Laser Hair Removal for Treatment of Pilonidal Disease

University of Wisconsin (UW)

Status: Completed

Conditions: Pilonidal Disease

Treatments: Procedure: Laser hair removal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03949140

2018-1031

A539790 (Other Identifier)

SMPH/SURGERY/PEDIATRIC SURGERY (Other Identifier)

Protocol Version 6 (Other Identifier)

Details and patient eligibility

About

This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 13 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Laser hair removal treatment

Experimental group

Description:

Patients who choose to enroll will plan to undergo a total of up to 8 laser hair removal sessions every 4-6 weeks. If patients develop abscess or infection during this time, they will undergo I\&D and/or antibiotics, consistent with standard therapy for infection or abscess. If patients have 2 or more infections in 1 year, pain or drainage for more than 1 month, or miss more than 1 week of school or work due to ineffective treatment of pilonidal disease, these patients will undergo surgical excision and subsequent follow-up at surgeon's discretion. Patients will follow up at 2-4-week intervals for 3 months, then at 6, 9, and 18 months after conclusion of the laser therapy sessions. At all follow-up sessions, patients will be given the DQLI, CDQLI, and Promis 3A Pain survey. Unscheduled visits such as unplanned clinic visits, emergency department encounters, and hospitalizations, will be included in data collected for analysis of primary and secondary outcomes.

Treatment:

Procedure: Laser hair removal