Pilonidal Disease Laser Depilation Pilot Study
Phase: NA
Conditions: Pilonidal Disease
Sponsor: Peter Minneci

Protocol 
 
Laser hair depilation in adolescents with 
pilonidal disease, a pilot study and randomized 
control trial  
 
 
 
 
 
 
 
 
 
An investigator-initiated study at Nationwide Children’s Hospital 
 
Principal Investigators: 
 
Katherine Deans, MD, MHSc. 
Assistant Professor of Surgery 
Co-Director, Center for Surgical Outcomes Research 
Division of Pediatric Surgery 
Nationwide Children's Hospital, Columbus, OH  43205 
 
Peter Minneci, MD, MHSc. 
Assistant Professor of Surgery 
Co-Director, Center for Surgical Outcomes Research 
Division of Pediatric Surgery 
Nationwide Children's Hospital, Columbus, OH  43205 
 
 
 
 
 
 
 
 
 
 
 
 
 
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TABLE OF CONTENTS 
 
Table of Contents 
 
 
 
 
 
 
 
 
 
1. Background Information and Rationale 
 
1.1. Introduction 
 
1.2. Relevant Literature and Data 
 
2. Study Objectives 
 
2.1. Primary Objective 
 
2.2. Secondary Objective 
 
3. Investigational Plan 
 
3.1. Study Design 
 
3.2. Study Duration and Enrollment 
 
 
3.2.1. Duration of Study and Enrollment 
 
 
3.2.2. Total Number of Subjects Projected and Site 
 
3.3. Study Population 
 
 
3.3.1. Inclusion Criteria 
 
 
3.3.2. Exclusion Criteria 
 
4. Study Procedures:  
 
 
Phase One: Pilot Study  
 
Phase Two: Randomized Control Trial  
 
4.1 Laser Depilation 
 
4.2 Chemical/Mechanical Depilation 
 
 
4.3 Topical Anesthetic 
 
5. Statistical Considerations 
 
5.1. Primary and Secondary Endpoints 
 
5.2. Statistical Methods 
 
5.3. Sample Size and Power 
 
6. Study Administration 
 
6.1. Data Collection and Management 
 
6.2. Regulatory and Ethical Considerations 
 
 
6.2.1. Risk Assessment 
 
 
6.2.2. Potential Benefits of Trial Participation 
 
 
6.2.3. Risk-Benefit Assessment 
 
6.3 Recruitment Strategy 
 
6.4. Informed Consent/Assent 
 
6.5. Payment to Subjects/Families 
 
6.6. Confidentiality 
 
7. References 
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1. Background Information and Rationale 
 
1.1 Introduction 
 
Pilonidal disease is a common problem among adolescents and young adults. It affects 26 per 
100,000 people with an incidence of 1.1%.1,5 It is characterized by the development of 
epithelialized tracks and sinuses within the natal cleft extending up to the level of the coccyx 
posteriorly (the area between  the buttocks and posterior to the anus). Entrapped hair follicles 
become infected resulting in acute and chronic wounds and draining sinuses that can incur both 
short term and long term morbidity, disability, and poor quality of life.2 The most often seen 
initial presentation is that of a painful mass in the sacrococcygeal region.7 Initial treatment is 
usually with antibiotics and/or surgical incision and drainage of the inflamed and often infected 
cystic cavity. Recurrence rates have been conservatively reported at 16% and as high as 30% in 
some patient populations.2,3 
 
The morbidity of this disease is very significant. Patients, usually in their adolescence and young 
adulthood, may endure chronic pain/inflammation, drainage of sinus tracts associated with 
significant odor, and occasional negative-pressure wound VAC dressings which are 
cumbersome. When disease is active, these patients must lay prone at all times when attempting 
to sleep and are unable to sit due to their wounds; patients with recurrent disease report losing 
months to years of school and work obligations related to the treatment and chronic nature of 
their wounds as well as the emotional toll related to an embarrassing problem in a sensitive body 
area. This disease remains a source of frustration for patients and their families; they desire a 
durable treatment. 
 
For patients with recurrent disease, there are both medical and surgical methods to treat and/or 
palliate pilonidal disease. Each of these methods incurs a different risk-benefit profile and has 
been associated with significant morbidity.  Overall, surgical methods appear to be more durable 
with long term success rates ranging from 84 to 89% However, surgical excision and 
reconstruction of this area can be associated with significant morbidity and cost. Recurrence 
rates of pilonidal disease after resection have been reported to be 11%, respectively.2,3 
Furthermore, wound issues after resection with primary closure have been reported to be as high 
as 30%.4  Medical therapy is largely dependent upon continued lifelong hair removal either from 
shaving or chemical depilation, meticulous hygiene to the area, and recurrent courses of 
antibiotics with intermittent need for both office-based, and operating room incision and 
drainage procedures. This approach to pilonidal disease incurs a chronicity that can lead to 
longer term disability and reduced quality of life. In fact, the presence of pilonidal disease and its 
complications is an accepted indication for Disability Insurance qualification.6 It has been noted 
by several authors that an optimal treatment for pilonidal disease has yet to be identified.2,3 
 
