Pilonidal Sinus DisorderSiLaC-LaPazNCT07260643
SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.
An observational study of Pilonidal Sinus Disorder and Pilonidal Cyst Without Abscess, run by Hospital Universitario La Paz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess, Pilonidal Sinus
- What is being tested?
- SilaC
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with chronic pilonidal sinus disease who undergo laser-assisted closure (SiLaC®) at the Department of General and Digestive Surgery, Coloproctology Section, Hospital Universitario La Paz (Madrid, Spain). Participants will be included consecutively between August 2024 and January 2026, with a minimum follow-up of 6 months after surgery.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the detailed description
Pilonidal sinus disease (PSD) represents a chronic, recurrent inflammatory disorder of the natal cleft that primarily affects young males. It is associated with risk factors such as obesity, prolonged sitting, and deep gluteal folds. Although not life-threatening, PSD significantly affects quality of life and healthcare resources due to recurrences and delayed wound healing.
Conventional surgical approaches, including excision with secondary healing or flap reconstruction (Limberg, Karydakis, Bascom), often require prolonged recovery and intensive postoperative care. Minimally invasive alternatives have been developed to improve patient recovery and reduce morbidity. Among them, the SiLaC® (Sinus Laser-Assisted Closure) technique employs a radial 1470-nm diode laser fiber to achieve epithelial destruction and tract contraction after curettage. Early evidence suggests favorable outcomes, but robust prospective data remain scarce, especially in Spain.
This study is an ambispective, descriptive, single-center cohort conducted at Hospital Universitario La Paz, Madrid. It includes all adult patients (≥18 years) who undergo SiLaC® surgery for chronic pilonidal sinus between August 2024 and January 2026. Data will be collected retrospectively from electronic health records and prospectively during follow-up visits and structured interviews.
The primary outcome is the total recovery time perceived by the patient (days from surgery to full return to normal activities).
Secondary outcomes include postoperative complications (minor or major), pain intensity (EVA 0-10), wound infection, recurrence within 6 months, patient satisfaction (0-10 scale), and number of wound care visits.
Data will be anonymized and analyzed descriptively using R software (version 4.3.1). Normality will be assessed with the Kolmogorov-Smirnov test; comparisons will use Student's t-test, Mann-Whitney, ANOVA, or Chi-square as appropriate. A significance level of p < 0.05 will be applied.
The study poses no additional risk, as SiLaC® is part of routine surgical practice. Ethical approval will be obtained from the Institutional Ethics Committee (CEIm of Hospital Universitario La Paz / IdiPAZ). Patient confidentiality will be guaranteed under EU Regulation 2016/679 and Spanish Law 3/2018.
- Conditions
- Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess, Pilonidal Sinus, Pilonidal Cysts, Pilonidal Sinus Treatment
- Being tested
- SilaC
- Keywords
- Pilondal sinus, Pilonidal Cyst, SilaC, laser-assisted closure, minimal invasive surgery, coloproctology, postoperative recovery
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilaCProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SilaC | Single cohort including all consecutive adult patients operated on using the SiLaC technique between August 2024 and January 2026. Data collected retrospectively and prospectively from clinical records and follow-up interviews Receives: Procedure: SilaC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perceived recovery time
Number of days from surgery to full return to normal activities, as reported by the patient during follow-up interviews
Measured: 90 days
Secondary outcomes (4)
Postoperative complications
Any adverse event (infection, seroma, hematoma, abscess, persistent pain ≥ EVA 4, reintervention).
