Hidradenitis Suppurativa (HS) Tunneling Wounds

NCT ID: NCT04648631

Last Updated: 2024-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2022-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABWG

The participants in this group will be receiving the ABWG daily for 4 consecutive weeks.

Group Type EXPERIMENTAL

antibiofilm surfactant wound gel (ABWG)

Intervention Type DEVICE

ABWG is a hydro-gel applied topically using a tongue depressor

Interventions

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antibiofilm surfactant wound gel (ABWG)

ABWG is a hydro-gel applied topically using a tongue depressor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults 18 years old and older
2. Have diagnosis of HS confirmed by a dermatologist
3. Have at least one HS related tunneling wound that is at least 2 centimeters in length
4. Able to provide informed consent

Exclusion Criteria

1. Individuals who are not yet adults
2. Women known to be pregnant
3. Prisoners
4. Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Next Science LLC

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Hadar Lev-Tov

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hadar Lev-Tov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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20201035

Identifier Type: -

Identifier Source: org_study_id

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