Hidradenitis Suppurativa (HS) Tunneling Wounds

Study Overview
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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.

Official Title
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The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Device: antibiofilm surfactant wound gel (ABWG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABWG<br>The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. | Device: antibiofilm surfactant wound gel (ABWG)<br>* ABWG is a hydro-gel applied topically using a tongue depressor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome | As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples. | Baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lesion severity as measured by HS-PGA | HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe) | Baseline, 4 weeks | 
| Change in lesion severity as measured by the Hurley Stage | 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). | Baseline, 4 weeks | 
| Change in pain as measured by VAS | Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain. | Baseline, 4 weeks | 
| Change HS lesion erythema | As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe). | Baseline, 4 weeks | 
| Change in exudate | Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). | Baseline, 4 weeks | 
| Change in range of motion | As measured by a goniometer | Baseline, 4 weeks | 
| Number of participants with decreased pain medication use | Change in 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 | 4 weeks | 
| Number of participants with escalated pain medication use | Change in 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 | 4 weeks | 
| Change in number of days of work/school lost | As reported by participants | Baseline, 4 weeks | 
| Number of dressings used | As reported by participants | 4 weeks | 
| Change in quality of life as measured by HiSQOL | 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 | Baseline, 4 weeks | 
| Change in quality of life as measured by DLQI | 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 | Baseline, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tunneling wound