A small number of studies indicate that laser hair depilation of the natal cleft appears to be 
protective for pilonidal disease recurrence.4 Due to this limited data, the mechanism of this 
disease, and the absence of randomized controlled data in the alternative treatment modalities of 
pilonidal disease, we believe that laser depilation should be studied as a first line therapy. The 
goal of this study is to: 1) assess the safety and patient tolerance of laser depilation through a 
single arm pilot study, and 2) determine the efficacy of this treatment in a single center 
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randomized controlled trial comparing laser depilation to standard of care in pediatric patients 
with pilonidal disease. 
 
1.2 Relevant Literature and Data 
 
Surgical Management of Pilonidal Disease: Studies related to the surgical management of 
pilonidal disease have largely focused on the technical aspects of resection and reconstruction. 
Over one hundred studies in the literature have reported various methods for managing this 
disease, but with inconsistent methodology and consistently unsatisfactory outcomes. The ideal 
operation for pilonidal disease should eradicate the disease, minimize recurrence, and carry low 
morbidity and disability. Incision and drainage has been the primary treatment in cases of acute 
presentation. After incision and drainage overall successful healing has been reported to be 
approximately 60%, whereas the remaining patients required an additional excision procedure 
before closure of these wounds. For patients with recurrent disease, wide local excision with 
primary or secondary closure, with consideration of off-midline closure, has been widely 
advocated. However, wide local excision in this body region is associated with significant 
morbidity including a post-operative wound complication rate of 30%. Marsupialization for 
pilonidal disease entails incising the sinus tracts without excision of normal tissue resulting in 
smaller wounds, limited tissue trauma, and shorter recovery.8 However, reported duration of 
healing and durability has been variable.  
 
Medical Management of Pilonidal Disease: Standard medical management of pilonidal disease 
utilizes hair depilation and local wound care with intermittent antibiotic administration for flares.  
 
Phenol solutions have also been tried in an attempt to sclerose sinus tracts. This involves one or 
more injections into the affected chronic sinus tracts until filled, removal of sinus hairs and 
debris with forceps, as well as local shaving. Smaller prospective series have demonstrated 
success rates ranging from 60% to 95%.9-12 In cases of recurrent chronic sinus disease, phenol 
injection and local depilatory cream application on a weekly basis have shown low subsequent 
recurrence rates (0%–11%) at extended follow-up.13 In chemical depilatory creams, common 
active ingredients are calcium thioglycolate or potassium thioglycolate, which breaks down the 
disulfide bonds in keratin and weakens the hair so that it is easily scraped off where it emerges 
from the hair follicle. The hair follicle does remain with hair regrowth noted in 2 to 5 days and 
there can be some local skin irritation on the site of application. Some studies have explored the 
utility of certain skin glues to close the chronic tracts associated with chronic pilonidal disease. 
One such study utilized Fibrin glue been injected into these chronic tracts after simple curettage 
with some positive effect.14 Overall, studies of sclerosing agents and glue have yielded variable 
results with limited long term efficacy.  
 
Laser Depilation in Pilonidal Disease: In several retrospective studies and small prospective 
studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent 
infections and decrease the need for repeat surgery in adults and older adolescents. Lukish et al 
published a retrospective review of twenty-eight teenage patients with pilonidal disease who 
underwent initial surgical excision of their presenting abscess. Laser depilation was found to be 
well tolerated with only one patient presenting with recurrent disease after a mean follow up of 
24 months.4 Landa et al determined that their series of 6 patients with recurrent pilonidal disease 
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saw progressive resolution of folliculitis after 3 to 11 treatments with no need for recurrent 
excision. No complications or recurrence were reported.17 Schulze et al reported their experience 
of eighteen men and five women treated with laser depilation from 2001 to 2004. All patients 
had experienced recurrent folliculitis and had undergone some form of drainage procedure or 
prior excision. After surgical excision of the affected area, a Vasculite Plus laser was used for the 
depilation treatments. Each session involved 9 to 12 treatments and the patients underwent an 
average of two sessions. All 19 of the patients that remain in follow-up report no recurrence of 
their folliculitis or need for further surgical procedures.16 These studies show a positive effect 
with laser depilation in combating recurrent disease. However, there remains a paucity of 
prospective controlled studies related to this treatment modality with minimal data reported on 
the effectiveness of laser depilation in children with pilonidal disease. A prospective study of 
laser hair removal in pediatric patients to assess safety and generate estimates of effectiveness is 
warranted.15-17  
 
2. Study Objectives 
 
2.1 Primary Objective 
 
This is a two-phase study: 
(1) Phase One: Determine the safety and tolerance of laser hair depilation of the natal cleft in 
adolescents with pilonidal disease.  
(2) Phase Two: Perform a randomized controlled trial of laser hair depilation + 
chemical/mechanical depilation versus chemical/mechanical depilation only to determine 
outcomes related to recurrence. Recurrence is defined as a new development of pilonidal 
abscess, folliculitis, or draining sinus after treatment which would require antibiotic 
treatment, additional surgical incision and drainage or excision.  
 
