Sacrococcygeal Pilonidal Sinus DiseasePSD-L-FNCT07701772
LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE
A study testing Laser Ablation and Crystallized phenol application in people with Sacrococcygeal Pilonidal Sinus Disease and Pilonidal Sinus Disease, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacrococcygeal Pilonidal Sinus Disease, Pilonidal Sinus Disease
- What is being tested?
- Laser Ablation and Crystallized phenol application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
- Uncomplicated disease
- Suitability for minimally invasive treatment
- Provision of written informed consent
Who cannot join
- Acute pilonidal abscess
- History of pilonidal abscess drainage
- Previous surgical or interventional treatment for pilonidal sinus disease
- Recurrent pilonidal disease
- Complex pilonidal disease or marked lateral extension
- Immunosuppression, chronic steroid use, or systemic conditions that may significantly impair wound healing
- Inability to attend regular follow-up
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa
Vedat Kaplan, +905459045165, vedat_kaplan_@hotmail.com
About this study
Official title: A PROSPECTIVE RANDOMIZED COMPARISON OF LASER ABLATION AND CRYSTALLIZED PHENOL APPLICATION IN PRIMARY UNCOMPLICATED SACROCOCCYGEAL PILONIDAL SINUS DISEASE
This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Secondary objectives include complete epithelialization by day 30, time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and 6-month recurrence.
Read the detailed description
This is a single-center, prospective, 1:1 parallel-group randomized clinical trial in adults with primary uncomplicated chronic sacrococcygeal pilonidal sinus disease. A total of 120 participants are planned, with 60 assigned to laser ablation and 60 assigned to crystallized phenol treatment. Randomization will be performed using computer-generated variable blocks, with stratification by pit number and Guner stage when feasible. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. In both groups, a small incision of approximately 1 cm will be made, hair and debris within the sinus cavity will be removed, and curettage will be performed. After these shared preparation steps, the intervention group will receive Leonardo Mini 1470 nm diode laser treatment and the comparison group will receive crystallized phenol application. Repeat sessions with the same assigned treatment may be performed when needed within the secondary healing protocol. The primary endpoint is postoperative day 1 pain intensity measured by Visual Analog Scale. The main secondary endpoint is complete epithelialization at day 30. Other secondary outcomes include time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and recurrence at 6 months.
- Being tested
- Laser Ablation, Crystallized phenol application
- Keywords
- Pilonidal sinus disease, Laser ablation, Crystallized phenol, Randomized trial, Postoperative pain, Recurrence, Complete epithelialization
- Medical subject headings
- Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AblationProcedure or surgery
After a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser.
Crystallized phenol applicationProcedure or surgery
After a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity.
| Study group | Role | What they receive |
|---|---|---|
| Laser ablation | Experimental | Participants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser. Receives: Procedure: Laser Ablation |
| Crystallized phenol | Active comparator | Participants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity. Receives: Procedure: Crystallized phenol application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative day 1 pain score
Pain intensity on postoperative day 1 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Measured: Postoperative day 1
Secondary outcomes (8)
Complete epithelialization at day 30
Presence or absence of complete epithelialization of the wound at postoperative day 30.
Measured: Postoperative day 30
Time to complete epithelialization
Time from treatment to complete epithelialization, measured in days.
Measured: Up to 30 days
Postoperative day 7 pain score
Pain intensity on postoperative day 7 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
Measured: Postoperative day 7
Duration of analgesic use
Duration of postoperative analgesic use, measured in days.
Measured: Up to 30 days
Time to return to daily activities
Time required to return to normal daily activities, measured in days.
Measured: Up to 30 days
Time to return to work
Time required to return to work, measured in days.
Measured: Up to 30 days
Incidence of early local complications
Number and proportion of participants who develop any early local postoperative complication.
