The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
Phase: NA
Conditions: Hidradenitis Suppurativa
Sponsor: University of Miami

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Protocol Title:
The Microbiome of Hidradenitis Suppurativa (HS) Tunneling 
Wounds
Protocol Number:
20201035
Protocol Version #: 1.2
Protocol Version date:
05May2022
Principle Investigator Name:
Hadar Lev-Tov, MD
NCT Number:  
NCT04648631
1)
Objectives*
Our overall hypothesis is that tunneling wound (TW) formation is key in disease 
progression from local skin disease to systemic inflammatory disease. Further we 
hypothesize that biofilms present in the TW are detrimental to healing and allow 
propagation of the disease process. Our specific hypotheses for this project are:
H1: Biofilms exist in HS TW, as determined by microbiome identification and 
enumeration 
H2: antibiofilm treatment can resolve biofilms in HS TW, as determined by 
microbiome identification and enumeration, histology, or inflammatory and 
antimicrobial tissue response by host gene expression
H3: treatment of the biofilms in TW modulates the systemic host response.
2)
Background*
Hidradenitis Suppurativa (HS) is a devastating chronic skin disease affecting 
approximately 1% of the population. Currently, there is no cure for HS. Standard 
care includes combination of medical and surgical therapies. There is only one 
agent tested in RCT which provides moderate relief to about half of the patients. As 
part of disease progression, dermal and subcutaneous tunneling wounds (TW) that 
communicate with the skin’s surface form and are colonized with bacteria.1  
Emerging evidence suggests biofilms form in the TW of HS.2  Tunnel formation 
occurs when patients go from locally contained disease to having systemic 
inflammatory disease and symptoms.  While it is generally believed that the skin 
microbiome participates in the pathogenesis of HS, the presence and the role of 
biofilms in the cutaneous tunnels has not been well characterized. Additionally, if 
biofilms exist, eradication of biofilms in the TW may improve HS. We have 
reported our anecdotal success with treatment of HS TW with antibiofilm surfactant 
wound gel (ABWG,) (in submission) and we aim to prospectively examine the 
mechanisms involved. 
3)
Inclusion and Exclusion Criteria*
Inclusion criteria
1. Adults 18 years old and older
2. Have diagnosis of HS confirmed by a dermatologist
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3. Have at least one HS related tunneling wound that is at 
least 2 CM 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. 
4)
Number of Subjects*
We intend to recruit 15 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 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 
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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 4 weeks 
(28 days +/- 3). Each subject will be invited for 3 visits: initial visit, 
follow up visit and final visit. 
7)
Study Endpoints*
The primary endpoint of the study is the change in microbiome from HS 
TW before and after 4 weeks treatment with the ABWG as measured by 
quantitative 16s rDNA PCR for bacterial enumeration. 
Secondary outcomes include: Change in lesion severity (as measured by 
HS-PGA (Table 1) and Hurley Stage (Table 2)), change in pain from 
baseline (as measured by a 100 mm visual analogue scale), change from 
baseline in HS lesion erythema as measured by the Clinical Erythema 
Assessment (CEA) scale (Table 5), change from baseline in exudate 
graded from none to leaking (see Table 4), changes from baseline in range 
of motion as measured by a goniometer in the following directions: 
flexion, extension, abduction, internal and external rotation (Table 6), 
change in quantity and type of pain medication use, weekly change in 
number days of work/school lost, number of dressing used per week, 
Quality of life (using HiSQOL and DLQI).
Other descriptive measures included:

Microbiome assessment from the tissue using metagenome shotgun sequencing 
approach to identify all species and their corresponding virulence factors, 
including genes responsible for biofilm formation antibiotic resistance genes, etc.

Tissue assessment by histology

Inflammatory and antimicrobial tissue response by host gene expression before 
and after treatment for ten representative genes.

