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| Name | Class |
|---|---|
| Next Science LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABWG | Experimental | The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiofilm surfactant wound gel (ABWG) | Device | ABWG is a hydro-gel applied topically using a tongue depressor |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiofilm Surfactant Wound Gel (ABWG) | The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiofilm Surfactant Wound Gel (ABWG) | The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Microbiome | As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples. | Only 8 patients of the 15 had with enough tissue sample for analysis. | Posted | Mean | Standard Deviation | colony forming units per ml (CFU/ml) | Baseline, 4 weeks |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiofilm Surfactant Wound Gel (ABWG) | The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel applied topically using a tongue depressor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stinging | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | 305-689-2646 | hlevtov@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | Jan 31, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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) | this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected. | Posted | Median | Inter-Quartile Range | units on a scale | 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). | this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected. | Posted | Median | Full Range | score on a scale | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Posted | Median | Full Range | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change in Exudate | Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). | Posted | Median | Full Range | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change in Range of Motion | As measured by goniometer | Data for this outcome measure was not collected due to instrument needed for outcome measure was never received for the study, impeding the collection of this specific data point at both baseline and "4 weeks" timepoint. | Posted | 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 | Posted | Number | participants | 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 | Posted | Number | participants | 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. | Posted | Median | Full Range | Days | Baseline, 4 weeks |
|
|
|
| Secondary | Number of Dressings Used | As reported by participants | Posted | Median | Full Range | number of dressings | 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 | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Median | Full Range | score on a scale | Baseline, 4 weeks |
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 6 |
| 15 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |