Clinical trial NCT02805595
Conditions: Hidradenitis Suppurativa
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2016-08-01; Completion date: 2022-11-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Detailed description:
The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.

Arms: arm 1: 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Interventions: intervention 1: 23.4% Hypertonic saline
Intervention descriptions: intervention 1: Saline Injections

Protocol documents:
Prot_SAP_000.pdf: 
NCT Number:  
NCT02805595 
Official Title: 
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa 
Document Type: 
Protocol with Statistical Analysis Plan  
Document Date: 
02/22/2019 


(CCI) Committee on Clinical Investigations 
Page 1 of 9 
 
Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
PART B 
STUDY DESCRIPTION 
 
TITLE OF PROTOCOL 
A Single Center Clinical Trial to Evaluate the Effect of 
Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients with 
Hidradenitis Suppurativa 
Principal Investigator 
Dr. Martina Porter 
 
 
 
B1. 
PURPOSE OF PROTOCOL 
The purpose of the protocol is to evaluate the effect of sclerotherapy on fistula and sinus tract 
evolvement using hypertonic saline injections in fistulas and sinus tracts in subjects with hidradenitis 
suppurativa 
 
 
B2. 
SIGNIFICANCE AND BACKGROUND FOR THE STUDY 
Hidradenitis Suppurativa (HS) is a chronic suppurative disease characterized by firm, tender, 
inflammatory, red nodules that often evolve into fluctuant and malodorous painful abscesses, 
fistulas, and non-healing sores.  Rupture of the lesion, suppuration, formation of sinus tracts and 
scarring frequently occurs. It has been estimated to affect up to 4% of the population, affecting 
women more commonly than men. A study performed in 20071 showed that the disease can cause 
significant morbidity, especially among patients who have an early onset of disease, long duration 
and continuous evolution. Proposed etiologic factors include follicular occlusion, bacterial infection, 
genetics2-4, host defense defects, hormonal influences, cigarette smoking, and irritants. Although the 
current belief is that the primary defect is occlusion of the terminal parts of the follicular 
acroinfundibulum5 and recent genetic information supports this hypothesis,6,7  the apocrine milieu is 
likely to  play a meaningful role in the disease because it primarily affects apocrine gland-containing 
regions such as the axillary, inguinal and perineal areas. Importantly, the disease also responds well 
to complete excision of these apocrine gland-containing sites. While this approach is substantially 
disfiguring, requiring large areas of excision, it also typically results in a cure in the region excised, 
while other areas will remain active.   
In order to classify HS the Hurley classification and the Sartorius scoring system are used, both rely 
on clinical data, which may be inaccurate because of the difficulty in assessing the extensiveness of 
the lesions beneath the skin surface. This can lead to underestimation of severity.8 Ultrasound has 
also been used as a low-invasive and safe method for evaluating the lesions of HS. 
One persistent problem for many patients is the continued presence of draining fistulas and sinus 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
tracts lined with epithelium that can sometimes form “honeycomb network”. Because the tracts are 
lined with epithelium, they are unlikely to close or fill in by themselves. A treatment approach that 
has evolved to manage this persistent problem is sometimes called “unroofing” or “deroofing” in 
which the surface the epithelial track is slit and laid open. As shown in appendix 1, the disadvantage 
of this treatment is the wide area of surgical exposure and morbidity that results.   
Sclerotherapy is a well-known, safe and successful treatment for spider and varicose veins. A 
sclerosant is injected directly into the varicose vein and causes endothelial and vein wall damage, 
which leads to occlusion and ultimately results in fibrosis of the targeted vein. One of the sclerosants 
commonly used in clinical practice is hypertonic saline, which causes dehydration of endothelial cells 
and denaturation of cell surface protein and ultimately causes the vein to collapse and close. 
Hypertonic saline is one of the most popular agents because of lack of allergenicity, low cost and easy 
availability. A downside is that upon injection patients experience more pain, because of stinging, in 
comparison with other sclerosants but complication rates such as ulceration are low. Excision is the 
only reliable way to treat these semi-permanent HS lesions. The less-invasive sclerotherapy 
treatment might be an alternative for this since it can disrupt the epithelial lining and allow for 
wound healing from the inside of the tract to occur.  
We have treated two patients with this as innovative therapy using 0.2-0.4 cc of hypertonic saline 
injected in to a tract. In patient one, we did 2 treatments about 1 month apart with substantial 
reduction in the lumen of the fistula. Patient 2 has been treated once and asked for a second 
treatment.  Patient one had some erythema development near the site about 1 month after 
treatment, which resolved and appeared to be due to concomitant disease outside the treated 
fistula. Both patients, as expected, experienced mild to moderate stinging. 
 
This project was first started at MGH through cede review and are now continuing it at Beth Israel 
Deaconess Medical Center, which will be the only study site.  
 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
 
B3. 
DESCRIPTION OF RESEARCH PROTOCOL 
A. 
Study Design – Overview, Methods, Procedures 
 
 Study Design and plan:  
The design of this study is a single center, single-blinded clinical research treatment study. This clinical 
study will be conducted at Beth Israel Deaconess Medical Center in Boston (the study was previously 
conducted at MGH and is currently being conducted at both institutions through Cede Review with MGH 
as the overseeing IRB and BIDMC). All subjects with a signed informed consent will be screened to 
ensure they meet all inclusion criteria and do not meet the exclusion criteria. After enrolment, the 
duration of the study is approximately 8 weeks, involving 3 or 4 visits. A schematic overview of the main 
procedures during each visit is illustrated in Appendix 2. 
 
The clinical effect of the hypertonic saline treatment will be evaluated with Physician and patients 
Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit 
(baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in 
week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be 
assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS 
Improvement Assessments. Pain and stinging during treatment sessions will be monitored using 
numeric rating scales (NRS). For monitoring quality of life the DLQI will be used. 
 
Prior to performing any study related procedures, the investigator will discuss with each subject the 
nature of the study, its requirements and its restrictions. A written informed consent form will be 
obtained from each participant prior to any procedure. Each subject with a signed informed consent 
form will be screened at the first visit, to ensure all the inclusion criteria are met and none of the 
exclusion criteria. Medical history and demographic information will be taken. Patients will have their 
medication reviewed and undergo a full HS examination, including lesion counts, Hurley staging and 
target site assessment. Target HS area(s) will be digitally photographed and be imaged with ultrasound. 
The duration of the study is approximately 8 weeks, involving a minimum of 3 and a maximum of 4 
visits. In case of an adverse event or disease progression, patients are instructed to call and/or visit the 
clinic. An overview of the exact procedures during each visit can be found in the chart 
 
Study Table (Chart with Study Procedures) 
Activity 
(timeline)  
0 week 
(Baseline) 
2 Week 
4 Week 
Week 8 
Subject 
Information and 
Informed Consent 
 
 
 
 
Eligibility Criteria  
 
 
 
 
Medical History  
 
 
 
 
Prior and 
concomitant 
therapy  
 
 
 
 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
Review and 
document 
pregnancy 
avoidance with 
females of child 
bearing age 
 
 
 
 
23.4% Hypertonic 
Saline Injection 
 
 
 
 
Urine Pregnancy 
Test (For all 
females of 
childbearing age) 
 
 
 
 
Ultrasound (to  
locate the tracts)  
 
 
 
 
 
 
 
B. 
Statistical Considerations 
a. Sample Size Justification:   
The total number of subjects to be studied is 20 and the number to be studied at BIDMC is 14.  
A sample size calculation is not applicable, for this is an early feasibility and tolerability pilot study. 
 
b. Data Analysis:   
 
Primary study parameter(s) 
The clinical efficacy will be measured by Physician and patients Assessments. These are continuous 
variables and depending on the date distribution a one way ANOVA, a Kruskal Wallis or a Wilcoxon 
rank sum test will be performed for analysis. 
Secondary study parameter(s) 
Hence the small patient group in this pilot study, no power is expected from statistical analysis. 
Therefore all outcomes will be assessed by using descriptive statistics. 
The clinical efficacy will also be measured using the following outcomes: 
 
Measuring the length and the lumen of the fistulas using ultrasound if possible. Since this 
variable is highly dependent on investigator and experience with ultrasound, descriptive statistics will 
be used to present this variable. 
The patient reported outcomes: 
 
HS Improvement assessment: this is a continuous variable and depending on the date 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
distribution a one way ANOVA, a Kruskal Wallis or a Wilcoxon rank sum test will be performed for 
analysis. 
 
NRS to assess pain and stinging: continuous variable. Per individual a percentage 
improvement will be calculated as a main outcome.  
 
DLQI: continuous variable. this is a continuous variable and depending on the date 
distribution a one way ANOVA, a Kruskal Wallis or a Wilcoxon rank sum test will be performed for 
analysis. 
 
C. 
Subject Selection 
Patients potentially eligible for this study are at least 18 years of age and have active HS sites with 
fistula(s) or sinus tracts. A total of 20 subjects will be enrolled in the study. Potential patients will be 
assessed for eligibility to participate in this clinical study using the criteria for inclusion and exclusion 
listed below.  
Inclusion Criteria: 
A subject must meet all of the following criteria in order to be eligible to participate in this study: 
1. 
Male or female subjects are at least 18 years of age or older  
2. 
A confirmed diagnosis of HS disease 
3. 
Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts 
 
