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Completed

NCT Number: NCT04648631

Hidradenitis Suppurativa (HS) Tunneling Wounds

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.

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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

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

antibiofilm surfactant wound gel (ABWG)

Device

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

Primary outcomes

  1. Change in Microbiome

    Time frame: Baseline, 4 weeks

    As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.

Secondary outcomes

  1. Change in Lesion Severity as Measured by HS-PGA

    Time frame: Baseline, 4 week

    HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)

  2. Change in Lesion Severity as Measured by the Hurley Stage

    Time frame: Baseline, 4 weeks

    The Hurley score is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening normal skin).

  3. Change in Pain as Measured by VAS

    Time frame: Baseline, 4 weeks

    Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.

  4. Change HS Lesion Erythema

    Time frame: Baseline, 4 weeks

    As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).

  5. Change in Exudate

    Time frame: Baseline, 4 weeks

    Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).

  6. Change in Range of Motion

    Time frame: Baseline, 4 weeks

    As measured by goniometer

  7. Number of Participants With Decreased Pain Medication Use

    Time frame: 4 weeks

    Pain medication use will be reported as the number of participants that reports a decrease in the dose and/or frequency of pain medication use

  8. Number of Participants With Escalated Pain Medication Use

    Time frame: 4 weeks

    Pain medication use will be reported as the number of participants that reports an escalation from using Non-steroidal Anti-inflammatory Drugs (NSAIDs)/acetaminophen to opioids

  9. Change in Number of Days of Work/School Lost

    Time frame: Baseline, 4 weeks

    As self-reported by participants the number of days missed over the length of the study.

  10. Number of Dressings Used

    Time frame: 4 weeks

    As reported by participants

  11. Change in Quality of Life as Measured by HiSQOL

    Time frame: Baseline, 4 weeks

    HS quality of life (HiSQOL) has a total score ranging from 0 to 68, with higher scores indicating more severe impact on participant's quality of life

  12. Change in Quality of Life as Measured by DLQI

    Time frame: Baseline, 4 weeks

    Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Next Science LLC

Registry information

Official study title

The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2020
Registry last updated
Apr 2, 2024

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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