Pilonidal Disease
Conditions
Brief summary
It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.
Detailed description
Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10. Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit. Twenty patients will be recruited and each patient will act as their own control.
Interventions
Topical lidocaine cream prior to laser follicle ablation
DRUGSham cream
Placebo cream without lidocaine will be placed and removed before laser.
Sponsors
David Mooney
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Cream will be applied by a clinician not involved in the laser procedure and will be removed prior to the procedure. Laser technicians will assess patient pain and will be blinded, as will the patient, to the study arm.
Intervention model description
Placebo versus agent crossover per patient
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -
Exclusion criteria
Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain related to laser follicle ablation | 5 minutes | Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure. |
Countries
United States
Outcome results
None listed