Confocal laser scanning microscopy to visualize and confirm biofilm before and 
after treatment will be performed on a small subset of subjects (about 5)

Change from baseline in serum levels of markers of inflammation such as IL-6, 
IL-8, IL-10, IL-17α, soluble TNF receptor II (sTNF-RII), C-reactive protein 
(CRP) and erythrocyte sedimentation rate (ESR). 
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8)
Procedures Involved*
After informed consent is obtained from each subject, they will be invited 
to participate in the study for 3 visits over 4 weeks. The procedures 
involved are listed in the table of assessments.
Week
0
+2
+4
Visit
V1
V2
V4
Window (days)
0
±3
±3
Informed consent
X
Eligibility 
X
Subject ID assignment
X
Chart review
X
Demographics
X
HS history
X
Medical history
X
Concomitant medication
X
X
X
Physical exam (focused)
X
X
X
HS lesion map
X
X
X
HS lesion ultrasound
X
X
X
Hurley stage
X
X
X
HS-PGA
X
X
X
Pain (VAS) -General
X
X
X
Pain (VAS) -target TW
X
X
X
Pain medication usage 
past 3 days
X
X
X
Height 
X
Body weight
X
X
Exudate
X
X
X
Erythema
X
X
X
Range of motion affected 
joint
X
X
X
Incision and drainage 
X
Product application
X
X
X
Tissue collection
X
X
Serum collection
X
X
QOL
X
X
Work/school days lost
X
X
X
Number of dressing used
X
X
X
Photography
X
X
X
Ease of ABWG 
application
X
X
X
Adverse events
X
X
X
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At the first visit, the medical history will be reviewed and demographics, 
HS history and concomitant medications will recorded using the medical chart 
and history given by the patient. Then, the tunnel of interest will be identified and 
a picture of the lesion will be taken. The first swab of the lesion will be performed 
and placed in a collection tube labeled with the patient number, date and “pre.” 
The area will be cleaned, then anesthetized using local anesthesia. Once the area 
is properly anesthetized, a punch incision will be made and the tissue placed in a 
sterile petri dish lined with gauze labeled with the patient number, date and 1. 
After the tissue is place in the dish, sterile PBS will be added to the gauze.
 A probe will then be inserted into the tunnel to identify the terminal end. 
A second punch incision will be made at the end of the tunnel and the tissue will 
be collected in a second sterile petri dish labeled with the patient number, date 
and 2.  Hemostasis will be achieved. Once hemostasis is achieved, a second 
picture will be taken of the lesion. The ABWG (BlastX, NextScience, 
Jacksonville, FL) will then be applied to both punch sites using a tongue 
depressor. Absorbent dressing will be applied to cover the wound.
 In the days between visits, patients will apply one fingertip unit of the 
ABWG to the study wound daily.
In order to correlate the change in microbiome to secondary clinical 
outcomes, 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 100mm 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 range of motion in degrees of the nearby joint 
(shoulder or hip) will be observed and recorded using a goniometer in the following 
directions: flexion, extension, abduction, internal and external rotation (Table 6). During 
the first and last visit quality of life will be assessed utilizing the Dermatology Life 
Quality Index (DLQI) and the HS Quality of Life Questioner (HiSQOL).  The DLQI 
questionnaire is designed for use in adult participants with inflammatory skin
diseases and has been used in HS studies. The DLQI surveys participants about
symptoms and feelings, daily activities, leisure, work and school, personal relationships 
and treatment. The DLQI total score ranges 0 -30 (lower scores indicating higher health
related QOL). A total score of 0 or 1 indicates no significant impact of the disease  on 
health related  QOL. A  4 point change in the DLQI total score has been reported to be a 
meaningful change in the subject’s QOL. The HiSQOL questionnaire is comprised of 17 
items and has a recall period of 7 days. The HiSQOL includes 3 subscales: symptom 
status, psychosocial impact, and impact on physical activities. It has been recently 
validated and is HS  disease specific.
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At the last visit, the lesion will be swabbed, and the sample will be 
collected per the tissue collection protocol above. The patient will then be offered 
excision of the lesion and that tissue will be collected and sent to the lab, as well.
Data and specimens can be accessed by approved study personnel only.
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
Table 3: Body Map
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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 
Primary dressing is 
extensively marked, but 
strikethrough does not 
Initial fragmented 
areas of 
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dressing is 
removed
occur; appropriate dressing 
change frequency
maceration may 
be apparent
Saturate
d
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
Table 5: Clinician Erythema Assessment (CEA)
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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)  Adverse events 
Collecting Adverse Events 
Study staff and PI are responsible for soliciting, recording and reporting any adverse 
event during the study period. In addition to unsolicited reports by subjects, the PI and 
study staff will open every visit by asking for any change in health or any other complaint 
since the last visit. 
Definition of an adverse event 
In this study an adverse event (AE) will be defined based on FDA CFR Title 21: 
“Adverse event means any untoward medical occurrence associated with the use of a 
drug in humans, whether or not considered drug related” [28]. Therefore an AE is 
considered as any unplanned medical occurrence that affects subject’s health and/or well-
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being. The adverse event need not be directly related to the study device or procedure. As 
