Laser Hair Removal for Treatment of Pilonidal Disease

University of Wisconsin, Madison22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pilonidal Disease

Interventions

Laser hair removalPROCEDURE

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Incidence of disease-free remission

Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months.

Time frame: up to 2 years

Disease recurrence rate among subjects who subsequently require surgical intervention.

Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention.

Time frame: up to 2 years

Secondary Outcomes

Characterization of the degree of intervention required to obtain positive results.

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.

Time frame: up to 2 years

Number of missed school or work days

This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months.

Time frame: Up to 18 months

Assessment of Pain via Promis 3A Pain Short Form

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.

Time frame: up to 18 months

Number of Days Participants Experience Drainage

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.

Data from ClinicalTrials.gov

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