Hidradenitis Suppurativa
Conditions
Brief summary
The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.
Interventions
DEVICEBioelectric Dressing
Procellera is single layer, broad-spectrum antimicrobial wound dressing. Embedded in the dressing are microcell batteries made of elemental silver and zinc applied in a dot-matrix pattern. The bioelectric dressing will be applied to surgical site wound with a hydrogel.
Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
Sponsors
University of Miami
Vomaris Innovations
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years old and older. * Have diagnosis of HS confirmed by a dermatologist * Have at least two ancillary tunnels in separate anatomical sites * Able to provide informed consent
Exclusion criteria
* Individuals who are not yet adults * Subject is allergic to any of the materials and dressings involved in the procedures * Women known to be pregnant * Prisoners * Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Rate | Up to 8 weeks | The healing rate of post-surgical wounds will be reported as the area reduction in cm\^2/per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Time to Complete Healing | Up to 8 weeks | The average time, measured in the number of days, to complete healing as assessed by treating physician will be reported |
| Number of Subjects With Complete Healing | Up to 8 weeks | The number of subjects with complete post-surgical site healing, as evaluated by treating physician, will be reported. |
| Number of Subjects With Nodule and/or Tunnel Recurrence | Up to 8 weeks | The number of subjects with nodule and/or tunnel recurrence, as evaluated by treating physician, will be reported. |
| Average Pain as Assessed by the Visual Analogue Scale (VAS) | Up to 8 weeks | The average pain will be measured using the VAS with scores ranging from 0-100 with the higher score indicating more severe pain. Mean change in score will be compared from baseline to last visit. |
| Number of Subjects With Tenderness at Surgical Sites | Up to 8 weeks | The number of subjects with tenderness at surgical sites, as evaluated by treating physician, will be reported. |
| Quality of Post-surgical Scars as Measured by Modified Vancouver Scar Scale | Up to 8 weeks | The Modified Vancouver Scar Scale (MVSS) is a validated clinical tool used to assess scar quality. It includes four subscales: Vascularity (0-3), Pigmentation (0-2), Pliability (0-5), Height/Thickness (0-3). Each subscale is scored independently, and the scores are summed to produce a total score ranging from 0 to 13. Higher scores indicate worse scar quality (greater abnormality). Lower scores indicate better scar quality (closer to normal skin). |
| Amount of Exudate at Surgical Site | Up to 8 weeks | The amount of exudate at surgical site will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking). Mean change in score will be compared from baseline to last visit. |
| Shoulder Range of Motion | Up to 8 weeks | Shoulder range of motion will be measured using a goniometer. Participant number with preserved range of motion will be reported. |
| Number of Dressings Used Through to Healing Day | Up to 8 weeks | The number of dressings used through to healing day will be reported. Mean change in number of dressings will be compared from baseline to last visit. |
| Days of Work Lost | Up to 8 weeks | Number of reported days of work lost due to the procedure will be reported |
| Change in Quality of Life as Measured by the DLQI | Baseline, Up to 8 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. Mean change in score will be compared from baseline to last visit. |
| Tissue Analysis of Microbiome | Up to 8 weeks | As measured by quantitative 16s recombinant DNA (rDNA) Polymerase Chain Reaction for bacterial enumeration from punch biopsy and biofilm samples. Mean change in bacterial load from baseline and final visit will be compared and reported in log Colony Forming Unit (CFU)/gram. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHadar Lev-Tov, MD
University of Miami
Participant flow
Recruitment details
Participants undergoing standard of care deroofing surgery in a medical clinic office will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing (e.g., left armpit) and the contralateral axilla (right axilla) will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
Pre-assignment details
Participants undergoing standard of care deroofing surgery in a medical clinic office will be randomized to dressing assignment per axilla: one axilla will receive the bioelectric dressing (e.g., left armpit) and the contralateral axilla (right axilla) will receive the standard gauze dressing for up to 8 weeks. Side assignment (right vs. left) will be determined by randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed