N/A
N=15
Hidradenitis Suppurativa (HS) Tunneling Wounds
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT04648631 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change in Microbiome — 5.46; 3.88 colony forming units per ml (CFU/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- antibiofilm surfactant wound gel (ABWG) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Microbiome |
5.46; 3.88 | — |
| SECONDARY Change in Lesion Severity as Measured by HS-PGA |
3.00 | — |
| SECONDARY Change in Lesion Severity as Measured by the Hurley Stage |
2.00 | — |
| SECONDARY Change in Pain as Measured by VAS |
1.40; 0.96 | — |
| SECONDARY Change HS Lesion Erythema |
1.00; 2.00 | — |
| SECONDARY Change in Exudate |
0.00; 0.00 | — |
| SECONDARY Change in Range of Motion |
— | — |
| SECONDARY Number of Participants With Decreased Pain Medication Use |
4 | — |
| SECONDARY Number of Participants With Escalated Pain Medication Use |
1 | — |
| SECONDARY Change in Number of Days of Work/School Lost |
0.00; 0.00 | — |
| SECONDARY Number of Dressings Used |
13.00 | — |
| SECONDARY Change in Quality of Life as Measured by HiSQOL |
44.00; 44.80 | — |
| SECONDARY Change in Quality of Life as Measured by DLQI |
12.00; 8.00 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04648631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.