A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)
Phase: NA
Conditions: Hidradenitis Suppurativa
Sponsor: University of Miami

Date:  February 16, 2023
Version:  3
Page 1 of 18 
eProst #:  20210621
Principal Investigator:  Hadar Lev-Tov, MD
Study Title:  A bioelectric dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa
NCT #: NCT05057429 
1) Objectives:
Our overall hypothesis is that a bioelectric dressing will enhance wound healing rate in 
people with hidradenitis suppurativa (HS) undergoing a deroofing procedure. We further 
hypothesize that in this population a bioelectric dressing will improve the following short- and 
medium-term outcomes: pain, range of motion and recurrence rate. We also hypothesize that this 
effect will be at least partially mediated by reduced inflammation. Finally, we hypothesize that the 
microbiome of treated wounds will be different compared to controls.  
Our specific hypotheses for this project are:

H1: The healing rate of post-surgical wounds, as determined by area reduction over time 
will be higher in the treatment group.

H2: The time to complete healing will be shorter in the treatment group.

H3: The short-term recurrence rate, as defined by new nodules or tunnels in the treated area 
at the week 8 visit, will be lower in the treatment group.

H4: The microbiome population as characterized by whole shotgun metagenomic 
sequencing will significantly differ between the treatment groups at days 14 and 28 
compared to day 0.
2) Background:
Hidradenitis Suppurativa (HS) is a chronic inflammatory disease characterized by painful 
inflammatory skin nodules, abscesses and tunneling wounds. Global estimates of prevalence for 
HS vary between 0.03% and 4%.1 Currently, part of standard of care for HS tunnels is a de-roofing 
procedure in which the skin above the tunnel is excised and the tunnel is then allowed to heal by 
secondary intention. This tissue-saving surgical technique is generally reserved for patients with 
mild-to-moderate HS. However, there exist unmet needs as the de-roofing procedure is 
accompanied by pain and prolonged healing time. Additionally, it remains unclear whether de-
roofing prevents localized recurrence of disease. Treatment after de-roofing remains a clinical 
challenge due to the location of wounds in skin folds of young, active patients. Still further, 
dressings used post-surgical intervention are only inclusive of moistened plain gauze; specialized 
dressings, however, may help facilitate healing time and improve patient outcomes. Procellera®, 
a specialized bioelectric wound dressing that generates electricity to support the body’s natural 
healing process, may be a potential therapy for patients with HS who have undergone deroofing 
procedures.
Procellera®, a specialized wound dressing with microcurrent technology, has 
demonstrated electricidal antimicrobial efficacy2,3 and enhances wound repair.4-7 Procellera® has 
been shown to enhance wound repair through faster keratinocyte migration4, increased re-
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 2 of 18 
epithelialization rate5,6, and reduced healing time5-7. Additionally, galvanic coupled elemental zinc 
and copper microparticles which make up Procellera®, have anti-inflammatory effects on skin 
mediated via anti TNF-Alpha and interlukin-18. These pathways have been implicated in the 
pathogenesis of HS9. 
Here, we propose a pilot study to determine if Procellera® accelerates healing and reduces 
signs of inflammation, including pain, after de-roofing of HS tunnels. 12 patients with at least two 
axillary HS tunnels will be recruited to participate in the study to undergo a same day dual de-
roofing procedure with Procellera® applied onto one of the post-procedure sites. The patients will 
be followed 3 days after surgery, 1 week after surgery, 2 weeks after surgery, 4 weeks after surgery 
and 8 weeks after surgery. If acceptable, a future study will be conducted with longer term, follow 
up of participants.
3) Inclusion and Exclusion Criteria*
Inclusion criteria
1. Adults 18 years old and older.
2. Have diagnosis of HS confirmed by a dermatologist.
3. Have at least two axillary tunnels in separate anatomical sites. 
4. Able to provide informed consent.
Exclusion criteria:
1. Individuals who are not yet adults.
2. Subject is allergic to any of the materials and dressings involved in the procedures. 
3. Women known to be pregnant. 
4. Prisoners.
5. Subjects, who in the opinion of the PI, cannot comply with hope application of the 
treatment. 
4) Number of Subjects*
We intend to recruit 12 subjects.
5) Study-Wide Recruitment Methods*
Patients with HS seen for their routine care at the Dermatology Outpatient Clinics at the 
University of Miami Hospital, South Miami satellite site, or Lennar Medical Foundation satellite 
site will be identified for possible study eligibility by any of the dermatologists in our practice. If 
the treating dermatologist is a study team member, they will ask the potential subject if they would 
be interested in being contacted by the study team to learn more about a research study for HS. A 
partial HIPAA waiver is needed, so that if the patient gives permission to be contacted, they will 
then be approached by a member of the study team while they are in clinic or if that is not feasible 
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 3 of 18 
then the treating dermatologist will ask if the patient would like to be contacted by telephone. If 
the treating dermatologist is not a study team member, they will ask the potential subject to contact 
the study team for more information by providing the study team’s contact information and/or the 
study flyer. If the potential subject agrees to be contacted by the study team, the treating physician 
will ask the patient to sign a PHI release authorization form, so that the physician can provide the 
study team the patient’s contact information. If it is then determined that they are interested in 
participating, they will be scheduled for a visit with the PI at our University of Miami Hospital 
dermatology clinic site where informed consent and all other study procedures will take place. The 
risks/benefits of the study will be presented to the subjects, as well as the disclaimer that refusal 
to participate in the study will in no way, shape, or form alter the type or quality of their care.
A partial HIPAA waiver is also needed as patients diagnosed with HS who signed the 
University of Miami’s Consent to Contact consent during their routine medical care will be 
identified using research IT and URIDE. Each of those individuals with then be contacted by the 
phone by a study team member and asked if they would be interested in learning more about a 
research study on HS. If it is then determined that they are interested in participating, they will be 
scheduled for a visit with the PI at our University of Miami Hospital dermatology clinic site where 
informed consent and all other study procedures will take place. The risks/benefits of the study 
will be presented to the subjects, as well as the disclaimer that refusal to participate in the study 
will in no way, shape, or form alter the type or quality of their care.
6) Study Timelines*
We intend to enroll subjects over a one-year period from the date of IRB approval. Each subject 
will participate in the study for a total of 14 months. The initial portion of the study will be 8 weeks 
(V1 to V6; 56 days +/- 3) and the second portion of the study will 12 months after V6, and consists 
if 1 final visit at the 14 months (+/- 30 days) mark . Each subject will be invited for 7 visits: initial 
visit, follow up visits and a final visit. 
7) Study Endpoints*
Primary endpoints 
The primary endpoint of the study is the difference in healing rate between the treatment and 
control arms at 8 weeks.
Secondary endpoints
Secondary outcomes include: 

