Wound Dressings for Hidradenitis Suppurativa
Phase: NA
Conditions: Hidradenitis Suppurativa
Sponsor: University of Miami

 
 
 
 
Wound Dressing in Patients with Hidradenitis Suppurativa: A 
Pilot Study 
 
STUDY PROTOCOL 
PROTOCOL NUMBER 20191046 
NCT04194541 
 
Principal Investigator: 
Hadar Lev-Tov, MD 
Dr. Phillip Frost Department of Dermatology & Cutaneous 
Surgery, University of Miami Miller School of Medicine. 
 
Phone number: (305) 243-8485 or 305-243-1000 (24-hour page 
operator) 
Email Address: hlevtov@med.miami.edu 
 
Protocol Version No.3 Date: April 6, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 

1) 
Objectives* 
The primary purpose of this research is to determine how the types of 
wound dressings affect quality of life for people with Hidradenitis 
Suppurativa (HS). The secondary purpose is to evaluate the utility of a 
starter kit concept for wound care in people with HS. 
1. Primary outcome: quality of life as measured by the DLQI 
instrument. 
2. Secondary outcomes include:  
a. Average pain as measured on NRS 
b. Maximal pain as measured on NRS 
c. Sleep assessment as measured on 5-point likert scale 
d. Drainage assessment as measured on 4-point likert scale 
e. Odor assessment as measured on 4-point likert scale 
f. Patients’ overall preference of dressings for HS as 
measured on a 5-point likert scale 
g. Which dressings work best for which parts of the body as 
measured by patient log 
h. Frequency of dressing changes required as measured by 
patient log 
i. HS-Physician’s Global Assessment (HS-PGA)  
j.  
 
Study Endpoints: 
Primary 
endpoint 
Change in DLQI from 
baseline to week 6 
Secondary 
endpoint 
Change in average pain NRS 
from baseline to week 6 
Secondary 
endpoint 
Change in maximal pain NRS 
from baseline to week 6 
Secondary 
endpoint 
Change in sleep rating from 
baseline to week 6  
Secondary 
endpoint 
Change in drainage rating 
from baseline to week 6 
Secondary 
endpoint 
Change in odor rating from 
baseline to week 6 

Secondary 
endpoint 
Overall dressing preference 
for HS as noted by subjects on 
patient log 
Secondary 
endpoint 
Dressing preference for body 
parts as noted by subjects on 
patient log 
Secondary 
endpoint 
Average frequency of 
dressing changes as noted by 
subjects on patient log 
Secondary 
endpoint 
Change in HS-PGA at 6 
weeks after initial assessment 
 
 
2) 
Background* 
Hidradenitis suppurativa (HS) is a chronic, inflammatory, skin condition 
characterized by recurrent, painful, draining nodules and abscesses, with 
resultant skin tunneling and scar formation. HS most commonly affects 
intertriginous areas such as the axillae, groin, buttocks, and breasts or 
inframammary region.1 In moderate to severe stages of disease, destruction 
of the normal skin’s architecture leads to the formation of sinus tracts and 
fistulas with dermal and subcutaneous fibrosis.1 It is estimated that 1-4% of 
the population is affected by HS.1  
One of the many challenging aspects that HS patients are faced with on a 
daily basis is wound care. Many HS abscesses and draining nodules and 
tunnels require frequent dressing changes, up to multiple times daily, given 
their high exudative nature.1 Wound care in HS is further complicated by the 
anatomical predilection of HS wounds. Many dressings on the market are 
designed to be placed over flat surfaces, and it is often difficult for HS 
patients to accommodate these flat dressings over the dynamic contours of 
intertriginous areas such as the axillae, groin, and buttocks. 
It is well known that the need for frequent dressing changes due to the 
heavy exudate in some patients and its odor, significantly impacts patient’s 
quality of life.1 However, there currently is no standard wound care protocol 
in place for addressing the wide variety of lesions seen in HS.2 Therefore, 
we have designed a study where we will provide HS patients with different 
types, sizes, and quantities of FDA-cleared dressings, and we will ask them 
to keep a log of which types of dressings they found most useful for their 
wounds. Average as well as maximal pain scores will be measured on a 
numeric scale (NRS). Patient satisfaction, ease of use of dressings, and 
dressing preferences will be measured with a 5-point likert scale. Patients 

