Pilonidal Disease
Conditions
Brief summary
This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.
Detailed description
This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.
Interventions
PROCEDURELaser hair removal
Those who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks.
Sponsors
Syneron Candela
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention: * Experience two or more episodes of infection or abscess in the past 12 months * Have pain or drainage for a total of more than 1 month in the past 12 months * Missed a total of more than 1 week of school or work in the past 12 months * English-speaking
Exclusion criteria
* Patients who have co-morbidities that prevent them from becoming a surgical candidate * Previous history of laser hair removal in the gluteal cleft (prior to initial enrollment) * Previous excision of pilonidal sinus (prior to initial enrollment) * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of disease-free remission | up to 2 years | Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months. |
| Disease recurrence rate among subjects who subsequently require surgical intervention. | up to 2 years | Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain via Promis 3A Pain Short Form | up to 18 months | This study will investigate qualitative outcomes including pain. Pain will be assessed via the Promis 3A Pain Short Form at 6, 9, and 18 months. This is a one question survey that has participants rate the intensity of their pain over the last 7 days, on average. The scale is from 0-10 where 0 is no pain and 10 is the worst pain imaginable. |
| Characterization of the degree of intervention required to obtain positive results. | up to 2 years | Incision and drainage vs. need for larger excision, requirement for oral antibiotics, and the number of emergency room visits, or hospital admissions related to pilonidal disease. |
| Cost-benefit analysis of laser hair-treated patients versus matched historical control. | up to 2 years | Evaluate total cost to the health care system relative to period of disease-free remission. |
| Number of Days Participants Experience Drainage | up to 18 months | This study will investigate qualitative outcomes including assessment of drainage. This will be reported as the number of days participants experienced drainage since last follow up, assessed at 6, 9, and 18 month follow up. |
| Number of missed school or work days | Up to 18 months | This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months. |
Countries
United States
Outcome results
None listed