Exclusion Criteria: 
Eligible subjects will be excluded from participation if they meet any of the following criteria: 
1. 
Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory 
systemic therapy such as prednisone or adalimumab within the prior month. 
2. 
Are currently pregnant or planning to get pregnant during the study. 
3. 
Are participating in another study using an investigational agent or procedure during 
participation in this study.  
4. 
Have any condition that, in the opinion of the investigator, would compromise the well-being 
of the subject or the study. 
Urine Pregnancy Test 
A urine pregnancy test will be performed locally for all females of childbearing potential at the 
Baseline Visit prior to the first dose of study drug and at minimum at monthly intervals (either at 
study visits or at home between scheduled study visits). The results of the monthly at home tests 
must be communicated to the site. More frequent pregnancy tests will be performed throughout the 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
study if required per local/country requirements. 
• If the Baseline urine pregnancy test performed at the site is negative, then dosing with study 
drug may begin. 
• If the Baseline or postbaseline urine pregnancy test performed at the site is positive, dosing 
with study drug must be withheld and a serum pregnancy test is required. The serum 
pregnancy test will be performed by the central laboratory. If the serum pregnancy test is 
negative, study drug may be started or resumed. If the serum pregnancy test is positive, study 
drug must be permanently discontinued. In the event a pregnancy test comes back 
borderline, a repeat test is required (≥ 3 days later). If the repeat serum pregnancy test is: 
o Positive, the subject must be discontinued; 
o Negative, the subject can continue in the trial; 
o Still borderline ≥ 3 days later, this will be considered documentation of continued lack 
of a positive result and the subject can continue in the study (unless prohibited locally) 
in the absence of clinical suspicion of pregnancy and other pathological causes of 
borderline results. 
If time between visits is longer than 1 month, then collect the results of the monthly at home urine 
pregnancy test between scheduled visits. 
 
If during the course of the study a female becomes surgically sterile or postmenopausal and 
complete documentation as described in Protocol Section 5.2 (Contraception Requirements for 
Females) is available, pregnancy testing is no longer required. 
 
A pregnant or breastfeeding female will not be eligible to enter the study or be allowed to continue 
study drug. 
  
B4. 
POSSIBLE BENEFITS 
The potential benefits of this study are that the individual subject’s Hidradenitis Suppurativa caused 
fistulas and sinus tracts might improve with the administration of sclerosants like hypertonic saline. 
 
B5. 
POSSIBLE RISKS AND ANALYSIS OF RISK/BENEFIT RATIO 
Hypertonic saline is as effective as other sclerosants with the advantage of lack of allergenicity and low 
costs. The most common adverse events or risks associated with sclerotherapy using hypertonic saline 
are hyperpigmentation, teleangiectic matting (neovascularization), pain, ulceration and tissue necrosis. 
Other reported less common adverse events include exacerbation of hypertension, necrosis of kidney 
cortex, hemolysis, hematuria, central nervous system disorders, hypernatremia and membranous fat 
necrosis. 
 
When used to treat fistulas or sinus tracts, none of the systemic adverse events are expected to occur. 
The common adverse events can be minimized by adhering to meticulous technique. 
 
Risks listed in ICF are as follows: 
More Common: Stinging, pain in the injected area 
Less Common: Skin Ulceration,  
Rare: Infection  
 


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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
B6. 
RECRUITMENT AND CONSENT PROCEDURES 
Recruitment 
Dermatologists from Beth Israel Deaconess Medical Center will be informed using IRB-approved 
recruitment letters of this study and asked to refer eligible patients to our research unit. These 
letters will explain the purpose of the research, including a brief description of the nature and extent 
of involvement, and the investigator's email and phone number will be included.  A research study 
advertisement will also be posted in the dermatology clinic. 
 
A list of potential subjects will be compiled from Dr. Kimball and Dr. Porter’s patient population using 
ICD codes for HS. These identified patients will be sent recruitment letters informing them of the 
study and to contact one of the doctors if they are interested. 
 
The study will also be placed on TrialX as well as skinstudies.com, craigslist, twitter and BU quickie 
jobs. TrialX will use clinicaltrials.gov information; skinstudies.com, craigslist, twitter and BU quickie 
jobs will use the recruitment flyer and language from the targeted provider email.  
 
We will advertise the study on Twitter as well with the following posting: “Do you have Hidradenitis 
Suppurativa (HS)? You may be eligible to participate in a clinical trial. If you are interested visit our 
website skintudies.com, email us at clears@bidmc.harvard.edu or call at 617-667-5834.”  
 
Consent 
Prior to entering the study, a licensed physician investigator will explain to the potential subject the 
nature of the study, its purpose, procedures, expected duration, and the benefits and risks involved 
in study participation.  The licensed physician will explain the main study. 
 
Subjects will be given the opportunity to ask questions and be informed of their right to study 
withdrawal.  After this explanation and before any study-specific procedures have been performed, 
the potential subject may voluntarily sign and date the informed consent form for the main study, 
thereby giving permission for the subject to enter the study.  
 
Prior to participation in the study, the subject will receive a copy of the signed and dated written 
informed consent form and any other written information provided to the subject. If, for any reason, the 
subject desires more time to consider the decision, the subject will be given a copy of the unsigned 
consent form for reference and instructed to call the office if they decide to participate in the study. 
 