will also be asked to log their dressing changes in order to track how often 
dressing changes are needed in HS. HS-PGA, drainage, perceived odor, and 
quality of sleep will be assessed (Table 1).  
We will additionally study how the usage of antimicrobial dressings will 
have an effect on the wound microbiome in order to see how this affects 
healing in the setting of HS. The presence of bacteria in the wound bed will 
be determined by analyzing the collected wound swab samples. Standard 
molecular techniques will be utilized for bacterial analysis. The purpose of 
collecting swab samples is purely qualitative in its intent to gather data on 
bio-bioburden and microbiome composition. Ulcer swab results are not 
indicated for therapeutic treatment nor diagnosis of infection. The results of 
sample swabs will not have an impact on the treatment plan for each 
participant. 
 
3) 
Inclusion and Exclusion Criteria* 
 
Inclusion criteria: 
• Men and women ≥18 years of age  
• Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist  
• Presence of at least one lesion with active drainage 
• Willing and able to provided informed consent 
 
Exclusion criteria: 
• Subjects younger than 18-years-old. 
• Prisoners 
• Pregnant or lactating women 
• Adults unable to consent 
 
 
4) 
Procedures Involved* 
Study duration: 
Each subject will have three visits total over a 6-week period.  
 
Recruitment and procedures: 
Participants recruited for this study will be patients at University of Miami 
Hospital (UMH) outpatient dermatology clinics and wound care centers, who 
present to UMH with a diagnosis of Hidradenitis Suppurativa (HS). During their 
office visit, patients will be invited to participate in a six-week study to determine 
which dressings are best suited for patients with HS.  
 
Potential subjects will be informed of the study during their standard of care 
appointment and then asked if they would like to participate. After signing informed 
consent, a physical exam will be performed and information on the subjects’ 
demographics, and medical history will be collected (visit 0). Quality of life will be 
assessed with DLQI instrument. Maximal and average pain will be assessed on a 5-

point likert scale. Quality of sleep, drainage, and odor will be assessed as well 
(Table 1). Photographs and measurements will be taken of wounds associated with 
HS. Any active wounds will receive standard of care, including cleaning and 
debridement to remove all nonviable soft tissue from the wound by scalpel, tissue 
nippers and/or curettes when appropriate. Wound swab samples will be collected 
from patients from one active wound at each visit. This site will be identified during 
the baseline visit. If debridement is indicated as part of standard care, prior to 
debridement of the wound, a wound swab sample will be collected from the wound 
bed. In circumstances where a layer of nonviable tissue is preventing swab 
collection, the swab sample should be collected during the course of the 
debridement process wherein the wound bed has been exposed. Subjects will be 
provided with a kit that will include 3 types of FDA-cleared dressings ( 1) 
Cutimed® Sorbact® Hydroactive B, 2) Cutimed® Siltec®, and, 3) Sorbion® Sana 
multi-star) that are available on the market and general wound care supplies (i.e. 
tape, gauze) that are also FDA-cleared and available on the market. Dressing 
instructions involve applying desired dressing daily to affected areas and securing 
with tape as needed. Participants may change dressings as needed. Instructions will 
be reviewed with participants upon enrollment. Participating subjects will also be 
given a 2-week log where they will be instructed to fill in which dressings they used 
on which wounds, and how often they changed the dressings. 
 
