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Completed

NCT Number: NCT04194541

Wound Dressings for Hidradenitis Suppurativa

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).

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutimed Sorbact Hydroactive B wound dressing

Device

Wound dressing applied and changed as needed.

Cutimed Siltect wound dressing

Device

Wound dressing applied and changed as needed.

Sorbion Sana multi-star wound dressing

Device

Wound dressing applied and changed as needed.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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