Wound Dressings for Hidradenitis Suppurativa

NCT ID: NCT04194541

Last Updated: 2023-03-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2021-03-08

Brief Summary

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The primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).

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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Treatment Group

Participants will be provided a kit containing 3 dressings: Cutimed Sorbact Hydroactive B, Cutimed Siltec, and Sorbion Sana multi-star. Participant can use their dressing of choice and can change their dressings as needed for 6 consecutive weeks.

Group Type EXPERIMENTAL

Cutimed Sorbact Hydroactive B wound dressing

Intervention Type DEVICE

Wound dressing applied and changed as needed.

Cutimed Siltect wound dressing

Intervention Type DEVICE

Wound dressing applied and changed as needed.

Sorbion Sana multi-star wound dressing

Intervention Type DEVICE

Wound dressing applied and changed as needed.

Interventions

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Cutimed Sorbact Hydroactive B wound dressing

Wound dressing applied and changed as needed.

Intervention Type DEVICE

Cutimed Siltect wound dressing

Wound dressing applied and changed as needed.

Intervention Type DEVICE

Sorbion Sana multi-star wound dressing

Wound dressing applied and changed as needed.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥18 years of age
* Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
* Presence of at least one lesion with active drainage
* Willing and able to provide informed consent

Exclusion Criteria

* Subjects younger than 18-years-old.
* Prisoners
* Pregnant or lactating women
* Adults unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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 and Statistical Analysis Plan

View Document

Other Identifiers

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20191046

Identifier Type: -

Identifier Source: org_study_id

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