Subjects will receive weekly phone calls in between follow ups (for a total of 4 
phone calls) by the research team where they will be asked to answer questions on 
average and maximal pain, quality of sleep, drainage and odor. Subjects will be 
asked to follow up in 14 +/- 3 days from visit 0 (visit 1), at which point the physical 
exam will be performed. Maximal and average pain will again be assessed on a 5-
point likert scale. Quality of sleep, drainage, and odor will be assessed as well 
(Table 1). Photographs and measurements of HS wounds will be taken and the 
dressing logs will be collected and evaluated. Wound swab samples will be 
collected from the wound that was pre-identified at baseline visit. Participants will 
share with study personnel which dressings were most useful to them, and this will 
dictate the dressing type that each subject receives for the remaining 4 weeks of the 
study period.  
 
Visit 2 will take place 28 +/- 3 days after visit 1. Subjects will follow up for an 
end of treatment visit where they will have a physical exam. Maximal and average 
pain will again be assessed on a 5-point likert scale. Quality of sleep, drainage, and 
odor will be assessed as well (Table 1). Photographs and measurements of HS 
wounds will be taken. Wound swab samples will be collected from the wound that 
was pre-identified at baseline visit. Subjects’ medical records will be reviewed to 
collect medical history, treatment plans and disease progress. Please see Table 1 
below detailing the schedule of events. 
 
Finally, in order to correlate the above outcomes with independent disease 
progression, HS-PGA score will be calculated at visits 0, 1 and 2. The HS-PGA 
instrument is a 6-point scale used to assess overall disease severity.  HS-PGA will 

be completed at baseline and follow up visits (Table 1). HS affected areas will be 
evaluated and given a numerical score based on presence of abscesses, draining 
fistulas, inflammatory nodules, and non-inflammatory nodules. Then the points are 
added to create one global score. A 2 point reduction and above is considered a 
meaningful clinical response. 
 
Assessments:  
1. Maximal NRS: 
Please rate your pain at its worse over the last 24 hours on the scale below. 
 
 
 
 
 
 
2. Average NRS: 
Please rate your pain on average over the last 24 hours on the scale below. 
 
 
 
 
 
 
3. Drainage assessment: 
How much did your lesion(s) drain during the past 24 hours? 
 
No draining 
A little 
draining 
Moderate 
draining 
A lot of 
draining  
1 
2 
3 
4 
 

 
 
 
 
 
 
 
4. Sleep assessment: 
How much was your sleep disturbed by HS last night? 
 
Not at all 
A little bit 
Moderately 
A great deal 
Unable to 
sleep 
1 
2 
3 
4 
5 
 
 
 
 
5. Odor assessment: 
How would you rate the odor caused by the draining of your lesion(s) during the 
past 24 hours? 
 
No odor 
A little odor 
Moderate odor 
A lot of odor  
1 
2 
3 
4 
 
 
 
6. Dressing’s ease of use assessment: 
How easy to use are your current dressings? 
 
Very Difficult 
Difficult 
Neutral 
Easy 
Very Easy 
1 
2 
3 
4 
5 
 
 
 
7. Dressing satisfaction: 
How satisfied are you with your current dressings? 
 

Strongly 
Dissatisfied 
Dissatisfied 
Neutral 
Satisfied 
Strongly 
Satisfied 
1 
2 
3 
4 
5 
 
 
 
 
 
 
8.  HS-PGA: 
 
 
 
 
 
 

Table 1: Schedule of Events 
 
Baseline 
Visit 
Day 0  
Phone 
call 1 
Day 7 
 
Follow-
Up Visit  
Day 14  
Phone 
call 2 
Day 21 
 
Phone 
call 3 
Day 28 
 
Phone 
call 4 
Day 35 
 
End of 
Treatment 
Visit 
Up to Day 
42 after 
Baseline 
Visit 
Visit Window 
 
7 +/- 3 
Days 
from 
Baseline 
Visit 
14 +/- 3 
Days 
from 
Baseline 
Visit 
7+/- 3 
Days 
from 
Follow-
Up Visit 
14+/- 3 
Days 
from 
Follow-
Up Visit 
21+/- 3 
Days 
from 
Follow-
Up Visit 
28+/- 3 
Days from 
Follow-Up 
Visit 
Visit # 
0 
 
