Radiofrequency Treatment Using the Fistura Procedure for Infected Pilonidal Sinus Safety, Effectiveness, and Patient Satisfaction Evaluated Over 6 Months

What this Trial Is About

Infected pilonidal sinus is a common condition that occurs more frequently in men, usually between the ages of 15 and 30. This trial evaluates a new radiofrequency treatment using the Fistura procedure for infected pilonidal sinus to measure its safety, effectiveness, and patient satisfaction. The study aims to address the limitations of traditional open wound surgery and newer laser techniques by using radiofrequency thermocoagulation, which has been used safely in treating anal fistulas. Participants will receive the radiofrequency treatment with fibers adapted for the size of the pilonidal sinus cavity. This method is believed to better destroy granulation tissue and assist healing. The study will monitor safety within 15 days after treatment and evaluate treatment efficiency and patient satisfaction at 1 month and 6 months post-treatment. Medical leave length will also be recorded. Participants will be assessed before and after treatment, including safety checks shortly after the procedure and follow-up visits to measure pain, healing, and satisfaction. The primary outcome focuses on safety within 15 days after treatment. Secondary outcomes include treatment efficacy at 6 months, pain levels, duration of medical leave, and satisfaction surveys. The total study period includes initial treatment and monitoring over 6 months to understand the treatments impact.

Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months