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Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial
- Source :
- Trials, Vol 19, Iss 1, Pp 1-8 (2018), Trials
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
Abstract
- Background Laser 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. Methods We 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. Discussion This 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 registration ClinicalTrials.gov, NCT03276065. Registered on 8 September 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2987-7) contains supplementary material, which is available to authorized users.
- Subjects :
- Pilonidal disease
Pediatrics
medicine.medical_specialty
Adolescent
Pilonidal abscess
Medicine (miscellaneous)
Folliculitis
Disease
Hair Removal
law.invention
Study Protocol
Young Adult
030207 dermatology & venereal diseases
03 medical and health sciences
Pilonidal Sinus
0302 clinical medicine
Laser hair depilation
Randomized controlled trial
Quality of life
Recurrence
law
Health care
medicine
Humans
Pharmacology (medical)
Young adult
10. No inequality
Randomized Controlled Trials as Topic
lcsh:R5-920
business.industry
medicine.disease
3. Good health
Sample Size
030220 oncology & carcinogenesis
Laser Therapy
lcsh:Medicine (General)
business
Surgical incision
Follow-Up Studies
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 19
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....bc9aa58fd72b7e8c67589be44d4a31b1