Clinical Trial

SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.

Study acronym: SiLaC-LaPaz
Not Yet Recruiting
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Record status
This record was last updated December 9, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the sacrococcygeal region that frequently affects young adults, often causing pain, drainage, and recurrent infection. Traditional surgical approaches such as wide excision or flap techniques may result in prolonged healing times, relevant postoperative pain, and recurrence rates up to 20-30%. The SiLaC (Sinus Laser-Assisted Closure) technique is a minimally invasive procedure that uses a 1470-nm diode laser fiber to ablate the sinus epithelium and induce concentric contraction of the tract. International studies have reported promising results with faster recovery, minimal wound care, and low morbidity. This prospective single-center cohort study aims to evaluate the clinical outcomes and perceived recovery time of adult patients treated with the SiLaC® technique at Hospital Universitario La Paz (Madrid, Spain). The main outcome is the total recovery time perceived by patients after surgery. Secondary outcomes include postoperative complications, recurrence rate, pain intensity, need for wound care, and patient satisfaction. Data will be collected from medical records and structured follow-up interviews.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-21.
Trial Details
NCT Number NCT07260643
Lead Sponsor Hospital Universitario La Paz
Conditions Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess, Pilonidal Sinus, Pilonidal Cysts, Pilonidal Sinus Treatment
Enrollment 40 participants
Start Date 2025-12-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-09