The difference in the average time to complete healing in days between the study arms

The number of subjects with complete healing at each time point

The number of subjects with nodule and/or tunnel recurrence at 8 weeks

The difference in the average pain numeric scale at each time point between the two 
treatment groups

The difference in the number of subjects with tenderness at surgical sites at each time 
point
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 4 of 18 

Quality of post-surgical scar between sites

Amount and quality of exudate at surgical site

Range of motion difference between surgical sites

Number of dressings used through to healing day

Pain immediately after surgical procedure versus pain 24 hours post procedure

Days of work lost

HS Quality of Life and Dermatology Quality of Life Index (DQLI) change 

Overall cost per wound site (dressings used, pain medication used, days of work lost)

Tissue analysis (biofilm, microbiome, immunohistochemistry analysis) 
8) Procedures Involved*
After informed consent is obtained from each subject, they will be invited to participate in 
the study for 7 visits over a total of 14 months. The procedures involved are listed in the table of 
assessments
At the first visit, the surgical sites of interest will be identified, and a photo of the sites  will 
be taken. The area in the bilateral axillae will be cleaned, then anesthetized using local anesthesia. 
Once the areas are properly anesthetized, a probe will be inserted into the tunnels to identify the 
terminal ends. An incision is then made along the probe and the tunnel exposed. All skin overlaying 
the tunnel and the base of the tunnel will then be removed and the wound edge beveled. Hemostasis 
will be achieved. Once hemostasis is achieved, a second picture will be taken of the surgical 
wounds. The initial area of the wounds will be measured.  The bioelectric dressing with its 
hydrogel will then be applied to one surgical sites and a control dressing to the other based on a 
randomization sequence. The control dressing is the current standard of care which Vaseline and 
non-adherent gauze. A secondary absorbent dressing will then be applied as needed.
In the days between visits, the subjects will change the secondary dressings. 
At each visit a focused physical exam will be performed. The corresponding HS-PGA 
(Table 1) and Hurley Stage (Table 2) will be calculated.  The HS lesion locations will be marked 
on a HS Lesion Body Map (Table 3) and will also be photographed using standard photography
 At each visit, the subject’s pain on a visual analog scale, amount of pain medication used, 
number of dressings used, quality of life, and number of work/school days lost will also be 
quantified. Wound site exudate will be graded based on the Table 4 below. HS lesion erythema 
will be graded on the Clinical Erythema Assessment (CEA) scale (Table 5) at each visit. Active 
shoulder range of motion in degrees of the will be measured and recorded using a goniometer in 
the following directions: flexion, extension, and, abduction (Table 6)
At the first visit the excised tissue will be collected for tissue analysis in the laboratory. At 
visits 4 and 5, if the wound is not healed, the base of the wound will be debrided and the tissue 
sent for laboratory analysis. Additional debridement may occur during other visits based on the PI 
clinical judgment.
Data and specimens can be accessed by approved study personnel only.
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 5 of 18 
If the wounds heal within the 8 weeks visit (Visit 6), the subject will complete all visits 
and assessments and will then referred back to the referring physician for continued medica care. 
If the wound does not heal, the subject will be referred to their referring physician and will be 
offered follow up with the PI. 
At the 14 months follow-up visit, subjects will undergo a physical examination of their scars at 
the healed surgical sites as part of the surgery performed in the study. Subjects will be asked 
about any recurrence in the areas treated (lesions at the surgical site, near the surgical site and/or 
elsewhere), satisfaction with the procedure and any procedure related adverse events. Scars will 
be evaluated using the Modified Vancouver Scar Scale (Table 7) and the observer portion of the 
Patient and Observer Scar Assessment Scale (POSAS) (Table 8). Patients will also be asked to 
fill the patient portion of the Patient and Observer Scar Assessment Scale POSAS (Table 8) and 
the Patient Scar Assessment Questionnaire, along with the quality-of-life questionnaires that 
