, MD
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Hadar Lev-Tov, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 1, 2020
Study Start
February 26, 2021
Primary Completion
July 28, 2022
Study Completion
July 28, 2022
Last Updated
April 2, 2024
Results First Posted
April 2, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share