Subject Protection 
In order to address the issue of patients feeling pressured to participate, a standard approach was 
developed and implemented years ago. This gives the patient the opportunity to actively 
demonstrate their interest before enrolling in the study. If a discussion about the study presents 
itself during a clinical encounter, the patient is offered to take the consent home and read and then 
asked to follow up with the clinic if they are interested. It is also attempted to have a physician who 
is not involved in their clinical care go over their consent form in order to provide further separation.  
 


(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
B7. 
STUDY LOCATION 
 Privacy  
Subject visits will be conducted in the CRC at BIDMC or, rarely, in private patient exam rooms in the 
dermatology clinic if the CRC is not available at the time of subject visits.  Both locations should 
ensure adequate privacy for patients.  Patients will complete all study related procedures in these 
private settings, including questionnaires.  Questionnaires will be in written form and returned 
directly to the investigators or study staff. 
 
Pre-screening telephone calls and subject visits will be limited only to the minimum amount of data 
necessary to accomplish the research purposes.  No sensitive questions will be discussed by 
telephone 
 
 Physical Setting 
Subject visits will be conducted in the CRC at BIDMC or, rarely, in private patient exam rooms in the 
dermatology clinic if the CRC is not available at the time of subject visits.  Both locations should 
ensure adequate privacy for patients.  Patients will complete all study related procedures in these 
private settings, including questionnaires. 
 
 
B8. 
DATA SECURITY 
All subjects will be assigned a subject number at their screening visit.  Only investigators and study 
staff at BIDMC will have access to the subject’s identifiable health information. To ensure 
appropriate privacy and confidentiality, any paper source documentation and questionnaires will be 
stored in a locked cabinet.  Only the PI, sub-investigator, and study staff will have access to this 
locked cabinet. This documentation will all be coded.  Subject’s identifiable health information will 
be kept separate from coded documentation.  Any electronic data containing PHI will be stored on a 
password protected computer in a locked office and on a secure server behind the BIDMC firewall.  
The Investigator will maintain adequate records for the study, including resultssource 
documentation, Informed Consent documents, drug dispensing and disposition records, safety 
reports, information regarding participants who discontinued, adverse events, and other pertinent 
data. All essential documents will retained by the Investigators for at least 2 years in a long-term 
storage facility as arranged through the CTO. 
 
B9 
Multi-Site Studies 
 
Is the BIDMC the coordinating site?       
 Yes    
 No  
 
Is the BIDMC PI the lead investigator of the multi-site study?     
 Yes    
 No  
 


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Study Description – Part B 
CCI Form:  9-2015 
                                                                                                                                                                              PI Revision Date:  2/22/19 
 
B10 
Dissemination of Research Results 
Subjects will be thanked for their participation in the study immediately following their last visit.  
Because we are not able to anticipate the final completion date of the study, which may take years, 
and because we are not primarily responsible for analyzing and publishing the data, it will not be 
feasible for investigators to provide results to individual subjects.  Subjects may contact the PI 
following their completion of the study to inquire about the final findings of the study, if available to 
the investigators, at that time. 
 
Planned dissemination of research results may include abstract presentations at dermatology 
conferences and submission of data for publication in academic journals as an original research 
article. 
 

ICF_001.pdf: 
NCT Number:  
NCT02805595 
Official Title: 
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa 
Document Type: 
Informed Consent  
Document Date: 
10/23/2018 


[CCI] Committee on Clinical Investigations 
 
Page 1 of 11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date:9/18/2018     
 
**FOR CCI USE ONLY** 
Approved by the Beth Israel Deaconess Medical Center  
Committee on Clinical Investigations:  
 
Consent Approval Date:   
 
10/23/2018 
 
 
Protocol Number:  
 
 
2018P000600 
   
 
 
 
INFORMED CONSENT FORM TO TAKE PART IN A RESEARCH STUDY 
 
 
SUBJECT’S NAME:        
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to Evaluate the Effect of 
Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR:       Martina Porter, MD 
PROTOCOL NUMBER:       2018P-000600 
 
INTRODUCTION: 
 This is a research study; 
 Your participation is voluntary; 
 A research study includes only people who choose to take part; 
 You may or may not benefit from participating in the study.  However, your participation 
may help others in the future as a result of knowledge gained from the research; 
 You may leave the study at any time; 
 If you choose not to take part, or if you leave the study, your decision will in no way harm 
your relationship with any member of the research team or any other individuals at Beth 
Israel Deaconess Medical Center. 
 
Please read this consent form carefully and ask the investigators or study staff to explain any words or 
information that you do not clearly understand.  Once you read this consent form and understand what 
your participation in this study will involve, you will be asked to sign this form if you wish to take part.  
You will be given a signed copy of the form to keep for your records. 
 
