About this trial
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 10-21 years
Diagnosis of pilonidal disease
Fitzpatrick skin type IV, V, or VI
Disqualifiers
History of photosensitivity
Actively inflamed pilonidal sinus (will be offered enrollment upon resolution).
Trial design
Parallel
Treatments tested in this trial
Laser hair depilation
Procedure/SurgeryLaser hair depilation treatment with Nd:YAG laser every 4-6 weeks to obtain a total of 5 treatments. Similar to the control group, they will also receive the "best recommended standard care" including teaching on hair removal techniques and asked to perform either chemical or mechanical depilation as needed between treatments.
Treatment groups
Trial outcomes
Primary outcomes
Disease Recurrence
Disease recurrence is defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic therapy, additional surgical incision and drainage, or excision. development of an abscess, folliculitis, or draining sinus which requires treatment (antibiotic therapy, surgical incision and drainage, or excision).
Secondary outcomes
Disability days
Disability days will be defined as all days in which the patient was not able to participate in all normal activities secondary to pilonidal disease within 1 year.
health-related quality of life (HRQOL) and healthcare satisfaction
The PedsQLTM Quality of Life Inventory: Child and Parent Report questionnaire will be used to assess HRQOL. The PedsQLTM Healthcare Satisfaction Generic Module: Parent Report will be used to assess healthcare satisfaction.
Rates of pilonidal disease-related complications
Complications include physician, Emergency Department (ED), and urgent care visits, hospital admissions, and additional surgical procedures.
Rates of pilonidal disease-related procedures
Procedures will include incision and drainage procedures and surgical excisions, and their respective post-operative complications
Sponsors and contacts
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Nemours Children's Clinic
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator