About this trial
Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques.
The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost.
Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 64 years
Diagnosis of primary pilonidal sinus disease
Maximum of three sinus openings (pits)
History of no more than two previous abscess episodes
Disqualifiers
Recurrent or previously operated pilonidal sinus disease
More than three sinus openings
More than two previous abscess episodes
Acute abscess requiring emergency drainage at presentation
Trial design
Parallel
Treatments tested in this trial
SiLac (Laser Ablation)
Procedure/SurgeryLaser ablation of the pilonidal sinus tract performed according to the study protocol.
Phenol Application
Procedure/SurgeryChemical ablation with phenol performed according to the study protocol.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence Rate
Recurrence of pilonidal sinus disease defined as the presence of a new sinus opening, discharge, abscess formation, or need for additional surgical intervention during follow-up.
Secondary outcomes
Postoperative Pain (VAS Score)
Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Postoperative Analgesic Consumption
Use of analgesic medication after treatment, measured as the proportion of patients requiring analgesics and/or the total number of analgesic doses used during the early postoperative period.
Wound Healing Time
Time required for complete epithelialization of the treated area without discharge.
Wound-Related Complications
Occurrence of wound-related complications, including infection, abscess formation, cellulitis, seroma/hematoma, prolonged discharge (\>30 days), or need for additional medical or surgical intervention. Early (≤30 days) and late (\>30 days to 6 months) complications will be recorded separately.
Sponsors and contacts
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