Abstract
BackgroundLaser hair depilation is a promising therapy in the management of pilonidal disease. However, the large controlled trials needed to demonstrate the effectiveness of this practice have not been performed.MethodsWe designed a single-center randomized controlled trial that will enroll 272 patients with pilonidal disease. Patients will be randomized to receive laser hair depilation of the sacrococcygeal region or the best recommended standard of care. The primary outcome is the rate of recurrent pilonidal disease at 1 year, defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic treatment, additional surgical incision and drainage, or excision within 1 year of enrollment. Secondary outcomes include each of the following at 1 year: disability days of the patient, disability days of the caregiver, health-related quality of life, healthcare satisfaction, disease-related attitudes and perceived stigma, pilonidal disease-related complications, pilonidal disease-related procedures, surgical excision, postoperative complications, and compliance with recommended treatment.DiscussionThis study will determine the effectiveness of laser hair depilation to reduce pilonidal disease recurrence in adolescents and young adults as compared to the best recommended standard of care.Trial registrationClinicalTrials.gov, NCT03276065. Registered on 8 September 2017.
Highlights
Laser hair depilation is a promising therapy in the management of pilonidal disease
Laser hair depilation has been studied as a strategy to decrease pilonidal disease recurrence rates
Stakeholder team As this study was designed to assess outcomes related to pilonidal disease that are important to patients and their families, we designed this trial with significant input from a multi-disciplinary stakeholder group that includes patients, caregivers, community-based pediatricians, emergency medicine physicians, adult and pediatric surgeons, and nurses
Summary
Laser hair depilation is a promising therapy in the management of pilonidal disease. the large controlled trials needed to demonstrate the effectiveness of this practice have not been performed. Guidelines for the medical management of pilonidal disease support meticulous hygiene to the sacrococcygeal area and routine hair removal by mechanical or chemical depilation [5]. Compliance with these recommendations is low, and patients frequently suffer considerable morbidity related to disease recurrence [6]. Several studies have demonstrated the efficacy of laser hair depilation to reduce pilonidal disease recurrence compared to standard of care in both adults and children [7,8,9,10,11,12,13,14,15,16,17,18]. These studies conclude that laser hair depilation is a useful adjunct in preventing recurrence; most of these studies were small, retrospective, or not sufficiently controlled, and many of the authors have called for additional well-controlled prospective randomized controlled trials (RCTs) in a broader population [11, 15, 19, 20]
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