2.2 Secondary Objective 
 
The secondary objective is to compare adverse outcomes, length of stay, days to return to school 
or work, costs of care and quality of life measures between those that receive laser hair 
depilation and those that receive mechanical/chemical hair depilation and hygiene 
recommendations. 
 
3. Investigational Plan 
 
3.1 Study Design 
 
This is a prospective, randomized single-site trial measuring the safety and feasibility of treating 
children (12-20 years old) with pilonidal disease using laser hair depilation. There will be two 
cohorts; those who receive laser hair depilation treatments and those that receive only 
chemical/mechanical depilation. There will be two phases: Phase One – Pilot study to measure 
safety and tolerance and Phase Two – Randomized control trial to determine efficacy as a 
treatment of pilonidal disease and as a possible treatment to intervene on future recurrence.  
 
 
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Enrollment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization: 
 
 
 
 
 
 
Treatment: 
 
 
 
 
 
 
 
Follow-up: 
Any patient age 12-20 years old with history of 
pilonidal disease +/- incision/drainage or previous 
surgical excision procedure 
Surgical clinic evaluation and informed consent 
Does not consent
Randomization 
Surgical clinic or telephone follow up once 
monthly for one year to assess for tolerance 
(traditional pain scale 1-10), resolution, 
recurrence of cellulitis or abscess, or 
development of chronic sinus requiring surgical 
excision 
Assess eligibility with inclusion criteria:  
• 
English and non-English speaking patients 
• 
Pilonidal disease 
• 
All Fitzpatrick skin types 
• 
Age : 12-20 years 
Does not meet inclusion 
criteria 
Chemical depilation (cream application as 
directed) or Mechanical depilation (via shaving) 
Placebo Group  
Laser hair depilation (1 treatment every 4-6 
weeks for a total of 5 treatments) 
Each Treatment: Application of 23% 
lidocane cream to natal cleft for 45 minutes 
prior to simulated laser therapy (no actual 
treatment) 
Intervention Group 
Laser hair depilation (1 treatment every 4-6 
weeks for a total of 5 treatments) 
Each Treatment: Application of 23% 
lidocane cream to natal cleft for 45 minutes 
prior to laser therapy 
810 nm or Nd:YAG 28 joule application at 
auto pulse duration for 400 ms 
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3.2 Study Duration and Enrollment 
 
3.2.1 Duration of Study and Enrollment 
 
Each patient will be involved in the study for one year. Patients will be brought into Surgery 
clinic for 1 treatment every 4-6 weeks to obtain a total of 5 treatments. Follow up will occur 
monthly for one year from the time of initial treatment as we evaluate for tolerance and efficacy.  
 
3.2.2. Total Number of Subjects Projected and Site 
 
A total of 10 children are projected to be enrolled in the first phase of this pilot study. A total of 
164 patients are to be enrolled in the second phase of this study. The study will be conducted at 
Nationwide Children’s Hospital (NCH). Study participants will be recruited in Surgery clinic. 
 
Follow-up research visits will be conducted either by phone, at the Surgery clinic of Nationwide 
Children’s Hospital (NCH), or at the Center for Surgical Outcomes Research (CSOR) within the 
Center for Innovation in Pediatric Practice (CIPP) at the Research Institute at Nationwide 
Children’s Hospital (RINCH).  
 
3.3. Study Population 
 
Children between the ages of 12-20 who are diagnosed with pilonidal disease will be screened 
for eligibility.  
 
3.3.1 Inclusion Criteria 
 
• English and non-English speaking patients 
• All Fitzpatrick skin types 
• Age : 12-20 years 
• Diagnosis of pilonidal disease 
 
 
3.3.2 Exclusion Criteria 
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• History of photosensitivity  
• Actively inflamed pilonidal sinus  
 
4. Study Procedures 
 
Screening and Enrollment 
 
During initial contact with a potential subject, a physician-member of the surgical clinic team 
will assess their eligibility through satisfaction of both inclusion and exclusion criteria. If all 
eligibility criteria are met, a physician-member of the research team will invite the child and 
legal guardian to enroll. The physician-member of the research team will then review the written 
information about the study and answer any questions.  
 