such, an adverse event may include any unintended outcome such as a symptom or a new 
diagnosis or worsening or improvement of existing medical condition. 
Serious adverse event (SAE) is defined according to FDA CFR title 21: “Serious adverse 
event or serious suspected adverse reaction. An adverse event or suspected adverse 
reaction is considered "serious" if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: Death, a life-threatening adverse event, 
inpatient hospitalization or prolongation of existing hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct normal life 
functions, or a congenital anomaly/birth defect. Important medical events that may not 
result in death, be life-threatening, or require hospitalization may be considered serious 
when, based upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or 
convulsions that do not result in inpatient hospitalization, or the development of drug 
dependency or drug abuse”. 
A SAE is therefore an AE that: 
1. Results in death. 
2. Is life-threatening at the time of the AE. 
3. Results in an inpatient hospitalization or prolongation of existing 
hospitalization. 
4. Results in a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions. 
5. Is a congenital anomaly/birth defect. 
6. May require medical or surgical intervention to prevent one of the outcomes 
listed above. 
Documenting and reporting adverse events 
All adverse events need to be recorded and reported to the local IRB and the sponsor in a 
timely manner and in accordance to local regulations. 
Assessment of advance event causality 
For each AE the PI is responsible for assessing the relationship between study procedure 
including application of study device and the AE in order to determine causality. The 
relationship of AE to study activities will be recorded in the AE log. The PI will use the 
following terms to describe relationship of AE to study activities: 
Probable: the AE appears to follow a temporal sequence following study related 
activities, or has a dose relationship with study activities (i.e. worse when activity 
increased and visa versa) and cannot be attributed to other causes such as past medical 
history. 
Possible: the AE appears to follow a temporal sequence following study related activities, 
or has a dose relationship with study activities (i.e. worse when activity increased and 
visa versa) but could be attributed to other causes such as past medical history and other 
therapies. 
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Unlikely: the AE does not appears to follow a temporal sequence following study related 
activities, and does not demonstrate a dose relationship with study activities (i.e. worse 
when activity increased and visa versa) and could reasonably be attributed to other causes 
such as past medical history and other therapies. 
Cannot assess: the PI cannot make determination of causality at this time due to 
insufficient information and/or contradictory or unreliable information. The PI will 
frequently re-evaluate the AE in order to classify it into one of the classes above.
13)
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 3 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 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. 
14)
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 FDA 
cleared ABWG that include stinging or burning at the application site. 
15)
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 
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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. 
16)
Vulnerable Populations*
This research study does not include vulnerable populations. Specifically, 
we will not enroll minors, pregnant women, prisoners, or cognitively 
impaired people.  
17)
Multi-Site Research*
This is a single site study.
18)
Community-Based Participatory Research*
This study was designed without CBPR.
19)
Sharing of Results with Subjects*
There are no results to share with the subjects.
20)
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. 
21)
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.
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22)
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.  
23)
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 shall will assign a code (that is not 
derived in whole or in part from any direct or indirect identifiers of the individual) to 
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Page 14 of 16
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:
  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.
27. 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
25)
Compensation for Research-Related Injury
Treatment will be available if enrolled subjects get sick or injured.  
However, the subject or the subject’s insurance will be responsible for 
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these costs.  Funds to compensate for pain, expenses, lost wages, and other 
damages caused by injury are not available.
26)
Economic Burden to Subjects
The study subjects will not have to pay for any procedure involved in the 
research study.
27)
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. 
28)
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.
29)
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 
-       Study #: 20201035        Effective Date: 5/5/2022

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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  
30)
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 an anti-biofilm 
wound gel marketed under the name BlastX. BlastX 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.  
31)
References
1.
Ring HC, Sigsgaard V, Thorsen J, et al. The microbiome of tunnels in hidradenitis 
suppurativa patients. Journal of the European Academy of Dermatology and 
Venereology : JEADV 2019; 33(9): 1775-80.
2.
Ring HC, Bay L, Nilsson M, et al. Bacterial biofilm in chronic lesions of hidradenitis 
suppurativa. The British journal of dermatology 2017; 176(4): 993-1000.
-       Study #: 20201035        Effective Date: 5/5/2022