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Randomized controlled trial of laser hair depilation in adolescents with pilonidal disease
Investigator (PI): Minneci, Peter
Performing Organization (PO): (Current): Nationwide Children's Hospital, Research Institute / (614) 722-2000
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/ CER-2017C1-6441
Funding: Total Award Amount: $1,083,377
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Pilonidal disease is a common and painful skin infection that occurs in the crease of the buttocks near the tailbone (gluteal cleft). One out of a hundred people between the ages of 15 and 30 will get it. It is caused by hair getting trapped under the skin surface which leads to infections. Many patients may have more than one episode of infection and this can lead to ongoing drainage with open areas in the skin. These infections are usually treated with antibiotics and oftentimes require surgery to either drain the infection (incision and drainage) or to remove the area of skin and fat that keeps getting infected (surgical resection). Pilonidal disease can lead to prolonged dependence on caregivers, long-term disability, reduced quality of life, and social withdrawal. Patients may need multiple surgeries, frequent hospital admissions, and have to live with open, foul-smelling wounds for months. They oftentimes have to miss school or work, cannot attend social events, and cannot play sports. In some cases, they need to repeat years of high school and college due to extended periods of medical leave. Patients also report feeling embarrassed and ashamed of their disease and having to depend on their caregivers to help them with their wounds and hair removal. Treatment of pilonidal disease involves keeping the area clean and free of hair by shaving it (mechanical hair removal) or using hair-removal creams (chemical hair removal) and treating recurrent infections with antibiotics and intermittent incision and drainage procedures. The American Society of Colon and Rectal Surgeons recommends that the skin in the buttocks crease be shaved or have chemical hair removal every 2-3 weeks until the age of 30 to prevent recurrent disease. However, recurrent pilonidal disease is common. Recurrence rates after initial incision and drainage or surgical resection have been reported to be as high as 30-40%. In addition, wound complications after resection have been reported to be as high as 30%. Since the morbidity associated with disease recurrence is high, many authors have stressed the need to prevent recurrence and recommend chronic hair removal to the gluteal cleft through the age of 30. However, patient compliance with these recommendations for chronic hair removal is low. Therefore, laser hair depilation of the gluteal cleft, which leads to nearly permanent hair removal, has been studied as a treatment to reduce the recurrence of pilonidal disease. Several studies in adults and adolescents have demonstrated the efficacy of laser hair depilation to reduce pilonidal disease recurrence compared to standard care, but most of these studies were small or not well controlled. Therefore, additional well-controlled prospective studies are needed to establish the effectiveness of laser hair removal prior to recommending it to all patients. The goal of this project is to determine if laser hair removal can decrease pilonidal disease recurrence. We propose to perform a randomized controlled trial comparing laser hair removal with mechanical/chemical hair removal (laser group) to mechanical/chemical hair removal alone (control group). Our patient stakeholders strongly believe that disease recurrence is the most important outcome to target in a study of laser hair removal because they live in fear of the disruption and disability that recurrent disease incurs in their lives. If laser hair removal reduces pilonidal disease recurrence, then patients will experience fewer episodes of painful recurrent disease, fewer disruptions to their daily schedule, less disability, fewer missed days of school or work, and a better quality of life. Furthermore, lower recurrence rates will lead to fewer surgical procedures overall. Given that surgical resection is associated with a high complication rate and months of disability, a smaller number of patients will be exposed to this greater level of morbidity. We will compare the rate of recurrence of pilonidal disease at one year between the laser hair removal group and the control. We believe that laser hair removal will lead to lower rates of disease recurrence at one-year follow-up compared to control. We also believe that laser hair removal will lead to less morbidity, including less disability, higher quality of life, higher health care satisfaction, fewer procedures, fewer surgical resections, and fewer postoperative complications in patients who do undergo resection. Positive results from this study may transform the treatment paradigm of pilonidal disease from one in which patients, families, and physicians anticipate recurrences to one in which a less invasive office-based therapy may do away with recurrent disease entirely. This study will measure differences in important outcomes to patients and their families. These results will inform patients, families, and physicians about the risks, benefits, and outcomes associated with each treatment option. Results from this study can be widely disseminated and applied to the treatment of pilonidal disease in adolescent and adult patients. The proposed project was designed with the help of a multidisciplinary stakeholder group that includes patients, caregivers, community-based pediatricians, emergency medicine physicians, adult and pediatric surgeons, and nurses. In addition, we have included patient educators, payers, and representatives of the American Academy of Pediatrics Section on Surgery, the American Pediatric Surgical Association, the Surgical Infection Society, and the Pilonidal Support Alliance. Our stakeholders helped us to design this study and choose the outcomes that are most meaningful to patients and their families. They are committed to be a part of our research team until the study is completed and will provide their perspectives on issues related to recruitment, retention, study progress, and developing plans for dissemination and implementation of the results.
MeSH Terms:
  • Adolescent
  • Caregivers
  • Hair Removal
  • Humans
  • Laser Therapy /*methods
  • Outcome Assessment (Health Care)
  • Patient Admission
  • Patient Participation
  • Pilonidal Sinus /*therapy
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Recurrence
  • Skin Diseases /*therapy
  • Young Adult
Country: United States
State: Ohio
Zip Code: 43205
UI: 20184256
CTgovId: NCT03276065
Project Status: Ongoing