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Hidradenitis Suppurativa (HS) Tunneling Wounds

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ClinicalTrials.gov Identifier: NCT04648631
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Next Science LLC
Information provided by (Responsible Party):
Hadar Lev-Tov, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Device: antibiofilm surfactant wound gel (ABWG) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in microbiome [ Time Frame: Baseline, 4 weeks ]
    As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.


Secondary Outcome Measures :
  1. Change in lesion severity as measured by HS-PGA [ Time Frame: Baseline, 4 weeks ]
    HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)

  2. Change in lesion severity as measured by the Hurley Stage [ Time Frame: Baseline, 4 weeks ]
    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).

  3. Change in pain as measured by VAS [ Time Frame: Baseline, 4 weeks ]
    Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.

  4. Change HS lesion erythema [ Time Frame: Baseline, 4 weeks ]
    As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).

  5. Change in exudate [ Time Frame: Baseline, 4 weeks ]
    Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).

  6. Change in range of motion [ Time Frame: Baseline, 4 weeks ]
    As measured by a goniometer

  7. Number of participants with decreased pain medication use [ Time Frame: 4 weeks ]
    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

  8. Number of participants with escalated pain medication use [ Time Frame: 4 weeks ]
    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

  9. Change in number of days of work/school lost [ Time Frame: Baseline, 4 weeks ]
    As reported by participants

  10. Number of dressings used [ Time Frame: 4 weeks ]
    As reported by participants

  11. Change in quality of life as measured by HiSQOL [ Time Frame: Baseline, 4 weeks ]
    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

  12. Change in quality of life as measured by DLQI [ Time Frame: Baseline, 4 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648631


Contacts
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Contact: Hadar Lev-Tov, MD 305-243-8485 hlevtov@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Hadar Lev-Tov, MD    305-243-8485    hlevtov@med.miami.edu   
Principal Investigator: Hadar Lev-Tov, MD         
Sponsors and Collaborators
University of Miami
Next Science LLC
Investigators
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Principal Investigator: Hadar Lev-Tov, MD University of Miami
More Information
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Responsible Party: Hadar Lev-Tov, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04648631    
Other Study ID Numbers: 20201035
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hadar Lev-Tov, University of Miami:
tunneling wound
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Pulmonary Surfactants
Respiratory System Agents