1 
 
 
 
2 
Informed 
Consent/PHI 
authorization 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical HistoryA 
X 
 
 
 
 
 
 
Concomitant 
Medications & 
Procedures 
Assessment 
X 
 
X 
 
 
 
X 
Physical ExamB 
X 
 
X 
 
 
 
X 
Inclusion/Exclusion 
Determination 
X 
 
 
 
 
 
 
Wound(s) 
Photograph 
X 
 
X 
 
 
 
X 
Dermatology Life 
Quality Index 
(DLQI) 
X 
 
 
 
 
 
X 
Average 24 hours 
pain Score (NRS) 
X 
X 
X 
X 
X 
X 
X 
Maximal 24 hours 
pain Score (NRS) 
X 
X 
X 
X 
X 
X 
X 
Review Dressing 
Logs 
 
 
X 
 
 
 
X 
Sleep assessment  
X 
X 
X 
X 
X 
X 
X 
Drainage assessment  
X 
X 
X 
X 
X 
X 
X 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A: Detailed HS history will be gathered, including current wound care regime (types and number of 
dressings utilized per week, including an estimate of anticipated dressings needed per week), exacerbating 
and alleviating factors; B: Hurley staging will be assessed, as well as types (inflammatory, sinus tracts, 
ulcerations), number, and location of lesions 
 
 
5) 
Data and Specimen Banking* 
 
6.1 Collection and Analysis of Wound Swabs 
 
The following study procedures for wound swabs will be performed at the pre-
designated wound sites only. Wound swab samples will be collected at the Baseline 
Visit 0, Follow-Up Visit 1, and Follow-Up Visit 2. 
 
Wound swabs will be collected from all study wounds. If debridement is indicated 
as part of standard care, wound swabs will be performed prior to the debridement 
Wound swab sample will be collected from the wound bed using the Levine 
technique. In circumstances where a layer of nonviable tissue is preventing swab 
collection, the swab sample should be collected during the course of the 
debridement process wherein the wound bed has been exposed. Wound swab 
samples from enrolled subjects will be collected and sent out for further processing 
and analysis to Dr. Irena Pastar’s laboratory. The labels of the tubes will be coded 
to protect the identity of the subjects. Samples will be stored in a -80°C freezer 
prior to shipment to the processing laboratory. Samples will be shipped on dry ice. 
 
6.2 Dressing Logs and Photographs 
 
The dressing logs and photographs collected from each patient will be de-identified 
and stored in a computer located in the Dermatology Research office. The computer 
Dressing 
Satisfaction 
X 
 
X 
 
 
 
X 
Dressings’ Ease of 
Use  
X 
 
X 
 
 
 
X 
Odor assessment  
X 
X 
X 
X 
X 
X 
X 
HS-PGA 
X 
 
X 
 
 
 
X 
Wound Swab 
Sample Collection 
X 
 
X 
 
 
 
X 
Adverse Events 
Assessment 
 
 
X 
 
 
 
X 

is located in a locked room in the University of Miami Hospital West Building, 
Room 506, 1321 NW 14th St, Miami, Fl, 333125.  
 
Statistical analysis will be performed using software already available in the lab. 
This information will be protected in a locked office (see Confidentiality section 
below) and will only be able to be accessed by the primary investigator and the co-
investigators. The photographs will then be downloaded as encrypted, de-identified 
JPEG/TIFF files and stored in the PI computers protected by login and password 
(see section 16). 
 
