Hidradenitis Suppurativa
Conditions
Keywords
tunneling wound
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.
Interventions
DEVICEantibiofilm surfactant wound gel (ABWG)
ABWG is a hydro-gel applied topically using a tongue depressor
Sponsors
Next Science LLC
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbiome | Baseline, 4 weeks | As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lesion Severity as Measured by the Hurley Stage | 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). |
| Change in Pain as Measured by VAS | Baseline, 4 weeks | Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain. |
| Change HS Lesion Erythema | Baseline, 4 weeks | As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe). |
| Change in Exudate | Baseline, 4 weeks | Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). |
| Change in Range of Motion | Baseline, 4 weeks | As measured by goniometer |
| Change in Lesion Severity as Measured by HS-PGA | Baseline, 4 week | HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe) |
| Number of Participants With Escalated Pain Medication Use | 4 weeks | 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 | Baseline, 4 weeks | As self-reported by participants the number of days missed over the length of the study. |
| Number of Dressings Used | 4 weeks | As reported by participants |
| Change in Quality of Life as Measured by HiSQOL | 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 |
| Change in Quality of Life as Measured by DLQI | 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 |
| Number of Participants With Decreased Pain Medication Use | 4 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Antibiofilm Surfactant Wound Gel (ABWG) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change in Microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
Time frame: Baseline, 4 weeks
Population: Only 8 patients of the 15 had with enough tissue sample for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Microbiome | Baseline | 5.46 colony forming units per ml (CFU/ml) | Standard Deviation 1.85 |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Microbiome | 4 weeks | 3.88 colony forming units per ml (CFU/ml) | Standard Deviation 1.09 |
Secondary
Change HS Lesion Erythema
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change HS Lesion Erythema | Baseline | 1.00 score on a scale |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change HS Lesion Erythema | 4 weeks | 2.00 score on a scale |
Secondary
Change in Exudate
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Exudate | Baseline | 0.00 score on a scale |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Exudate | 4 weeks | 0.00 score on a scale |
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)
Time frame: Baseline, 4 week
Population: this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Lesion Severity as Measured by HS-PGA | Baseline | 3.00 units on a scale |
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).
Time frame: Baseline, 4 weeks
Population: this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Lesion Severity as Measured by the Hurley Stage | Baseline | 2.00 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Number of Days of Work/School Lost | Baseline | 0.00 Days |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Number of Days of Work/School Lost | 4 weeks | 0.00 Days |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Pain as Measured by VAS | Baseline | 1.40 units on a scale |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Pain as Measured by VAS | 4 weeks | 0.96 units on a scale |
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
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Quality of Life as Measured by DLQI | Baseline | 12.00 score on a scale |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Quality of Life as Measured by DLQI | 4 weeks | 8.00 score on a scale |
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
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Quality of Life as Measured by HiSQOL | Baseline | 44.00 score on a scale | Standard Deviation 14.04 |
| Antibiofilm Surfactant Wound Gel (ABWG) | Change in Quality of Life as Measured by HiSQOL | 4 weeks | 44.80 score on a scale | Standard Deviation 20.41 |
Secondary
Change in Range of Motion
As measured by goniometer
Time frame: Baseline, 4 weeks
Population: 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.
Secondary
Number of Dressings Used
As reported by participants
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Number of Dressings Used | 13.00 number of dressings |
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
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Number of Participants With Decreased Pain Medication Use | 4 participants |
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
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antibiofilm Surfactant Wound Gel (ABWG) | Number of Participants With Escalated Pain Medication Use | 1 participants |