An interventional study of antibiofilm surfactant wound gel (ABWG) in Hidradenitis Suppurativa, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants in this group will be receiving the ABWG daily for 4 consecutive weeks.
Device: antibiofilm surfactant wound gel (ABWG)
ABWG is a hydro-gel applied topically using a tongue depressor
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
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
| Milestone | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
| colony forming units per ml (CFU/ml) | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 5.46 ± 1.85 |
| 4 weeks | 3.88 ± 1.09 |
HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)
| units on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 3.00 (2.00 to 5.00) |
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).
| score on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 2.00 (2.00 to 3.00) |
Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.
| units on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 1.40 (0.34 to 2.64) |
| 4 weeks | 0.96 (0.05 to 3.56) |
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
| score on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 1.00 (0.00 to 3.00) |
| 4 weeks | 2.00 (0.00 to 3.00) |
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
| score on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 0.00 (0.00 to 2.00) |
| 4 weeks | 0.00 (0.00 to 2.00) |
As measured by goniometer
No measurements were reported for this outcome.
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
| participants | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Number of Participants With Decreased Pain Medication Use | 4 |
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
| participants | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Number of Participants With Escalated Pain Medication Use | 1 |
As self-reported by participants the number of days missed over the length of the study.
| Days | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 0.00 (0.00 to 2.00) |
| 4 weeks | 0.00 (0.00 to 3.00) |
As reported by participants
| number of dressings | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Number of Dressings Used | 13.00 (0.00 to 20.00) |
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
| score on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 44.00 ± 14.04 |
| 4 weeks | 44.80 ± 20.41 |
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
| score on a scale | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Baseline | 12.00 (2.00 to 30.00) |
| 4 weeks | 8.00 (0.00 to 25.00) |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Event | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| StingingSkin and subcutaneous tissue disorders | 6/15 |
| Age, Categorical(Participants) | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Female | 13 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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University of Miami