Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Pilonidal disease is a painful skin infection that affects 1 out of 100 people between the ages of 15 and 30. Hair can become trapped under the skin in the crease of the buttocks, near the bottom of the spine, causing infection. The area can become swollen and develop into a cyst that contains pus.
Patients with pilonidal disease usually get antibiotics to treat infections. Many patients also need surgery to either drain pus or remove the infected area. Patients report feeling embarrassed about having pilonidal disease. They also report feeling ashamed about depending on caregivers such as family or friends to help with their treatment.
Some patients have only one episode of pilonidal disease, but other patients experience repeated infections. These infections can disrupt patients’ lives and require long periods of medical leave. Patients may have to live with open, bad-smelling wounds. They may miss school, work, or social events and cannot play sports. Patients who miss many days of school may have to repeat years of high school or college. Patients may also need multiple surgeries and frequent hospital stays. Almost one in three patients has complications with the wound after surgery.
Doctors recommend preventing repeat infections by shaving or regularly using hair removal creams to keep the affected area free of hair. This study is comparing two hair removal treatments for people with pilonidal disease: laser hair removal along with shaving or hair removal creams, and shaving or hair removal creams alone. The research team wants to compare how many repeat infections patients in each group have.
Who can this research help?
Patients with pilonidal disease and their doctors can use findings from this study when considering how best to reduce repeat infections.
What is the research team doing?
The research team is enrolling 272 patients ages 12 to 20 who have pilonidal disease. The team is assigning patients, by chance, to one of two groups. Patients in the first group receive laser hair removal to the affected area every four to six weeks, for a total of five treatments. The type of laser treatment they get depends on their skin type and how their skin reacts to the laser. They also get a cooling pad and numbing cream for pain from the laser treatment. Patients and families learn hair removal methods to use between treatments to keep the area free of hair.
Patients and families in the second group do not get laser therapy, but they get training on how to remove hair by shaving or cream. They also get supplies for six months of hair removal. The research team is following both groups for one year to compare the number of infections that need treatment. Patients receive monthly calls from the team asking about new infections.
A group of patients, caregivers, doctors, and nurses are helping design and conduct the study. The research team also includes patient educators and advocates, members of professional medical organizations, and health insurers.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | People ages 12–20 with pilonidal disease |
| Interventions/ Comparators |
|
| Outcomes |
Primary: recurrence of pilonidal disease Secondary: days patient does not take part in normal activities because of pilonidal disease, quality of life related to health |
 |
1-year follow-up for primary outcome |
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Children -- 18 and under