SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study. (NCT07260643) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.
40 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Clinical diagnosis of chronic pilonidal sinus disease.
* Undergoing surgery using the SiLaC (Sinus Laser-Assisted Closure) technique.
* Signed informed consent for the use of anonymized clinical data for research purposes.
Exclusion Criteria:
* Patients with inflammatory bowel disease or complex anorectal fistulas.
* Severe immunosuppression (active chemotherapy, high-intensity immunosuppressive therapy, uncontrolled HIV).
* Prior pelvic radiotherapy.
* Missing essential clinical data required for outcome assessment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.