were filled at previous visits. The scars at the surgical sites operated as part of the study will also 
be photographed using standard photography. A focused physical exam will be performed. The 
corresponding HS-PGA (Table 1) and Hurley Stage (Table 2) will be calculated.  The HS lesion 
locations will be marked on a HS Lesion Body Map (Table 3) and will also be photographed 
using standard photography. In the event of recurrence at the surgical sites, HS lesion erythema 
will be graded on the Clinical Erythema Assessment (CEA) scale (Table 5) at each visit. Active 
shoulder range of motion in degrees of the will be measured and recorded using a goniometer in 
the following directions: flexion, extension, and abduction (Table 6).
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 6 of 18 
Table of Assessments
Week
0
0
1
2
4
8
14
Day
0
3
7
14
28
56
421
Visit
V1
V2
V3
V4
V5
V6
V7
Window (days)
0
±3
±3
±3
±3
±3
±30
Informed consent
X
Eligibility 
X
Subject ID assignment
X
Demographics
X
HS history
X
Medical history
X
Concomitant medication
X
X
X
X
X
X
X
Physical exam (focused)
X
X
X
X
X
X
X
HS lesion map
X
X
X
X
X
X
X
Randomization
X
HS lesion ultrasound
X
X
Hurley stage
X
X
X
X
X
X
X
HS-PGA
X
X
X
X
X
X
X
Pain (VAS) -General
X
X
X
X
X
X
X
Pain (VAS) -surgical sites
X
X
X
X
X
X
X
Surgical site tenderness
X
X
X
X
X
X
X
Pain medication usage past 3 days
X
X
X
X
X
X
X
Wound area
X
X
X
X
X
X
Scar assessment
X
X
X
X
X
X
Height 
X
X
X
Body weight
X
X
X
Exudate
X
X
X
X
X
X
X
Erythema
X
X
X
X
X
X
X
Range of motion affected joint
X
X
X
X
X
X
X
Deroofing
X
Product/SOC application
X
X
X
X
X
X
Tissue collection
X
X
X
QOL (DLQI)
X
X
X
Patient-reported scar assessment
X
Work/school days lost
X
X
X
X
X
X
X
Number of dressing used (per site)
X
X
X
X
X
X
Photography
X
X
X
X
X
X
X
Ease of dressing application
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 7 of 18 
Table 1:  HS PGA Scale
Table 2: Hurley Score
Stage 1
Single or multiple abscesses without sinus tract formation or scarring
Stage 2
Recurrent abscesses with one or more sinus tracts and scarring widely separated 
by normal skin
Stage 3
Diffuse involvement with multiple sinus tracts and no intervening   normal skin
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 8 of 18 
Table 3: Body Map
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 9 of 18 
Table 4: Exudate Evaluation
Indicators
Status
Wound bed
Dressing
Surrounding skin
Dry
Wound bed is dry; 
there is no visible 
moisture
Primary dressing is unmarked; 
dressing may be adherent to 
wound
Skin may be scaly, 
atrophic, 
hyperkeratotic
Moist
Small amounts of 
fluid are visible 
when dressing is 
removed; wound 
bed may appear 
glossy
Primary dressing may be lightly 
marked; dressing change 
frequency is appropriate
Skin is likely to be 
intact, hydrated, no 
lesions
Wet
Small amounts of 
fluid are visible 
when the dressing is 
removed
Primary dressing is extensively 
marked, but strikethrough does 
not occur; appropriate dressing 
change frequency
Initial fragmented 
areas of maceration 
may be apparent
Saturated
Free fluid is visible 
when the dressing is 
removed
Primary dressing is wet and 
strikethrough occurs; dressing 
change is required more 
frequently than usual
Peri-wound skin is 
likely to be macerated 
or denuded with 
extensive involvement
Leaking
Free fluid is visible 
when the dressing is 
removed
Dressings are saturated and 
exudate is escaping from primary 
and secondary dressings onto 
clothes or beyond; dressing 
change is required much more 
frequently than usual
Peri wound skin is 
likely to be macerated 
or denuded with 
extensive involvement
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 10 of 18 
Table 5: Clinician Erythema Assessment (CEA)
Table 6. Shoulder range of motion evaluation 
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 11 of 18 
Table 7. Modified Vancouver Scar Scale
Table 8. The Patient and Observer Scar Assessment Scale POSAS
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 12 of 18 
9) Data and Specimen Banking*
Study records including informed consents and source documents will be stored in a locked 
cabinet in the Dermatology Clinical Trials Unit at University of Miami (University of Miami 
Hospital West Building, 1321 NW 14th St, Suites 504-508, 33136).
Collected samples will be assigned numeric identifiers (subject ID, visit and date of 
collection).  Specimens will be banked for future use and kept under lock in the Pastar 
laboratory (1600 NW 10th Ave, RMSB 6056, Miami FL 33136). 
All specimens will be stored at -80°C in the laboratory (1600 NW 10th Ave, RMSB 6056, 
Miami FL 33136).  
10) Data and Specimen Management
Data collected will be analyzed by study staff. All study data will be saved on UM computers 
that are password protected. After initial data collection, all data analyses will be conducted in 
aggregates and will be de-identified. 
11) Provisions to Monitor the Data to Ensure the Safety of Subjects*
This study involves procedures that are within the standard care spectrum for HS. However, 
the safety of subjects is the primary objective of the PI and the study staff. All subjects will be 
evaluated for adverse events routinely at every study visit. PI and study staff will actively solicit 
relevant adverse events. Subjects will also be provided with contact information and encouraged 
to contact PI and study staff with any concern or emerging adverse event. Since this is small, 
unblinded study, a data monitoring committee is not required. 
Data recorded in the subject’s CRF will be reviewed for specific adverse event including: 
pain, fever, chills, bleeding, burning or discomfort from product application. Since all procedures 
conducted are within the scope of standard care, we do not expect significant adverse events above 
and beyond the usual events associated with minimally invasive surgical procedure (i.e. incision 
and drainage). However, if a subject dies or experiences admission to the hospital due to adverse 
event that is involving the treatment site or any serious adverse event that is directly related to the 
study procedure, the PI will pause the study for assessment and decide if to continue the study. 
12) Withdrawal of Subjects
Although unlikely, a subject may withdraw from the study at any time at their own request. 
Subjects may also be withdrawn at any time at the discretion of the PI due to concerns about safety, 
behavioral, compliance, or administrative reasons. 
At the time of discontinuing from the study, visit 6 relevant assessments will be conducted. 
Subjects will be questioned regarding their reason for withdrawal and reasons will documented in 
the CRF.  If the subject withdraws from the study and also withdraws consent (see below) for 
disclosure of future information, no further evaluations will be performed, and no additional data 
will be collected. The PI may retain and continue to use any data collected before such withdrawal 
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 13 of 18 
of consent. If a subject withdraws from the study due a SAE, the SAE will be recorded in the CRF 
and reported to the IRB. Lack of completion of all or any of the withdrawal/early termination 
procedures will not be viewed as protocol deviations so long as the participant’s safety was 
preserved. 
Withdrawal of Consent: 
Subjects who request to discontinue receipt of study treatment will remain in the study and 
must continue to be followed per protocol. The only exception to this will be when a subject 
specifically withdraws consent for any further contact. Subjects should notify the PI or staff of the 
decision to withdraw consent from future follow-up and this will be recorded in the CRF. The 
withdrawal of consent should be explained in detail in the CRF, as to whether the withdrawal is 
only from further receipt of treatments or also from study procedures and/or posttreatment study 
follow-up. 
13) Risks to Subjects*
The procedures involved in the study are within the standard care for people with HS and 
are indicated. Therefore, the main added risk we anticipate is unintentional reveal of PHI. 
Additional risks that are inherent in the standard care treatment include: pain, bleeding, 
infection and abnormal scarring that are related to the surgical procedures. There are minimal 
risks associated with the use of the bioelectric and control dressing that include rash, stinging or 
burning at the application site. 
14) Potential Benefits to Subjects*
Regardless of the research outcomes, the patients will benefit from immediate symptom 
relief. They will also have better healing of the lesions. They may also experience no recurrence 
in the areas treated. If our hypothesis is correct, they will be spared worsening of disease. Given 
the poor overall management of HS nationwide, patients will benefit from care at an expert medical 
center. Patients will also have access to free dressing and wound care for the duration of the study 
which are infrequently covered for HS. 
15) Vulnerable Populations*
This research study does not include vulnerable populations. Specifically, we will not enroll 