Upon enrollment, study staff will be contacted by the physician-member of the research team 
who obtained consent/assent. The study staff will then conduct all data collection throughout the 
study.  
 
Study Procedures: Laser Hair Depilation Group 
 
Treatment Algorithm 
Laser group: Once randomized to the laser depilation arm, patients will be brought into 
Surgery clinic for 1 treatment every 4-6 weeks to obtain a total of 5 treatments. The treatment 
will consist of an 810 nm (for Fitzpatrick skin types I-IV) or Nd:YAG (for Fitzpatric skin 
types V-VI) 28 joule application at auto pulse duration for 400 ms as based on Fitzpatrick 
skin type classification to be assessed prior to the first treatment visit and confirmed by the 
trained laser technician. A cooling platform and application of 23% lidocaine cream applied 
45 minutes from the treatment will minimize any discomfort associated with the heat of the 
laser treatments. 
 
Control group: They will also arrive at the surgery clinic to have this body area shaved and 
will receive an application of 23% lidocaine cream applied 45 minutes before their simulated 
laser treatment. They will then receive a simulated laser treatment in which the laser is 
maneuvered as usual but not actually fired. This will allow patients to be blinded to their 
treatment. If at the end of the trial, laser depilation is shown to be effective, patients 
randomized to placebo will be offered laser therapy at the conclusion of the trial at no charge. 
 
 
Topical Anesthetic: 
Application of 23% lidocaine cream applied approximately 45 minutes prior to the laser 
depilation treatments. This will aid in the subsequent tolerance of the laser treatment.  
 
Laser Depilation: The two lasers that will be used in this study (810 nm or Nd:YAG) are both 
FDA approved for hair removal in all areas of the human body including the back. These lasers 
are being used for hair removal in the back region for which they have FDA approval; however 
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they do not have specific approval for pilonidal disease. In discussion with Chris Shilling, 
Director of the Drug and Device Development Services at the RINCH, we believe that an IDE is 
not necessary for this study as we are using an approved device for investigational purposes with 
non-significant risk. Laser use in this study poses minimal risk to the patient and these minimal 
risks are similar to the risks associated with hair removal in the back and other regions of the 
body for which devices are already FDA approved.       
 
Follow-Up: 
Initial follow up for the laser depilation group will be performed to assess for tolerance of the 
laser treatment. This will occur via use of a REDCap database system where patients can 
report their pain every 6 hours (with the exception of the overnight period from 8pm-8am) 
for the first 48 hours after their laser hair depilation treatment. Text message reminders will 
be sent to these patients for them to give us their pain scores. For those with smart phones, 
we can text them the link to their REDCap survey, and for those without smart phones or 
without consistent access to the interne, we can receive their pain scores via return text 
messages from them. Once tolerance is established, patients will return to surgical clinic 
every month for their laser or placebo visit. After the 5th clinic visit, they will receive a 
telephone call monthly to assess for any evidence of resolution or recurrence of disease up to 
1 year after the completion of the treatments. 
 
5. Statistical Considerations 
 
5.1. Primary and Secondary Endpoints 
Primary endpoints would be the tolerance of the laser depilation treatments based on a pain score 
consistently <4 and no occurrence of deep second degree burns. These endpoints will be assessed 
within the first week after each treatment. Secondary endpoints include clinical improvement of 
pilonidal inflammation and drainage. For Phase Two, the primary endpoint will be the rate of 
recurrent pilonidal disease at 1 year. 
 
5.2. Statistical Methods 
 
The means/medians and standard deviations/interquartile ranges of the prognostic variables will 
be evaluated in the total study sample and will be compared between groups (in the phase 2 
study) using t-tests or Mann Whitney U tests for continuous variables and chi-squared tests for 
categorical variables. For the primary outcome of recurrence within one year, we will calculate 
this proportion and its 95% confidence, based on the exact binomial distribution, in the laser hair 
depilation group (in the phase 1 study), and we will calculate this proportion and its 95% 
confidence in both treatment groups (in the phase 2 study) and compare this proportion between 
groups using a Fisher exact test. SAS version 9.3 (Cary, NC) and Stata version 12 (College 
Station, TX) will be used in the statistical analyses. 
 
5.3. Sample Size and Power 
We anticipate a group of 10 patients to measure laser depilation tolerance. If tolerance is good 
(>95% the phase 1 patients pain scores < 4 with no deep second degree burns), we will proceed 
to the phase 2 study. The sample size for phase 2 will be 164 patients. Since the predicted 
recurrence rate in the control group based on previous studies may be 20% and in the laser group 
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will be 5%, we would need 82 patients in each treatment group in order to detect this difference 
at a one-sided alpha of 0.025 using a Fisher exact test. 
 