DISCLOSURE OF SPECIAL INTERESTS OF BIDMC AND INVESTIGATORS 
 
This study is being conducted by Dr. Martina Porter and is funded by the Hidradenitis Suppurativa 
Foundation.  The funding agency in this study Hidradenitis Suppurativa Foundation is paying Beth 
Israel Deaconess Medical Center to perform this research.  BIDMC or Dr. Martina Porter have no 
additional interests in this research project. 
 
WHOM TO CONTACT IF YOU HAVE QUESTIONS OR PROBLEMS 
 
If you have any questions, concerns or complaints about this research or experience any problems, 
you should contact Dr. Martina Porter at [617] 667-5834. 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 2 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
 
PURPOSE 
 
We are doing this research study to see, whether injecting a concentrated salt solution (hypertonic 
saline) into the draining tunnels of hidradenitis suppurativa (HS) patients will make them stop 
draining. This same treatment is commonly used to treat varicose veins and is called sclerotherapy. 
We think it also may be effective for treating the draining tunnels. 
 
Hypertonic saline involved in this study is investigational. This particular investigational agent 
(hypertonic saline) has been approved by the U.S. Food and Drug Administration (FDA) in low 
concentrations to treat dehydration but we do not yet known if it is useful or safe as a treatment to 
treat fistulas and sinus tracts in HS patients. Hypertonic saline is not approved by the FDA to treat 
fistulas and sinus tracts in HS patients. 
 
STUDY PARTICIPANTS 
You have been asked to be in the study because you have HS with fistula(s)/sinus tracts. 
 
Approximately 20 people will take part in this study at Beth Israel Deaconess Medical Center.   
 
DESCRIPTION OF STUDY DETAILS 
 
If you agree to be in this study, you will be asked to read and sign this consent form.  After you sign the 
consent form, the following things will happen: 
 
Visit 1 
This visit will take about 45 minutes. At this visit, we will: 
 Test your urine for pregnancy, if you are a female able to become pregnant. Pregnant women 
can't take part in this research study. 
 Take your medical history, including any medications you are currently taking or have taken in 
the past. You will need to tell the study doctor about all medications or therapies you have 
used for your HS in the past, even if you are not using them now. 
 Examine and grade your HS. 
 Ask you to fill out questionnaires about your HS and how it affects your life. 
 Take photos of your HS. 
 We will take pictures of your HS site.  
 Perform ultrasound of your HS sites to determine presence of fistula(s). An ultrasound scan 
makes pictures of the body using sound waves. You will lie on a table. The operator will put a 
gel on your skin so the probe can make good contact. Then the operator will place the probe on your 
skin and will move it back and forth. The probe is like a hand-held microphone. The scan will 
take about 5-10 minutes. 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 3 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
 One site with fistula(s) is injected with Hypertonic Saline and ask you to fill out a pain/stinging 
questionnaire. 
 
Visit 2 and 3: 
 
This visit will take about 30 minutes. The visit will take place about 2 weeks after Visit 1. At this visit, 
we will: 
 Test your urine for pregnancy 
 Ask you about any changes in your health and medications since your last visit. 
 Examine and grade your HS 
 Ask you to fill out questionnaires about your HS and how it affects your life. 
 Take photos of your HS. 
 
You’ll receive another injection with Hypertonic Saline in the fistula(s) identified at first visit and ask 
you to fill out a pain/stinging questionnaire. 
 
Ask you and the physician to assess the treated areas. 
 
Visit 4 
This visit will take about 30 minutes. The visit will take place about 8 weeks after Visit 1. At this visit, 
we will: 
 Ask you about any changes in your health and medications since your last visit. 
 Examine and grade your HS 
 Ask you to fill out questionnaires about your HS and how it affects your life. 
 Take photos of your HS. 
 Perform ultrasound of treated HS areas. 
 Ask you and the physician to assess the treated areas. 
 
After You Complete the Study 
After you complete the study, we will refer you back to your own doctor for your ongoing medical 
care. 
 
Stopping the Study Early 
If you decide to stop taking part in the study for any reason, we will ask you to make a final study 
visit. The final study visit will take about 30 minutes. At this visit, we will: 
 Examine and grade your HS 
 Perform ultrasound of the treated areas 
 Ask you about any side effects or health problems since your last visit 
 Ask you to fill out some questionnaires 
 
RISKS AND DISCOMFORTS 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 4 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
 
As a result of your participation in this study, you are at risk for side effects listed in this section.  
You should discuss these with the investigator and with your regular doctor if you choose. 
 
More Common: The most common side effect is pain and/or stinging upon injection of the 
hypertonic saline into the fistula tract. It may last for a period of time after the procedure but this 
discomfort should then resolve on its own. 
 
Less Common:  While uncommon it is possible that the injection will result in Skin Ulceration. 
Ulceration is a side effect seen when sclerotherapy is used for varicose veins. The skin may become 
discolored and/or  the top layer of the skin may break down. This can be treated with local wound 
care including bandaging the area and keeping it clean. 
 
