Wound Dressings for Hidradenitis Suppurativa

March 10, 2023 updated by: Hadar Lev-Tov, University of Miami
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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Wound dressing applied and changed as needed.
Wound dressing applied and changed as needed.
Wound dressing applied and changed as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology Life Quality Index (DLQI) Scores
Time Frame: At Baseline, at 6 Weeks
Participant quality of life as measured via DLQI. DLQI has a total score ranging from 0-30 with the higher score indicating more impairment on the participant's quality of life.
At Baseline, at 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Pain as Assessed by the Numerical Rating Scale (NRS)
Time Frame: At Baseline, at 6 Weeks
The average pain reported over the last 24 hours will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
At Baseline, at 6 Weeks
Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
Time Frame: At Baseline, at 6 Weeks
The pain rating at its worse over the last 24 hours will be reported as the maximal pain using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
At Baseline, at 6 Weeks
Sleep Rating
Time Frame: At Baseline, at 6 Weeks
Sleep rating will be evaluated using a 5 point Likert scale ranging from 1-5 with the higher score indicating increased sleep disturbance.
At Baseline, at 6 Weeks
Drainage Rating
Time Frame: At Baseline, at 6 Weeks
Lesion drainage rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion draining. For participants with multiple wounds/lesions, the drainage rating will be a comprehensive assessment of all wounds/lesions.
At Baseline, at 6 Weeks
Odor Rating
Time Frame: At Baseline, at 6 Weeks
Lesion odor rating will be evaluated using a 4 point Likert scale ranging from 1-4 with the higher score indicating increased lesion odor. For participants with multiple wounds/lesions, the odor rating will be a comprehensive assessment of all wounds/lesions.
At Baseline, at 6 Weeks
Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
Time Frame: At 6 Weeks
HS-PGA Scale scores patient disease severity as one of the following: clear, minimal, mild, moderate, severe, and very severe. The number of participants scored at each scale will be reported.
At 6 Weeks
Average Frequency of Dressing Changes
Time Frame: 6 Weeks
Participant reported frequency of dressing changes per wound per day. For participants with multiple wounds/lesions, the frequency of dressing changes will be a comprehensive assessment of all wounds/lesions.
6 Weeks
Number of Participants Reporting Overall Dressing Preference for Specific Body Part
Time Frame: At Baseline
Overall dressing preference will be reported as the number of participants preferring to use a particular wound dressing in the kit provided.
At Baseline
Number of Participants Reporting Dressing Preference for Each Specific Body Part
Time Frame: Visit 1 (Day 14)
Participant reported dressing preference for specific body parts for each of the interventions received.
Visit 1 (Day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2020

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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