6. Study Administration 
Phase One: Pilot Study 
 
6.1. Data Collection and Management 
Patient data such as age, gender, skin type, length of disease, past medical/surgical history, 
number/date of treatments, treatment parameters, patient pain scores after laser treatments and 
within the first 12 hours after treatment, and any subsequent episodes of folliculitis/drainage. 
This information will be kept by the study team and access restricted to the study team.  
 
6.2. Regulatory and Ethical Considerations 
 
6.2.1. Risk Assessment 
Patients will be evaluated for their skin type to ensure adequate treatment across the 
categories. 
 
Laser Depilation Group  
 
Potential risks may include:  
• No relief of symptoms  
• Recurrence of pilonidal abscess or wound complication  
• Photosensitivity or discomfort from laser treatments 
• Lastly, loss of confidentiality could be a risk. 
 
No Laser Depilation group 
• Loss of confidentiality could be a risk. 
 
6.2.2. Potential Benefits of Trial Participation 
 
 
Laser Depilation Group  
 
Potential benefits may include: 
• Faster relief of symptoms (ex: resolution of pain, erythema) 
• Avoiding surgery altogether 
o No risk of surgical complications  
• Possible decrease in folliculitis or recurrence  
 
No Laser Depilation Group  
• Possible decrease in folliculitis or recurrence due to better hair removal from multiple 
clinic visits 
 
6.2.3. Risk-Benefit Assessment/Risk Minimization 
 
 
Laser Depilation Group 
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Potential benefits include a decrease in the likelihood of recurrent pilonidal disease. The 
likely risk are pain or burns from laser treatments which will be minimized by applying 
topical anesthetics and using skin type specific lasers with graded increases in applied 
power.  
 
6.2.4. Data safety and monitoring 
Tolerance to the laser treatments will be monitored closely, especially in the first 48 
hours of the laser hair depilation treatments. Treatments will stop at any point in which 
the patient reports enough discomfort to terminate therapy. Areas treated will be observed 
for cutaneous changes including excessive erythema, discoloration, or tenderness. Data 
will be monitored by research team members daily. They will ensure that all data (clinical 
data and questionnaires) collected are correctly completed. Any suggestion of an adverse 
event identified by this person will be discussed with the principal investigator 
immediately.   
 
 
6.2.5. Adverse events (AE) and Serious adverse events (SAEs) 
Any adverse events such as an inability to tolerate the laser therapy or a recurrence will 
be tracked. Since recurrence is an expected adverse event it will not be reported; however 
it will be monitored and if we detect an increased rate of recurrence with laser therapy, 
this will be reported and the trial will be stopped. Mild to moderate pain (pain score 7 or 
lower) secondary to laser therapy is also consider an expected adverse event and will not 
be reported. SAEs due to laser treatment include severe pain (pain score 8 or higher) and 
deep second degree burns.  
 
 
It is also possible that AE might occur that are not directly related to the study.  As such, 
all AE will be classified as not related (clearly unrelated to study participation), possibly 
related (temporally related to study participation but could have been caused by other 
factors), or probably related (temporally related to study participation and cannot be 
reasonably explained by other factors) to study participation. The clinical study team will 
review all AE as they occur and determine the seriousness and relatedness of them.  
 
 
We do not expect any severe AE in either study group. The clinical study team will 
review any SAE as they occur. All SAE deemed probably related to the study (and all 
deaths) will be reported to the IRB within 72 hours of discovery.   
 
 
6.3. Recruitment Strategy 
Patients who present to Pediatric Surgery clinic will be approached to evaluate whether they 
would be interested in taking part in the study. In addition, patients admitted after initial surgical 
drainage of a pilonidal abscess will be approached to evaluate whether they would be interested 
in taking part in the study Risks and benefits would be explained, informed consent and assent 
will be obtained, and we would schedule the patient for their first treatment.  
 
6.4. Informed Consent/Assent 
 
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All informed consents and assents will be performed by a physician-member of the research 
team. 
 
If the child and legal guardian (for subjects < 18 years) are interested in participating in this 
study, a physician-member of the research team will guide the child and legal guardian through 
the informed consent/assent process. Written informed consent will be obtained from one legal 
guardian of subjects < 18 years of age and from the patient him or herself if he or she is ≥ 18 
years of age.  Written informed assent will be obtained from subjects ≥9 and < 18 years of age.   
 
 
Refusal to participate in the study will not affect the child’s clinical care. Participants and their 
legal guardian have the right to switch to the standard treatment and/or withdraw from the study 
at any time. Withdrawal from the study will not affect receipt of clinical care. 
 
6.5. Payment to Subjects/Families 
Laser depilation treatments will be provided at no cost to the patient. All clinic visits and 
medications related to the study will be provided at no cost to the patient.  
 
