Hidradenitis Suppurativa (HS) Tunneling Wounds

Hidradenitis Suppurativa Clinical Trial

Official title:

The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648631
• Other study ID #: 20201035
• Status: Completed
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults 18 years old and older

2. Have diagnosis of HS confirmed by a dermatologist

3. Have at least one HS related tunneling wound that is at least 2 centimeters in length

4. Able to provide informed consent

Exclusion Criteria:

1. Individuals who are not yet adults

2. Women known to be pregnant

3. Prisoners

4. Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Device:
• antibiofilm surfactant wound gel (ABWG)
ABWG is a hydro-gel applied topically using a tongue depressor

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Next Science LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microbiome	As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.	Baseline, 4 weeks
Secondary	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 week
Secondary	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
Secondary	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
Secondary	Change HS Lesion Erythema	As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).	Baseline, 4 weeks
Secondary	Change in Exudate	Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).	Baseline, 4 weeks
Secondary	Change in Range of Motion	As measured by goniometer	Baseline, 4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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.	Baseline, 4 weeks
Secondary	Number of Dressings Used	As reported by participants	4 weeks
Secondary	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
Secondary	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