Rare: A rare side effect is that the injection could lead to Infection as this is a procedure that 
involves inserting a needle and medication (hypertonic saline) into the skin. We will take steps to 
minimize this risk including using sterile needles and cleaning the affected area with an alcohol wipe 
prior to the procedure.  
 
There may be other risks of hypertonic saline that are currently unknown. 
 
If you are pregnant or become pregnant, this treatment may involve risks to the embryo or fetus 
which are currently unforeseeable. 
 
PREGNANCY 
 
Because of the effects of this study medication on the developing fetus is not known, you may not participate 
in this study if you are pregnant. You will be required to take a pregnancy test to verify that you are not 
pregnant before receiving your first dose of the study medication. 
 
For the duration of the study, if you are engaged in sexual activity that could cause you or your partner(s) to 
become pregnant, you and your partner(s) must agree to use a highly effective method of birth control or 
abstain from sexual activity that could cause you or your partner(s) to become pregnant  
 
The methods of highly effective birth control for this study are below: 
1. Contraceptive implant, such as Nexplanon or Implanon 
2. Levonorgestrel or copper intrauterine device (IUD), such as Mirena, Skyla, ParaGard or Liletta 
3. Permanent female sterilization, such as tubal ligation or Essure with confirmed tubal occlusion 
4. Male partner(s) has had a vasectomy more than three months before study enrollment 
5. Oral contraceptives pill, patch or ring 
6. Injectable contraception, such as Depo Provera 
7. Consistent use of a barrier method, such as diaphragm with spermicide or condoms 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 5 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
 
If you believe you have become pregnant while participating in this study, you must inform your study doctor 
immediately.   
 
Other Risks Related to Study Procedures 
 
ULTRASOUND 
An ultrasound will be performed. There is no known radiation risks associated with standard ultrasound 
procedures. For this study the Philips Lumify Ultrasound Device will be used.  You may experience mild pain 
from ultrasound examination of your lesions. 
 
LOSS OF CONFIDENTIALITY 
There is the potential for loss of confidentiality by participating in this study.  Every effort will be 
made to protect the confidentiality of your identifiable information.   
 
 
MEDICAL RECORD 
 
A copy of this consent form and information collected during this research may become part of your 
medical record, if the information is  relevant to the care you receive at Beth Israel Deaconess 
Medical Center.  Medical records are considered permanent records; therefore, information cannot 
be deleted from the record.  Medical records are available to health care professionals at Beth Israel 
Deaconess Medical Center and may be reviewed by staff when carrying out their responsibilities, as 
well as by external parties such as health care insurers and others in certain circumstances.  If you 
are not currently a patient at Beth Israel Deaconess Medical Center  and do not have a medical 
record at Beth Israel Deaconess Medical Center, one may be created for you for your participation in 
this research.  You may also be required to register as a patient of Beth Israel Deaconess Medical 
Center in order to participate in this research. 
 
 
POSSIBLE BENEFITS 
 
It is not possible to predict whether you will benefit directly from participation in this study.  However, 
your participation may help others in the future as a result of knowledge gained from the research. 
 
OTHER AVAILABLE OPTIONS 
Taking part in this study is voluntary.  Instead of being in this study, you have the following options: 
 Injection with intralesional steroids (kenalog) 
 Surgical excision 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 6 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
Hypertonic Saline has not been approved by the FDA for treatment of your condition, however, 
many doctors in the community commonly prescribe the drug to treat varicose veins.  Please be 
aware that not all doctors may agree to prescribe this drug for you, and that not all health insurance 
companies will pay for the drug when it is prescribed for varicose veins or hidradenitis suppurativa. 
 
This research study is not meant to diagnose or treat medical problems.  Participation in this 
research study does not take the place of routine physical examinations or visits to your regular 
doctor. 
 
We recommend that you discuss these and other options with the investigator and your regular 
doctor so that you can make a well-informed decision about participating in this study. 
 
IF YOU DECIDE NOT TO TAKE PART IN THE STUDY 
 
Participation in this study is voluntary.  You have the right to decide not to take part in this study.  If 
you choose to participate, you have the right to leave the study at any time. Your decision to not 
participate will not result in any penalties or loss of benefits to you. The investigators will tell you 
about new information that may affect your willingness to stay in this study.  
 
If you decide not to participate in the study or decide to leave the study early, your decision will not 
affect your relationship with the research team or any other individual at Beth Israel Deaconess 
Medical Center.   
 
INVESTIGATORS RIGHT TO STOP THE STUDY 
 
The investigators have the right to end your participation in this study if they determine that you no 
longer qualify to take part, or if it would be dangerous for you to continue, or if you do not follow 
study procedures as directed by the investigators.  Beth Israel Deaconess Medical Center or the 
funding source may stop the study at any time. 
 
