Hidradenitis Suppurativa (HS) Tunneling Wounds

The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds

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 Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Device: antibiofilm surfactant wound gel (ABWG)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABWG; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Microbiome	As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change HS Lesion Erythema	As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).	Baseline, 4 weeks
Change in Exudate	Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).	Baseline, 4 weeks
Change in Range of Motion	As measured by goniometer	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	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	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.	Baseline, 4 weeks
Number of Dressings Used	As reported by participants	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	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	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Next Science LLC
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tunneling wound
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 20201035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No