6.6. Confidentiality 
 
Privacy and security will be maintained by minimizing the amount of identifiable data as much 
as possible. Only study identifications (IDs) will be used to identify patients on all data forms 
and all datasets used for analysis. The file linking study IDs to patient names and medical record 
numbers (MRNs) will be password protected and will not be made available to non-study staff or 
used during data analysis. All study information will be compiled in REDCAP, to which only 
study staff will have access. 
 
Phase Two: Randomized control trial 
 
7.1. Data Collection and Management 
Patient data such as age, gender, skin type, length of disease, past medical/surgical history, 
number/date of treatments, treatment parameters, patient pain scores after laser treatments and 
within the first 12 hours after treatment, and any subsequent episodes of folliculitis/drainage. 
This information will be kept by the study team and access restricted to the study team.  
 
7.2. Regulatory and Ethical Considerations 
 
7.2.1. Risk Assessment 
Patients will be evaluated for their skin type to ensure adequate treatment across the 
categories. 
 
Laser Depilation Group  
 
Potential risks may include:  
• No relief of symptoms  
• Recurrence of pilonidal abscess or wound complication  
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• Photosensitivity or discomfort from laser treatments 
• Lastly, loss of confidentiality could be a risk. 
 
No Laser Depilation group 
• Loss of confidentiality could be a risk. 
 
 
7.2.2. Potential Benefits of Trial Participation 
 
 
Laser Depilation Group  
 
Potential benefits may include: 
• Faster relief of symptoms (ex: resolution of pain, erythema) 
• Avoiding surgery altogether 
• No risk of surgical complications  
• Possible decrease in folliculitis or recurrence  
 
No Laser Depilation Group  
• Possible decrease in folliculitis or recurrence due to better hair removal from multiple 
clinic visits 
 
7.2.3. Risk-Benefit Assessment/Risk Minimization 
 
 
Laser Depilation Group 
Potential benefits include a decrease in the likelihood of recurrent pilonidal disease. The 
likely risk are pain or burns from laser treatments which will be minimized by applying 
topical anesthetics and using skin type specific lasers with graded increases in applied 
power.  
 
7.2.4. Data safety and monitoring 
Tolerance to the laser treatments will be monitored closely, especially in the first 48 
hours of the laser hair depilation treatments. Treatments will stop at any point in which 
the patient reports enough discomfort to terminate therapy. Areas treated will be observed 
for cutaneous changes including excessive erythema, discoloration, or tenderness. Data 
will be monitored by research team members daily. They will ensure that all data (clinical 
data and questionnaires) collected are correctly completed. Any suggestion of an adverse 
event identified by this person will be discussed with the principal investigator 
immediately.   
 
 
7.2.5. Adverse events (AE) and Serious adverse events (SAEs) 
Any adverse events such as an inability to tolerate the laser therapy or a recurrence will 
be tracked. Since recurrence is an expected adverse event it will not be reported; however 
it will be monitored and if we detect an increased rate of recurrence with laser therapy, 
this will be reported and the trial will be stopped. Mild to moderate pain (pain score 7 or 
lower) secondary to laser therapy is also consider an expected adverse event and will not 
2/1/2016 
15 
 

be reported. SAEs due to laser treatment include severe pain (pain score 8 or higher) and 
deep second degree burns..  
 
 
It is also possible that AE might occur that are not directly related to the study.  As such, 
all AE will be classified as not related (clearly unrelated to study participation), possibly 
related (temporally related to study participation but could have been caused by other 
factors), or probably related (temporally related to study participation and cannot be 
reasonably explained by other factors) to study participation. The clinical study team will 
review all AE as they occur and determine the seriousness and relatedness of them.  
 
 
We do not expect any severe AE in either study group. The clinical study team will 
review any SAE as they occur. All SAE deemed probably related to the study (and all 
deaths) will be reported to the IRB within 72 hours of discovery.   
 
 
 
7.3. Recruitment Strategy 
Patients who present to Pediatric Surgery clinic will be approached to evaluate whether they 
would be interested in taking part in the study. In addition, patients admitted after initial surgical 
drainage of a pilonidal abscess will be approached to evaluate whether they would be interested 
in taking part in the study Risks and benefits would be explained, informed consent and assent 
will be obtained, and we would schedule the patient for their first treatment.  
 
7.4. Informed Consent/Assent 
 
All informed consents and assents will be performed by a physician-member of the research 
team. 
 
If the child and legal guardian (for subjects < 18 years) are interested in participating in this 
study, a physician-member of the research team will guide the child and legal guardian through 
the informed consent/assent process. Written informed consent will be obtained from one legal 
guardian of subjects < 18 years of age and from the patient him or herself if he or she is ≥ 18 
years of age.  Written informed assent will be obtained from subjects ≥9 and < 18 years of age.   
 
