Hidradenitis Suppurativa (HS) Tunneling Wounds
- Conditions
- Hidradenitis Suppurativa
- Registration Number
- NCT04648631
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Microbiome Baseline, 4 weeks As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
- Secondary Outcome Measures
Name Time Method Change in Lesion Severity as Measured by HS-PGA Baseline, 4 week HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)
Change in Lesion Severity as Measured by the Hurley Stage 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).
Change in Pain as Measured by VAS Baseline, 4 weeks Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.
Change HS Lesion Erythema Baseline, 4 weeks As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Number of Participants With Decreased Pain Medication Use 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
Change in Number of Days of Work/School Lost Baseline, 4 weeks As self-reported by participants the number of days missed over the length of the study.
Number of Dressings Used 4 weeks As reported by participants
Change in Range of Motion Baseline, 4 weeks As measured by goniometer
Number of Participants With Escalated Pain Medication Use 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
Change in Exudate Baseline, 4 weeks Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Change in Quality of Life as Measured by HiSQOL 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
Change in Quality of Life as Measured by DLQI 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
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States
University of Miami🇺🇸Miami, Florida, United States