6) 
Data Management* 
 
The investigator (or research staff) will record the data collected in a manner that 
does not include any direct identifiers of the subject. The investigator will assign a 
code to each subject and link the code to the subject’s identity.  The link to the 
subject’s identity will be maintained on a document separate from the research data.  
Both documents will be stored on password-protected media on a University of 
Miami encrypted device. The data will be stored for at least 3 years after the study 
has concluded and will be destroyed at the earliest opportunity in accordance with 
University of Miami’s policies thereafter. Data will only be accessed by designated 
study team members. 
 
Statistical analysis of collected data will be performed using IBM SPSS Statistics 
for Windows (IBM Corporation, Armonk, NY, USA). Mean and range will be 
calculated for continuous variables. Pearson’s chi-squared test will be used to test 
for independence between categorical variables; for expected values less than 5, 
Fisher’s exact test of independence will be used. 
 
Adverse Events 
7) 
Adverse Events* 
 
8.1 Definition of Adverse events 
 
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable 
and unintended sign [including abnormal laboratory findings], symptom or disease) 
in a subject or clinical investigation subject after providing written informed 
consent for participation in the study. Therefore, an AE may or may not be 
temporally or causally associated with the use of a medicinal (investigational) 
product. In addition, all reports of intentional misuse and abuse of the product are 
also considered an adverse event irrespective if a clinical event has occurred. The 
investigator has the responsibility for managing the safety of individual subject and 
identifying adverse events. Qualified study personnel will be readily available to 
advise on trial related medical questions or problems. The occurrence of adverse 

events must be sought by non-directive questioning of the subject at each visit 
during the study. Adverse events also may be detected when they are volunteered 
by the subject during or between visits or through physical examination findings, 
laboratory test findings, or other assessments. Adverse events must be recorded in 
the Adverse Events eCRF under the signs, symptoms or diagnosis associated with 
them, accompanied by the following information (as far as possible) (if the event is 
serious refer to Section 8.2):  
1. The severity grade.  
• mild: usually transient in nature and generally not interfering with normal 
activities  
• moderate: sufficiently discomforting to interfere with normal activities 
• severe: prevents normal activities  
2. its relationship to the study treatment (suspected: Yes/No). If the event is due to 
lack of efficacy or progression of underlying illness (i.e. progression of the study 
indication), the assessment of causality will usually be ‘Not suspected’. The 
rationale for this guidance is that the symptoms of a lack of efficacy or progression 
of underlying illness are not caused by the trial drug, they happen in spite of its 
administration and/or both lack of efficacy and progression of underlying disease 
can only be evaluated meaningfully by an analysis of cohorts, not on a single 
subject.  
3. its duration (start and end dates) or if the event is ongoing, an outcome of not 
recovered/not resolved must be reported.  
4. whether it constitutes a serious adverse event (SAE - see Section 8.2 for 
definition of SAE) and which seriousness criteria have been met.  
5. action taken regarding with study intervention. 
 
All adverse events must be treated appropriately. Treatment may include one or 
more of the following:  
• study dressing regime not changed  
• study dressing regime interrupted/dressings withdrawn  
 
Conditions that were already present at the time of informed consent should be 
recorded in medical history of the subject. Adverse events (including lab 
abnormalities that constitute AEs) should be described using a diagnosis whenever 
possible, rather than individual underlying signs and symptoms. Adverse event 
monitoring should be continued for at least 10 weeks following the last date of 
study dressing usage. Once an adverse event is detected, it must be followed until 
its resolution or until it is judged to be permanent (e.g. Continuing at the end of the 
study), and assessment must be made at each visit (or more frequently, if necessary) 
of any changes in severity, the suspected relationship to the interventions required 
to treat it, and the outcome. 
 