minors, pregnant women, prisoners, or cognitively impaired people.  
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 14 of 18 
16) Multi-Site Research*
This is a single site study.
17) Community-Based Participatory Research*
This study was designed without CBPR.
18) Sharing of Results with Subjects*
There are no results to share with the subjects.
19) Setting
Clinical study activities will take place in the Dermatology Clinical Trials Unit at University 
of Miami (University of Miami Hospital West Building, 1321 NW 14th St, Suites 504-507, 33136) 
and the Dermatology clinic at UMH (1295 NW 14th St suite K/L/M, Miami, FL 33125).
Laboratory 
analysis 
activities 
will 
take 
place 
in the Pastar 
laboratory (1600 
NW 
10th Ave, RMSB 6056, 
Miami 
FL 
33136). All 
specimens 
will 
be 
stored 
at -
80°C in the laboratory (1600 NW 10th Ave, RMSB 6056, Miami FL 33136). 
This study is open to all eligible subjects. Recruitment efforts will focus on the existing 
dermatology clinics with the University of Miami Health System as well as other specialty clinics 
at UMHS where HS subjects may visit such as general surgery, plastic surgery and gynecology. 
20) Resources Available
Dr. Lev-Tov (PI) is a board-certified dermatologist with extensive experience in treating 
people with HS and the study related procedures. He has conducted many clinical trials and is 
considered a leader in the field. Dr. Pastar (co-PI) is an associate professor at UM and well 
recognized expert in the field of wound healing. She has conducted many similar studies and has 
all the expertise and equipment needed to conduct the work related to this study. 
Both Dr. Lev-Tov and Dr. Pastar will personally train all study staff on the procedures 
related to the protocol. All study team members will also complete the necessary CITI training 
modules.
Prior Approvals
No prior approvals are needed.
21)Local Number of Subjects
We plan to complete the study on 12 subjects. Given the usual attrition rate we will plan to consent 
up to 15 subjects.
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 15 of 18 
22) Confidentiality
The research team will keep all study information and samples in a locked office and 
laboratory under password protection while the database is maintained. All data and specimens 
will be de-identified and coded as described earlier. The data will be only accessible by the 
research team. 
Local transport of study specimens will be done in a sealed biohazard bag within a secondary 
container with a secured lid. 
Choose the statements below that are applicable to this research: 
26(a).  Will the research collect protected health information or personally identifiable information 
from the EMR or from subjects at UHealth and/or JHS?
☒  Yes (If checked go to 26(b))
☐  No (If checked, go to  Section 27)
26(b).  Check the box next to the correct statement below 
☒   Research Subjects will sign a HIPAA Authorization before the research will collect this data. 
☐   Research Subjects will not sign a HIPAA Authorization for this data collection and the 
research is requesting a waiver of HIPAA authorization from the IRB.  
26(c).  How will the research store the data? 
☒  On a University of Miami electronic device (e.g. encrypted, password-protected computer)
☐  On a cloud-based storage system that is approved by the University of Miami 
☐  On the secured JHS SharePoint environment. 
☐  Other, specify:  Click here to enter text.
26(d) Select one of the following: 
☐  The Principal Investigator (and/or Study Team members) will record (e.g. write down, 
abstract) data acquired in a manner that does not include any indirect or direct identifiers (listed in 
the instructions for Section 26 of this protocol), and the recorded data will not be linked to the 
individual’s’ identity.  
   OR
☒  The Principal investigator (and/or Study Team members) will record (e.g. write down, 
abstract) the data collected in a manner that does not include any direct identifiers (see list in the 
instructions for Section 26 of this protocol) of any subject. Instead, the Principal Investigator 
and/or Study Team members will assign a code (that is not derived in whole or in part from any 
direct or indirect identifiers of the individual) to each study subject and link the code to the study 
subject’s identity. The link to each subject’s identity and/ or other identifiable information will be 
maintained on a document separate from the research data. 
26(e)  Additional requirement for Jackson Health System Data:
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 16 of 18 
  
