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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
ABWG is a hydro-gel applied topically using a tongue depressor
University of Miami
Miami, Florida, United States
Change in Microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
Time frame: Baseline, 4 weeks
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)
Time frame: Baseline, 4 week
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).
Time frame: 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.
Time frame: Baseline, 4 weeks
Change HS Lesion Erythema
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Time frame: Baseline, 4 weeks
Change in Exudate
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Time frame: Baseline, 4 weeks
Change in Range of Motion
As measured by goniometer
Time frame: Baseline, 4 weeks
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Number of Participants With Decreased Pain Medication Use
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
Time frame: 4 weeks
Number of Participants With Escalated Pain Medication Use
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
Time frame: 4 weeks
Change in Number of Days of Work/School Lost
As self-reported by participants the number of days missed over the length of the study.
Time frame: Baseline, 4 weeks
Number of Dressings Used
As reported by participants
Time frame: 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
Time frame: 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
Time frame: Baseline, 4 weeks