8.2 Serious adverse events  
 

An SAE is defined as any adverse event [appearance of (or worsening of any pre-
existing)], undesirable sign(s), symptom(s) or medical conditions(s) which meets 
any one of the following criteria:  
• fatal  
• life-threatening. Life-threatening in the context of a SAE refers to a reaction in 
which the subject was at risk of death at the time of the reaction; it does not refer to 
a reaction that hypothetically might have caused death if it were more severe  
• results in persistent or significant disability/incapacity  
• constitutes a congenital anomaly/birth defect  
• requires inpatient hospitalization or prolongation of existing hospitalization, 
unless hospitalization is for:  
• routine treatment or monitoring of the studied indication, not associated 
with any deterioration in condition  
• elective or pre-planned treatment for a pre-existing condition that is 
unrelated to the indication under study and has not worsened since signing 
the informed consent  
• social reasons and respite care in the absence of any deterioration in the 
subject’s general condition  
• treatment on an emergency outpatient basis for an event not fulfilling any 
of the definitions of a SAE given above and not resulting in hospital 
admission  
• is medically significant, e.g. defined as an event that jeopardizes the subject or 
may require medical or surgical intervention to prevent one of the outcomes listed 
above 
 
Medical and scientific judgment should be exercised in deciding whether other 
situations should be considered serious reactions, such as important medical events 
that might not be immediately life threatening or result in death or hospitalization 
but might jeopardize the subject or might require intervention to prevent one of the 
other outcomes listed above. Such events should be considered as “medically 
significant”. Examples of such events are intensive treatment in an emergency room 
or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not 
result in hospitalization or development of dependency or abuse (please refer to the 
ICHE2D Guidelines). 
 
8.3 SAE reporting  
 
To ensure subject safety, every SAE, regardless of causality, occurring after the 
subject has provided informed consent and until 10 weeks following the last 
administration of study dressings must be reported within 24 hours of learning of its 
occurrence.  
 
All follow-up information for the SAE including information on complications, 
progression of the initial SAE and recurrent episodes must be reported as follow-up 
to the original episode within 24 hours of the investigator receiving the follow-up 
information. An SAE occurring at a different time interval or otherwise considered 

completely unrelated to a previously reported one must be reported separately as a 
new event.  
 
If the SAE is not previously documented (new occurrence) and is thought to be 
related to the study treatment, a CMO & PS Department associate may urgently 
require further information from the investigator for health authority reporting.  
 
Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and 
reported to the competent authorities and relevant ethics committees in accordance 
with EU Guidance 2011/C 172/01 or as per national regulatory requirements in 
participating countries. Any SAEs experienced after the 10 week period following 
the last administration of study treatment should only be reported if the investigator 
suspects a causal relationship to study treatment. Any SAEs reported up to the 
subject’s last visit will be reported in the AE eCRF. SAEs beyond that date will 
only be recorded in the Safety database. 
Risks to subjects in this study include contact dermatitis in the skin areas 
exposed to the dressings provided in this study. However, we will be 
utilizing FDA-cleared dressings that are available on the market and 
therefore pose a risk that is no higher than the current risk subjects are 
undertaking while utilizing other dressings over the same skin areas. 
 
8) 
Potential Benefits to Subjects* 
 
Direct benefits to subjects include complimentary access to various high 
quality dressings that they might otherwise not have had access to as they 
may not be covered by insurance for HS. 
 
9) 
Vulnerable Populations* 
 
Pregnant women, prisoners, and children younger than 18 years old are excluded.  
 
10) Setting 
 
Patients will be recruited from outpatient dermatology clinics and wound 
centers at the University of Miami Clinics and Hospital at 1295 NW 14th St, 
Suite K/L/M, Miami, FL 33125. Subjects will be offered follow up at 
outpatient dermatology research offices located at the University of Miami 
Hospital West Building, 1321 NW 14th St., Suite 506, Miami, FL, 33125. 
All of the necessary procedures for the study will take place at this location. 
 

11) Resources Available 
 
Hadar Lev-Tov, M.D., is a dermatologist with expertise in wound healing disorders 
including Hidradenitis Suppurativa; he will be the primary investigator on this 
study. All subjects will be recruited from outpatient dermatology clinics and wound 
centers and he can perform detailed wound and skin evaluations. 
 