 
Refusal to participate in the study will not affect the child’s clinical care. Participants and their 
legal guardian have the right to switch to the standard treatment and/or withdraw from the study 
at any time. Withdrawal from the study will not affect receipt of clinical care. 
 
7.5. Payment to Subjects/Families 
Laser depilation treatments will be provided at no cost to the patient. All clinic visits and 
medications related to the study will be provided at no cost to the patient.  
 
7.6. Confidentiality 
 
Privacy and security will be maintained by minimizing the amount of identifiable data as much 
as possible. Only study identifications (IDs) will be used to identify patients on all data forms 
2/1/2016 
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and all datasets used for analysis. The file linking study IDs to patient names and medical record 
numbers (MRNs) will be password protected and will not be made available to non-study staff or 
used during data analysis. All study information will be compiled in REDCAP, to which only 
study staff will have access. 
 
8. References 
 
 
1. Bendewald FP, Cima RR. Pilonidal Disease. Clinics in Colon and Rectal Surgery. 
2007;20(2):86-95. doi:10.1055/s-2007-977486. 
 
2. Ertan T, Koc M, Gocmen E, Aslar AK, Keskek M, Kilic M. Does technique alters quality 
of life after pilonidal sinus surgery? Am J Surg. 2005;190:388–92. 
 
3. Matter I, Kunin J, Schein M, Eldar S. Total excision versus non-resectional methods in 
the treatment of acute and chronic pilonidal disease. Br J Surg. 1995;82:752–753. 
 
4. Lukish JR, Kindelan T, Marmon LM, Pennington M, Norwood C. Laser epilation is  
a safe and effective therapy for teenagers with pilonidal disease. J Pediatr 
Surg. 2009 Jan;44(1):282-5. doi: 10.1016/j.jpedsurg.2008.10.057.  
 
5. McCallum IJD, King PM, Bruce J. Healing by primary closure versus open healing after 
surgery for pilonidal sinus: systematic review and meta-analysis. BMJ 2008; 336:868-71. 
 
6.   Social Security Administration Disability Insurance Website: 
https://www.ssa.gov/disability/professionals/bluebook/108.00-Skin-Childhood.htm#108_06. 
Accessed December 8, 2015. 
 
7.  Jensen S L, Harling H. Prognosis after simple incision and drainage for a first-episode 
acute pilonidal abscess.  Br J Surg. 1988;  75 60-61. 
 
8.  Lee SL, Tejirian T, Abbas MA. Current management of adolescent pilonidal 
disease. J Pediatr Surg. 2008 Jun;43(6):1124-7. doi:10.1016/j.jpedsurg.2008.02.042.  
 
9. Maurice BA, Greenwood RK. A conservative treatment of pilonidal sinus. Br J 
Surg. 1964 Jul;51:510-2. PubMed PMID: 14199061. 
 
10. Schneider IH, Thaler K, Köckerling F. Treatment of pilonidal sinuses by phenol 
injections. Int J Colorectal Dis. 1994;9(4):200-2. PubMed PMID: 7876724. 
 
11. Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with 
crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 
Nov;47(11):1934-8. PubMed PMID: 15622588. 
 
12. Hegge HG, Vos GA, Patka P, Hoitsma HF. Treatment of complicated or infected 
pilonidal sinus disease by local application of phenol. Surgery. 1987 
Jul;102(1):52-4. PubMed PMID: 3589976. 
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13. Søndenaa K, Andersen E, Nesvik I, Søreide JA. Patient characteristics and 
symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 
1995;10(1):39-42. PubMed PMID: 7745322. 
 
14. Lund JN, Leveson SH. Fibrin glue in the treatment of pilonidal sinus: results  
of a pilot study. Dis Colon Rectum. 2005 May;48(5):1094-6. PubMed PMID: 15868239. 
 
15. Odili J, Gault D. Laser depilation of the natal cleft--an aid to healing the 
pilonidal sinus. Ann R Coll Surg Engl. 2002 Jan;84(1):29-32. PubMed PMID: 
11890622. 
 
16. Schulze SM, Patel N, Hertzog D, Fares LG 2nd. Treatment of pilonidal disease 
with laser epilation. Am Surg. 2006 Jun;72(6):534-7. PubMed PMID: 16808209. 
 
17. Landa N, Aller O, Landa-Gundin N, Torrontegui J, Azpiazu JL. Successful 
treatment of recurrent pilonidal sinus with laser epilation. Dermatol Surg. 2005  
Jun;31(6):726-8. PubMed PMID: 15996432. 
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9. Appendix: 
 
Pain Scales used:  
 
http://anchor.columbuschildrens.net/pain-management-assessment-directory 
 
Visual Analog Scale (VAS) (8 years of Age and Older) 
 
On this chart the “0” means no pain, each number means a little more pain, and “10” 
means the most pain possible. 
 
