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NCT07260643

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

Sponsor: Hospital Universitario La Paz

View on ClinicalTrials.gov

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.

Official title: Valuation of Laser-Assisted (SiLaC®) Technique for the Management of Pilonidal Sinus in Adults: A Prospective Single-Center Cohort at Hospital Universitario La Paz.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-12-01

Completion Date

2026-08-31

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

PROCEDURE

SilaC

The SiLaC procedure is a minimally invasive laser technique for the management of chronic pilonidal sinus. It uses a 1470-nm diode laser radial fiber to ablate the sinus tract epithelium after curettage, inducing concentric contraction of the cavity. In this study, patients are observed as part of routine clinical care; the procedure is not assigned or modified by the study protocol.