 Not-applicable, no data will be acquired from JHS under a waiver of authorization. 
  JHS data, including Protected Health Information (PHI) and/or Personally Identifiable 
Information (PII), acquired from JHS for this research under a waiver of authorization shall only 
be stored on the secured JHS SharePoint environment made available by JHS. I and the Study 
Team members shall not copy or store the JHS sourced personally identifiable information (PII), 
including protected health information (PHI) data to any other system, including any systems 
maintained or provided by the University of Miami. I and the Study Team shall only copy or 
transfer JHS-sourced data that has been properly de-identified in accordance with all requirements 
contained in the HIPAA Rules by removing all of the identifiers listed in the instructions for 
Section 26 of this protocol.
23) Biospecimens
  Not applicable.  No biospecimens will be collected
  Bio-Specimens obtained for this research will be stored without any   direct or indirect 
identifiers.  
 
 Bio-Specimens obtained for this research will be stored in a de-identified coded manner.   
   When required to transport data or bio-specimens for this research, the research team will 
transport the data and bio-specimens in a de-identified (or anonymous) manner with a link to the 
individual subject’s identity maintain separately from the data and/or bio-specimen.
24) Provisions to Protect the Privacy Interests of Subjects
Study subjects will only be asked to provide personal information to approved study personnel, 
who will ensure the subject is at ease with the situation. Study personnel will clearly explain that 
the subject does not have to answer any questions or provide any sample they are uncomfortable 
about. 
Compensation for Research-Related Injury
If the research involves more than Minimal Risk to subjects, describe the available compensation 
in the event of research related injury.
Provide a copy of contract language, if any, relevant to compensation for research-related injury.
25) Economic Burden to Subjects
The study subjects will not have to pay for any procedure involved in the research study.
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 17 of 18 
26) Consent Process
The research team will follow the “HRP-090 SOP: Informed Consent Process for Research” to 
obtain informed consent and the “HRP-091 SOP: Written Documentation of Informed Consent” 
to document informed consent in writing.
The consent and assent will be translated into Spanish for the inclusion of non-English Spanish 
speakers.
Study personnel will meet with each potential subject to discuss the study in detail, answer 
questions, and allow the subject to read the entire consent form. The informed consent form 
explicitly states the rationale for the study and requirements for participation, both before and 
during the session. The informed consent form states that subjects may discontinue participation 
or be terminated from the study at any time. 
All pertinent aspects of the study will be explained to the subject before he or she signs the 
informed consent form. A signed informed consent form will be obtained from the subject before 
any activity is undertaken as part of the study. 
Process to Document Consent in Writing
The research team will follow the “HRP--091 SOP: Written Documentation of Informed Consent” 
to document informed consent in writing.
27) Authorization for Use and Disclosure of Protected Health Information 
(HIPAA) 
Type of Request:
 