 
 
 
   
 
No pain                                                                                                                      Terrible pain                                             
 
QIS-6   Pain Management Scale   4/04  
 
 
All of the different scales are described and examples are available at the above website (FLASS, 
FACES and VAS).  
 
 
 
Fitzpatrick Skin Types: 
 
 
 
 
 
 
 
 
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Physician Informed Consent Script: 
 
Good morning/afternoon. My name is Dr. _______. I work with Dr. Katherine Deans and Dr. 
Peter Minneci at the Department of Surgery at Nationwide Children’s Hospital. I know that your 
child has been seen here at Nationwide Children’s Hospital for his/her pilonidal disease. We are 
doing a research study that is examining a possible treatment which might be successful in 
treating this problem. I’d like to tell you about our research study on the use of laser hair removal 
in pilonidal disease. May I tell you more about this? 
 
{If Yes} 
 
As surgeons, we all have different beliefs on how to best treat pilonidal disease in adolescents 
and young adults. Some surgeons believe that surgery to remove the infected tissue is the best 
way to treat this disease. There is evidence that the cause of this problem may be related to 
infected hair follicles in this body area which become long term infections over time. So we are 
conducting a study to investigate whether using laser hair removal treatments is a successful way 
to treat the problem as it develops and also help prevent this problem from returning. 
 
In this pilot study, we are seeing how well patients tolerate laser hair removal treatments. Let me 
explain the risks and benefits. 
 
 Risks of laser hair removal for this problem include the following: 
• No relief of symptoms  
• Return of pilonidal disease  
• Discomfort from laser treatments 
Benefits of laser hair removal for this problem include the following: 
• Possible faster relief of symptoms (ex: resolution of pain, redness) 
• Avoiding surgery altogether 
• No risk of surgical complications  
• Possible decreased risk of return of the pilonidal disease  
 
Please remember that your participation is voluntary and you can decide not to be in the study at 
any point. I will now explain what you can expect as a patient. When coming in for your 
treatment appointment, we will bring you to the exam room. There, we will shave the pilonidal 
area and apply a lidocaine anesthetic (numbing) cream on your skin which will remain there for 
about 45 minutes. After this, we will then use the laser on the area. This process should only take 
a few moments. Please tell us if you feel any pain during or immediately after the treatment. 
After your visit, please let us know (via text or email) your pain score from 1-10 (10 being the 
highest level of pain) at 6, 12, 18, and 24 hours after your treatment visit.  
 
What questions may I answer for you? 
 
Would you be willing to take part in this study? 
 
{No - Thank you for your time.} 
 
{Yes - Excellent. Thank you for your participation.}  
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20 
 

 
Our number is (614) 722-0742; it will be on the bottom of the emails that you receive from us. 
Please do not hesitate to call with any questions or concerns. 
I will meet with you when you come here to review our consent form on paper and I will give 
you a copy of the form. 
 
 
 
 
Follow up Data Collection Forms:  
 
 
Name: 
Pain Score Report: 6 Hours Post-
Treatment (1-10) 
Other concerns: 
Date: 
 
 
 
 
Name: 
Pain Score Report: 12 Hours Post-
Treatment (1-10) 
Other concerns: 
Date: 
 
 
 
 
Name: 
Pain Score Report: 18 Hours Post-
Treatment (1-10) 
Other concerns: 
Date: 
 
 
 
 
Name: 
Pain Score Report: 24 Hours Post-
Treatment (1-10) 
Other concerns: 
Date: 
 
 
 
 
Name: 
Pain Score 
Report  
___ Month(s) 
Post-
Treatment  
Number of 
laser 
treatments 
to date 
Erythema 
Drainage 
Other concerns 
Date: 
 
 
 
 
 
 
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21 
 

 Initial Data Collection Sheet: 
Name 
MRN 
Ge
nde
r 
Age 
Heig
ht 
(cm)  
Weig
ht 
(Kg) 
Race 
 
 
 
 
Fitzpatrick skin 
classification 
(I-VI) 
Date of 
initial 
diagnosis  
Date of initial 
Incision and 
Drainage or 
Antibiotic 
Treatment 
Date of 
previous 
surgical 
excision 
procedure 
Randomization 
Group (laser 
hair depilation 
vs. placebo) 
Laser type 
used 
(Nd:YAG or 
810 nm) 
Number of 
laser 
treatments  
Time 
since 
last 
laser 
treatme
nt 
(Weeks) 
Recurrent 
folliculitis 
present at any 
follow-up? 
(Y/N) 
Adverse events 
(photosensitivity
, irritation from 
depilation 
methods, etc.) 
Pain 
score 
Immedia
tely 
after 
treatme
nt (1-10
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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