Measured: Within 30 days after treatment
Recurrence at 6 months
Presence or absence of recurrent pilonidal sinus disease by 6 months after treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacrococcygeal Pilonidal Sinus DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either laser ablation or crystallized phenol treatment in a parallel-group design.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Kaplan, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701772
- Sponsor's protocol ID
- SEAH-PİSİ
- Acronym
- PSD-L-F
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 1 Sep 2026
- 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 because this is a single-center clinical study involving sensitive patient-level data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE RANDOMIZED COMPARISON OF LASER ABLATION AND CRYSTALLIZED PHENOL APPLICATION IN PRIMARY UNCOMPLICATED SACROCOCCYGEAL PILONIDAL SINUS DISEASE
- ClinicalTrials.gov ID
- NCT07701772
- Acronym / sponsor ID
- PSD-L-F / SEAH-PİSİ
- Keywords
- Pilonidal sinus disease, Laser ablation, Crystallized phenol, Randomized trial, Postoperative pain, Recurrence, Complete epithelialization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
This single-center prospective randomized parallel-group trial compares laser ablation and crystallized phenol application in adults with primary uncomplicated sacrococcygeal pilonidal sinus disease. The primary objective is to compare postoperative day 1 pain intensity between the two treatment methods. Secondary objectives include complete epithelialization by day 30, time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and 6-month recurrence.
Detailed description
This is a single-center, prospective, 1:1 parallel-group randomized clinical trial in adults with primary uncomplicated chronic sacrococcygeal pilonidal sinus disease. A total of 120 participants are planned, with 60 assigned to laser ablation and 60 assigned to crystallized phenol treatment. Randomization will be performed using computer-generated variable blocks, with stratification by pit number and Guner stage when feasible. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. In both groups, a small incision of approximately 1 cm will be made, hair and debris within the sinus cavity will be removed, and curettage will be performed. After these shared preparation steps, the intervention group will receive Leonardo Mini 1470 nm diode laser treatment and the comparison group will receive crystallized phenol application. Repeat sessions with the same assigned treatment may be performed when needed within the secondary healing protocol. The primary endpoint is postoperative day 1 pain intensity measured by Visual Analog Scale. The main secondary endpoint is complete epithelialization at day 30. Other secondary outcomes include time to complete epithelialization, postoperative day 7 pain, duration of analgesic use, time to return to daily activities and work, early local complications, and recurrence at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either laser ablation or crystallized phenol treatment in a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| Laser ablation | Experimental | Procedure: Laser AblationParticipants undergo shared sinus preparation followed by laser ablation using a Leonardo Mini 1470 nm diode laser. |
| Crystallized phenol | Active comparator | Procedure: Crystallized phenol applicationParticipants undergo shared sinus preparation followed by crystallized phenol application to the sinus cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Diagnosis of primary chronic sacrococcygeal pilonidal sinus disease
- Uncomplicated disease
- Suitability for minimally invasive treatment
- Provision of written informed consent
Key exclusion criteria (8 listed)
- Acute pilonidal abscess
- History of pilonidal abscess drainage
- Previous surgical or interventional treatment for pilonidal sinus disease
- Recurrent pilonidal disease
- Complex pilonidal disease or marked lateral extension
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 |
|---|---|---|
| Laser AblationAfter a small incision, hair and debris removal, and curettage, laser ablation is performed using a Leonardo Mini 1470 nm diode laser. | Procedure or surgery | Laser ablation |
| Crystallized phenol applicationAfter a small incision, hair and debris removal, and curettage, crystallized phenol is applied to the sinus cavity. | Procedure or surgery | Crystallized phenol |
Primary outcome
Postoperative day 1 pain score
Time frame: Postoperative day 1
Pain intensity on postoperative day 1 assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
8 secondary outcomes
Complete epithelialization at day 30
Time frame: Postoperative day 30
Time to complete epithelialization
Time frame: Up to 30 days
Postoperative day 7 pain score
Time frame: Postoperative day 7
Duration of analgesic use
Time frame: Up to 30 days
Time to return to daily activities
Time frame: Up to 30 days
Time to return to work
Time frame: Up to 30 days
Incidence of early local complications
Time frame: Within 30 days after treatment
Recurrence at 6 months
Time frame: 6 months
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 1 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a single-center clinical study involving sensitive patient-level data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Ablation and Crystallized phenol application in people with Sacrococcygeal Pilonidal Sinus Disease and Pilonidal Sinus Disease, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Vedat Kaplan (+905459045165, vedat_kaplan_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative day 1 pain score (time frame: Postoperative day 1). 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 1 Sep 2026.