Waiver 
of 
Authorization 
for 
access 
to 
medical 
record 
for 
subject 
identification/recruitment.
 Waiver of Authorization for access to medical record to obtain data for the research.
Confirm that you will destroy the Protected Health Information (PHI) you and/or your Study 
Team acquire receive from JHS and/or UHealth at the earliest opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or UHealth  will 
not be re-used or disclosed to any other person or entity, except as required by law or for 
authorized oversight of the research study or for other research for which the use or disclosure 
of PHI is permissible.           
☒     I confirm  
28) Drugs or Devices
All drugs and devices used in the study will be used in a manner consistent with routine 
clinical practice and “per label”. The main study intervention is the use of a dressing marketed 
-       Study #: 20210621        Effective Date: 2/16/2023

Date:  February 16, 2023
Version:  3
Page 18 of 18 
under the name Procellera. Procellera has been cleared by the FDA for treatment of wounds (see 
FDA 510 (K) marketing approval letter attached) and will be used “per label” and routine clinical 
practice.  
29) References
1.
Ingram JR, Jenkins-Jones S, Knipe DW, Morgan CLI, Cannings-John R, Piguet V. Population-
based Clinical Practice Research Datalink study using algorithm modelling to identify the true 
burden of hidradenitis suppurativa. Br J Dermatol. 2018;178(4):917-924.
2.
Kim H, Makin I, Skiba J, et al. Antibacterial efficacy testing of a bioelectric wound dressing 
against clinical wound pathogens. Open Microbiol J. 2014;8:15-21.
3.
Banerjee J, Das Ghatak P, Roy S, et al. Silver-zinc redox-coupled electroceutical wound dressing 
disrupts bacterial biofilm. PLoS One. 2015;10(3):e0119531.
4.
Banerjee J, Das Ghatak P, Roy S, et al. Improvement of human keratinocyte migration by a redox 
active bioelectric dressing. PLoS One. 2014;9(3):e89239.
5.
Blount AL, Foster S, Rapp DA, Wilcox R. The use of bioelectric dressings in skin graft harvest 
sites: a prospective case series. J Burn Care Res. 2012;33(3):354-357.
6.
Harding AC, Gil J, Valdes J, Solis M, Davis SC. Efficacy of a bio-electric dressing in healing 
deep, partial-thickness wounds using a porcine model. Ostomy Wound Manage. 2012;58(9):50-
55.
7.
Whitcomb E, Monroe N, Hope-Higman J, Campbell P. Demonstration of a microcurrent-
generating wound care device for wound healing within a rehabilitation center patient population. 
J Am Coll Clin Wound Spec. 2012;4(2):32-39.
8.
Kaur S, Lyte P, Garay M, et al. Galvanic zinc-copper microparticles produce electrical 
stimulation that reduces the inflammatory and immune responses in skin. Arch Dermatol Res. 
2011;303(8):551-562.
9.
Wolk K, Join-Lambert O, Sabat R. Aetiology and pathogenesis of hidradenitis suppurativa. The 
British journal of dermatology. 2020;183(6):999-1010.
-       Study #: 20210621        Effective Date: 2/16/2023