COSTS AND/OR PAYMENTS TO YOU 
 
COSTS COVERED BY STUDY 
You will not be charged for tests, procedures, medications that are part of this research study.   
 
PAYMENTS TO YOU: 
 
It may take up to 8 weeks for you to receive payment by check. 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 7 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
Any payments made to you may be taxable income to you. This does not include any payments you 
may receive to reimburse (pay you back) you for certain expenses like parking fees or travel.  We 
are required to obtain your name and social security number for preparation and submission of 
Internal Revenue Service (IRS) Form 1099-Misc.  You may receive an Internal Revenue Service 
Form 1099 from BIDMC if you receive more than $600 or more in one calendar year for taking part 
in one or more research studies at BIDMC.  Questions about your own tax status should be referred 
to your personal tax advisor. 
 
You will be paid for the following: $25 per study visit if you qualify for the study.   
 
COST OF RESEARCH RELATED INJURY: 
 
If you are injured as a direct result of your participation in this study you should contact the 
Investigator at the number provided under the section “Whom to Call if You Have Questions” in this 
form.  You will be offered the necessary care to treat your injury.  You or your insurance company 
will be billed for medical care and/or hospitalization related to this injury.  You will be responsible for 
all co-payments and deductibles required under your insurance.  BIDMC will consider 
reimbursement of injury related expenses not covered by your insurance on a case-by-case basis.  
At this time there is no plan to reimburse you for items such as lost wages or lost time from work.  
By signing this consent form you have not given up any legal rights. 
 
OTHER IMPORTANT INFORMATION  
 
A description of this clinical trial will be available on www.ClinicalTrials.gov as required by U.S. law.  
This Web site will not include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
 
 
AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR PROTECTED HEALTH 
INFORMATION 
As part of this study, we will be collecting, using and sharing with others information about you.  
Please review this section carefully as it contains information about the federal privacy rules and the 
use and disclosure of your information.   
 
PROTECTED HEALTH INFORMATION [PHI] 
By signing this informed consent document, you are allowing the investigators and other authorized 
personnel to use [internally at BIDMC] and disclose [to people and organizations outside the BIDMC 
workforce identified in this consent] health information about you.  This may include information 
about you that already exists (for example: your medical records and other sources of health 
information, demographic information, the results of any laboratory tests, and mental health records 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 8 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
if applicable as well as any new information generated as part of this study.  This is your Protected 
Health Information. 
 
PEOPLE/GROUPS AT BIDMC WHO WILL SHARE AND USE YOUR PROTECTED HEALTH INFORMATION 
Your Protected Health Information may be shared with and used by investigators working on this 
study, including the supporting research team (such as research assistants and coordinators, 
statisticians, data managers, laboratory personnel, pharmacy personnel, and administrative 
assistants), and may also be shared and used by other health care providers at BIDMC who have 
treated you in the past and have information relevant to the research, or who provide services to you 
in connection with the research.  Your Protected Health Information may also be shared with the 
members and staff of the Committee on Clinical Investigations of Beth Israel Deaconess Medical 
Center, which is responsible for reviewing studies for the protection of the research subjects.  
 
PEOPLE/GROUPS OUTSIDE OF BIDMC WITH WHOM YOUR PROTECTED HEALTH INFORMATION WILL BE 
SHARED 
We will take care to maintain confidentiality and privacy about you and your Protected Health 
Information.  We may share your Protected Health Information with the following groups so that they 
may carry out their duties related to this study: 
 
 The other hospitals and medical centers taking part in this study and research collaborators 
at those institutions 
 Any external health care providers who provide services to you in connection with this 
research 
 Laboratories not affiliated with BIDMC that are involved in conducting tests related to the 
research 
 Statisticians and other data monitors not affiliated with BIDMC 
 The members and staff of any other IRBs (beyond the BIDMC Committee on Clinical 
Investigations) that oversee the research  
 Centralized data collectors  
 Your health insurance company 
 The Food and Drug Administration [FDA], the Department of Health and Human Services 
[DHHS], the National Institute of Health [NIH], the Office for Human Research Protections 
[OHRP], and other federal and state agencies that may have jurisdiction over the research 
 Hospital and Clinical Research Accrediting Agencies 
 Data and Safety Monitoring boards that oversee this study (if applicable) 
 
Those who receive your Protected Health Information during the course of the research may not be 
required by the federal privacy regulations to protect it, and they may make further disclosures to 
others and use your information without being subject to penalties under those laws.   
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 9 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
WHY WE ARE USING AND SHARING YOUR PROTECTED HEALTH INFORMATION 
The main reason for using and sharing your Protected Health Information is to conduct and oversee 
the research as described in this Informed Consent Document.  There are many other reasons 
beyond the research for which BIDMC may use or disclose your Protected Health Information.  Not 
all of these reasons require your express written authorization.  For example, we will use and share 
your Protected Health Information to ensure that the research meets legal, institutional and 
accreditation requirements and to conduct public health activities.  The various ways in which 
BIDMC may use and disclose your protected health information without your authorization are 
explained in a document called the Notice of Privacy Practices.  If you have not received a copy of 
BIDMC’s Notice of Privacy Practices, please ask us for one and review it before signing this form.  In 
addition to signing this document, you may also be asked to sign a BIDMC General Agreement form 
acknowledging that you have received the BIDMC Notice of Privacy Practices.   
 