All associated study personnel are CITI certified and have extensive data analysis 
training. 
 
12) Prior Approvals 
 
None. 
 
13) Recruitment Methods 
 
Thirty subjects (30) with a diagnosis of Hidradenitis Suppurativa will be 
recruited by the Investigator and study staff. Subjects will be recruited from 
outpatient dermatology clinics and the Wound Care Center at the University 
of Miami. During their standard visit, subjects will be offered the 
opportunity to enroll in the study. If subjects agree to take part in this study, 
study staff will guide subjects through the informed consent process. 
Subjects will be asked to sign the informed consent form and the photo 
consent form before the study procedures begin. Subjects will be given 
ample time to consider the study and all questions will be answered by study 
staff. Subjects will be enrolled from the date of protocol approval for a 12 
months period. 
 
14) Local Number of Subjects 
 
This is a pilot study for which we intend to reach 20 subjects. We anticipate a high 
drop-out rate, and therefore intend to recruit and enroll a total of 30 subjects 
locally. 
 
15) Confidentiality 
 
The camera will be stored in a locked office in 1321 NW 14th St. University of 
Miami Hospital West Building, Suite 506, Miami FL 33125 until the end of the 
recruitment. The collected coded and encrypted images will be stored in the 
computers found at the research office protected by a password. The collected 
coded dressing logs will be stored at the research office in a locked cabinet. Both 
the encrypted images and the dressing logs will be securely stored for at least 3 
years after the research project has concluded. Please see section 7 (‘Data 

Management’) for more details on data coding and storage. Only the primary 
investigator and co-investigators will have access to the images, camera, and 
subject information. 
 
16) Provisions to Protect the Privacy Interests of Subjects 
 
All study records will be stored a password-protected computer, in a 
locked room. A separate datasheet will be created that will tabulate 
patients’ names, MRN, date of birth and assign a subject ID. This subject 
ID will act as a code during the 6 weeks the subject is actively 
participating in the study. A second datasheet will contain only the subject 
ID and study relevant data. This will effectively create a de-identified 
database that will be used for analysis at the end of the study. 
 
17) Consent Process 
 
Consent will be obtained by a member of the study team in writing and will take 
place in outpatient dermatology clinics and wound centers after the subject 
completed their clinic visit.  In the clinic, study staff will guide the subjects through 
the consent process. Study staff will describe the study and the procedures involved 
to the subject and review the potential risks and benefits. The subject will be given 
ample time to consider the study. Once the subject agrees to participate, an 
Informed Consent Form will be signed. 
 

18) Process to Document Consent in Writing 
 
Attached. 
 
NOTE: IT IS UNCLEAR WHETHER YOU WILL NEED A PARTIAL 
WAIVER OF HIPAA FOR RECRUITMENT PURPOSES.  IF YOU 
NEED IT, YOU NEED TO ADD THE FOLLOWING: 
19) Authorization for Use and Disclosure of Protected Health 
Information (HIPAA)  
 
If the research team will access patient medical records or other identifiable health 
information for this research, you must obtain a waiver of the requirement for 
written authorization from the patients to access their medical records.   
 
Confirm that you will destroy or de-identify the information you collect at the 
earliest opportunity. 
  I confirm  
 
Confirm that the information you collect will not be reused or disclosed to any other 
person or entity, except as required by law, for authorized oversight of the research 
study or for other research for which the use or disclosure of PHI is permissible.          
   I confirm   
 
 
References 
1. 
Falola RA, DeFazio MV, Anghel EL, Mitnick CD, Attinger CE, Evans KK. What 
Heals Hidradenitis Suppurativa: Surgery, Immunosuppression, or Both? Plast 
Reconstr Surg. 2016;138(3 Suppl):219S-229S. 
2. Alavi A, Kirsner RS. Local wound care and topical management of hidradenitis 
suppurativa. J Am Acad Dermatol. 2015;73(5 Suppl 1):S55-61.