search
Back to results

Hidradenitis Suppurativa (HS) Tunneling Wounds

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
antibiofilm surfactant wound gel (ABWG)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring tunneling wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABWG

Arm Description

The participants in this group will be receiving the ABWG daily for 4 consecutive weeks.

Outcomes

Primary Outcome Measures

Change in microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.

Secondary Outcome Measures

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)
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).
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.
Change HS lesion erythema
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Change in exudate
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Change in range of motion
As measured by a goniometer
Number of participants with decreased pain medication use
Change in 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
Number of participants with escalated pain medication use
Change in 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 number of days of work/school lost
As reported by participants
Number of dressings used
As reported by participants
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
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

Full Information

First Posted
November 23, 2020
Last Updated
February 21, 2023
Sponsor
University of Miami
Collaborators
Next Science LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04648631
Brief Title
Hidradenitis Suppurativa (HS) Tunneling Wounds
Official Title
The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Next Science LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
tunneling wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABWG
Arm Type
Experimental
Arm Description
The participants in this group will be receiving the ABWG daily for 4 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
antibiofilm surfactant wound gel (ABWG)
Intervention Description
ABWG is a hydro-gel applied topically using a tongue depressor
Primary Outcome Measure Information:
Title
Change in microbiome
Description
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in lesion severity as measured by HS-PGA
Description
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 weeks
Title
Change in lesion severity as measured by the Hurley Stage
Description
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
Title
Change in pain as measured by VAS
Description
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
Title
Change HS lesion erythema
Description
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Time Frame
Baseline, 4 weeks
Title
Change in exudate
Description
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Time Frame
Baseline, 4 weeks
Title
Change in range of motion
Description
As measured by a goniometer
Time Frame
Baseline, 4 weeks
Title
Number of participants with decreased pain medication use
Description
Change in 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
Title
Number of participants with escalated pain medication use
Description
Change in 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
Title
Change in number of days of work/school lost
Description
As reported by participants
Time Frame
Baseline, 4 weeks
Title
Number of dressings used
Description
As reported by participants
Time Frame
4 weeks
Title
Change in quality of life as measured by HiSQOL
Description
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
Title
Change in quality of life as measured by DLQI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hidradenitis Suppurativa (HS) Tunneling Wounds

We'll reach out to this number within 24 hrs