NO EXPIRATION DATE – RIGHT TO WITHDRAW AUTHORIZATION 
Your authorization for the use and disclosure of your Protected Health Information in this Study shall 
never expire.  However, you may withdraw your authorization for the use and disclosure of your 
Protected Health Information at any time provided you notify the Principal Investigator in writing.  If 
you would like to take back your authorization so that your Protected Health Information can no 
longer be used in this study, please send a letter notifying the Principal Investigator of your 
withdrawal of your authorization to Dr. Martina Porter at 330 Brookline Ave., Boston, MA  02215. 
Please be aware that the investigators in this study will not be required to destroy or retrieve any of 
your Protected Health Information that has already been used or disclosed before the Principal 
Investigator receives your letter, and they are permitted to continue to use and disclose your 
previously collected information as necessary to complete the research. 
 
REFUSAL TO SIGN 
Your clinical treatment may not be conditioned upon whether you sign the Authorization for 
Research. However, if you choose not to sign this informed consent document and authorization for 
the use and disclosure of your Protected Health Information, you will not be allowed to take part in 
the research study. 
 
RIGHT TO ACCESS AND COPY YOUR PHI 
If you wish to review or copy your Protected Health Information as it is made part of your medical 
record, you may do so after the completion or termination of the study by sending a letter to the 
Principal Investigator requesting a copy of your Protected Health Information.  You may not be 
allowed to inspect or copy your Protected Health Information until this study is completed or 
terminated. 
 
ADDITIONAL CONTACT FOR QUESTIONS OR CONCERNS 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 10 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
You may contact the Human Subjects Protection Office at [617] 975-8500 in the event that you 
would like to obtain information or to offer input about the research study.   This office is 
independent of the investigator or investigator’s research staff and can also assist with questions 
relating to your rights as a participant in research, which may include questions, concerns or 
complaints about your participation in the study. 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019


[CCI] Committee on Clinical Investigations 
Page 11 of 11 
 
SUBJECT'S NAME: 
TITLE OF RESEARCH PROTOCOL: A Single Center Clinical Trial to 
Evaluate the Effect of Sclerotherapy on Fistulas and Sinus 
Tracts in Adult Patients with Hidradenitis Suppurativa 
PRINCIPAL INVESTIGATOR'S NAME: Martina Porter, MD 
PROTOCOL #: 2018P-000600 
 
Informed Consent – Part D 
CCI Form: 4-2018 
PI Revision Date: 9/18/2018   
 
THE FOLLOWING PARAGRAPHS CONTAIN SOME STANDARD INFORMATION WHICH 
GENERALLY APPLIES TO INDIVIDUALS PARTICIPATING IN A RESEARCH STUDY. 
 
CONSENT FORM FOR CLINICAL RESEARCH 
I have read the previous page[s] of the consent form and the investigator has explained the details of the 
study.  I understand that I am free to ask additional questions. 
 
If I wish additional information regarding this research and my rights as a research subject, or if I believe I 
have been harmed by this study, I may contact the Human Subjects Protection Office (HSPO). 
 
I am aware that this is a research project and that unforeseen side effects may occur. 
 
I understand that the Beth Israel Deaconess Medical Center has no formal program for compensating 
patients for medical injuries arising from this research.  Medical treatment will be provided for injuries at the 
usual charge to me or to my insurer unless payment is otherwise provided for in this consent form. 
 
I understand that participation in this study is voluntary and I may refuse to participate or may discontinue 
participation at any time without penalty, loss of benefits, or prejudice to the quality of care which I will 
receive. 
 
I acknowledge that no guarantees have been made to me regarding the results of the treatment involved in 
this study, and I consent to participate in the study and have been given a copy of this form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Subject or 
 
 
 
 
Date 
Legally Authorized Representative   
(Parent if the subject is a minor) 
 
 
 
 
 
 
 
 
 
 
 
 
Relationship of Legally Authorized Representative to Subject   
 
 
The subject has been given the opportunity to read this consent form and to ask questions before signing, and 
has been given a copy. 
 
___________________________________________________________ 
SIGNATURE OF INVESTIGATOR/Co-Investigator   
DATE 
 
__________________________________________________________ 
PRINT INVESTIGATOR’S/Co-Investigator’s  
NAME 
A signing co-investigator must be listed on the study’s approved Research Staffing Form at the time of consent. 
 
 
COMMITTEE ON CLINICAL INVESTIGATIONS 
APPROVAL EXPIRATION DATE 
 
10/14/2019