Measured: 30 days
Pain intensity
Pain intensity measured using the Visual Analog Scale for pain (VAS), a 0-10 scale where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Higher scores reflect worse pain. Pain will be assessed at 24-48 hours and on postoperative day 7
Measured: 7 days
recurrence
Reappearance of drainage, fistulous orifices, or need for a new procedure after initial healing
Measured: 90 days
Need for local wound care
Number of dressing visits at hospital or primary care center
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Asensio Gomez, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260643
- Sponsor's protocol ID
- Hospital Universitario La Paz
- Acronym
- SiLaC-LaPaz
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study uses anonymized clinical data stored in institutional repositories at Hospital Universitario La Paz/IdiPAZ. Data access is restricted to the research team in compliance with EU Regulation 2016/679 (GDPR) and Spanish data protection law.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07260643
- Acronym / sponsor ID
- SiLaC-LaPaz / Hospital Universitario La Paz
- Conditions
- Pilonidal Sinus Disorder, Pilonidal Cyst Without Abscess, Pilonidal Sinus, Pilonidal Cysts, Pilonidal Sinus Treatment
- Keywords
- Pilondal sinus, Pilonidal Cyst, SilaC, laser-assisted closure, minimal invasive surgery, coloproctology, postoperative recovery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pilonidal sinus disease (PSD) represents a chronic, recurrent inflammatory disorder of the natal cleft that primarily affects young males. It is associated with risk factors such as obesity, prolonged sitting, and deep gluteal folds. Although not life-threatening, PSD significantly affects quality of life and healthcare resources due to recurrences and delayed wound healing.
Conventional surgical approaches, including excision with secondary healing or flap reconstruction (Limberg, Karydakis, Bascom), often require prolonged recovery and intensive postoperative care. Minimally invasive alternatives have been developed to improve patient recovery and reduce morbidity. Among them, the SiLaC® (Sinus Laser-Assisted Closure) technique employs a radial 1470-nm diode laser fiber to achieve epithelial destruction and tract contraction after curettage. Early evidence suggests favorable outcomes, but robust prospective data remain scarce, especially in Spain.
This study is an ambispective, descriptive, single-center cohort conducted at Hospital Universitario La Paz, Madrid. It includes all adult patients (≥18 years) who undergo SiLaC® surgery for chronic pilonidal sinus between August 2024 and January 2026. Data will be collected retrospectively from electronic health records and prospectively during follow-up visits and structured interviews.
The primary outcome is the total recovery time perceived by the patient (days from surgery to full return to normal activities).
Secondary outcomes include postoperative complications (minor or major), pain intensity (EVA 0-10), wound infection, recurrence within 6 months, patient satisfaction (0-10 scale), and number of wound care visits.
Data will be anonymized and analyzed descriptively using R software (version 4.3.1). Normality will be assessed with the Kolmogorov-Smirnov test; comparisons will use Student's t-test, Mann-Whitney, ANOVA, or Chi-square as appropriate. A significance level of p < 0.05 will be applied.
The study poses no additional risk, as SiLaC® is part of routine surgical practice. Ethical approval will be obtained from the Institutional Ethics Committee (CEIm of Hospital Universitario La Paz / IdiPAZ). Patient confidentiality will be guaranteed under EU Regulation 2016/679 and Spanish Law 3/2018.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SilaC | – | Procedure: SilaCSingle cohort including all consecutive adult patients operated on using the SiLaC technique between August 2024 and January 2026. Data collected retrospectively and prospectively from clinical records and follow-up interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with chronic pilonidal sinus disease who undergo laser-assisted closure (SiLaC®) at the Department of General and Digestive Surgery, Coloproctology Section, Hospital Universitario La Paz (Madrid, Spain). Participants will be included consecutively between August 2024 and January 2026, with a minimum follow-up of 6 months after surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilaCThe 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. | Procedure or surgery | SilaC |
Primary outcome
Total perceived recovery time
Time frame: 90 days
Number of days from surgery to full return to normal activities, as reported by the patient during follow-up interviews
4 secondary outcomes
Postoperative complications
Time frame: 30 days
Pain intensity
Time frame: 7 days
recurrence
Time frame: 90 days
Need for local wound care
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study uses anonymized clinical data stored in institutional repositories at Hospital Universitario La Paz/IdiPAZ. Data access is restricted to the research team in compliance with EU Regulation 2016/679 (GDPR) and Spanish data protection law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus Disorder and Pilonidal Cyst Without Abscess, run by Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Asensio-Gomez, Consultant (0034 91727000, lasensio@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total perceived recovery time (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.