Effectiveness of Laser Hair Removal in Pilonidal Disease

Nationwide Children's Hospital302 enrolled

Overview

Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after initial incision and drainage and after resection have been reported to be 16% and 11% respectively. Furthermore, wound issues after resection with primary closure have been reported to be as high as 30%. 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. We are performing a randomized control trial of laser hair depilation plus chemical/mechanical depilation to examine outcomes related to recurrence of pilonidal disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

302

Conditions

Pilonidal Disease

Interventions

Fitzpatrick skin type classification will be assessed during the initial visit. The Fitzpatrick skin type classification is based on the level of pigmentation of the skin and its response to ultraviolet light (See Appendix). It will be used to select the best laser to perform hair removal for each patient. The laser treatment group will consist of an 810 nm (for Fitzpatrick skin types I-IV) or Nd:YAG (for Fitzpatrick skin types V-VI) 28 joule application at auto pulse duration for 400 ms. A cooling platform and application of 7% lidocaine/ 7% tetracaine cream, applied 45 minutes prior to treatment, will minimize any discomfort associated with the heat of the laser treatments.

Standard of care hair depilationOTHER

Patients and families in the standard of care group will be taught hair removal techniques and asked to perform either chemical or mechanical depilation as needed to keep the area hair-free. Patients will be given supplies for six months of hair removal.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All Fitzpatrick skin types * 11-21 years of age * Diagnosis of pilonidal disease Exclusion Criteria: * History of photosensitivity * Actively inflamed pilonidal sinus. These patients are invited to participate upon resolution of their inflamed sinus.

Outcomes

Primary Outcomes

Recurrence of pilonidal disease

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.

Time frame: 12 months

Secondary Outcomes

Disability Days

Defined as days that patient does participate in all normal activities due to their pilonidal disease

Time frame: 12 months

Health related quality of life

Measured using PedsQL scales

Time frame: 1 year