Pilonidal DiseaseNCT06964763
A Trial in Mini-invasive Pilonidal Sinus Disease Surgery
A study testing surgery + laser and surgery + fibrine glue in people with Pilonidal Disease, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Pilonidal sinus disease is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- surgery + laser and surgery + fibrine glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2023to 17 Dec 2029
- 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
- primary pilonidal sinus disease
- age 18 and above
Who cannot join
- recurrent pilonidal sinus disease
- age under 18
- inability to understand Finnish or Swedish (the questionnaires are in Finnish and Swedish only, the two official languages of Finland)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
HUS Vatsakeskus Abdominal Center of Helsinki University Hospital
Helsinki
About this study
Official title: Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
Pilonidal sinus disease is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Advantages of mini-invasive techniques include: quicker recovery and earlier return to work and high patient satisfaction. Randomized studies are rare and this applies especially to newer mini-invasive techniques. The purpose of the investigators prospective study is to randomly compare the mini-invasive laser ablation technique to the mini-invasive fibrin glue treatment in pilonidal sinus disease surgery.
Read the detailed description
This is a multicenter study comparing two mini-invasive treatmnet options in pilonidal sinus disease. The study is carried out in four hospitals in Uusimaa county of Finland (Jorvi hospital, Porvoo hospital, Lohja hospital and Hyvinkää hospital). Patients, who are 18 or above, with a symptomatic primary pilonidal sinus disease are eligible for the study. On the day of surgery, the patient is randomly assigned to one of the two surgery groups. The main variable of our study is the healing rate at 2 months after surgery. Other variables to be studied are: postoperative complications, length of sick leave, time for returning to everyday life, recurrence rate and the effects of PSD and PSD surgery on the patient's quality of life. A cost analysis will be performed. Risk factors such as overweight, pubic hair, smoking and associated diseases such as diabetes will also be analyzed. According to the power calculation, the investigators need 94 patients in each group to ensure the success of the study.
- Conditions
- Pilonidal Disease
- Being tested
- surgery + laser, surgery + fibrine glue
- Keywords
- pilonidal sinus disease, laser ablation, fibrine glue, randomized trial, prospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery + laserProcedure or surgery
laser
surgery + fibrine glueProcedure or surgery
fibrine glue
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Active comparator | surgery + laser ablation Receives: Procedure: surgery + laser |
| study group 2 | Active comparator | surgery + fibrine glue Receives: Procedure: surgery + fibrine glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
Healing rate will be assessed by a questionnaire and a phone call
Measured: 2 months after surgery
Quality of life
Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey
Measured: 2 months after surgery
Secondary outcomes (5)
Recurrence rate
Follow-up at 1, 3 and 5 years by assessing electronic medical records to reveal recurrences
Measured: 1, 3 and 5 years after surgery
Cost analysis
Compare the price for the two surgical treatments
Measured: At 2 months after surgery
Postoperative complications
Postoperative complications will be assessed by a phone call and clinical examination
Measured: 2 - 3 months after the surgery
Sick leave
Length of sick leave will be assessed by a questionnaire and medical records
Measured: 2 months and 1 year after surgery
Recovery time
The time it has taken fot the patient to return to everyday life is assessed by a questionnaire and through medical records
Measured: 2 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Sep 2023
- Primary completion17 Jun 2029 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal 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
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kethe Hermunen, Helsinki University Central Hospital
- Investigators
- Pauli Puolakkainen, Professor, Study director, University of Helsinki, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964763
- Sponsor's protocol ID
- HUS/2951/2021
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet discussed this within the study group
Publications
Koskinen K, Koppatz H, Poussa T, Harju J, Hermunen K. Glue versus Laser Ablation in Mini-invasive Pilonidal sinus surgery-the GLAMP study: a study protocol for a randomised controlled trial. Trials. 2026 Jun 13. doi: 10.1186/s13063-026-09852-8. Online ahead of print.
PubMed 42288936
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06964763
- Acronym / sponsor ID
- HUS/2951/2021
- Conditions
- Pilonidal Disease
- Keywords
- pilonidal sinus disease, laser ablation, fibrine glue, randomized trial, prospective study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 17 Jun 2029 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 9 May 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 is a chronic acquired disease leading to significant morbidity and healthcare costs in young man and women. Despite different treatment methods, the disease relatively often leads to postoperative complications and recurrence.(8). Advantages of mini-invasive techniques include: quicker recovery and earlier return to work and high patient satisfaction. Randomized studies are rare and this applies especially to newer mini-invasive techniques. The purpose of the investigators prospective study is to randomly compare the mini-invasive laser ablation technique to the mini-invasive fibrin glue treatment in pilonidal sinus disease surgery.
Detailed description
This is a multicenter study comparing two mini-invasive treatmnet options in pilonidal sinus disease. The study is carried out in four hospitals in Uusimaa county of Finland (Jorvi hospital, Porvoo hospital, Lohja hospital and Hyvinkää hospital). Patients, who are 18 or above, with a symptomatic primary pilonidal sinus disease are eligible for the study. On the day of surgery, the patient is randomly assigned to one of the two surgery groups. The main variable of our study is the healing rate at 2 months after surgery. Other variables to be studied are: postoperative complications, length of sick leave, time for returning to everyday life, recurrence rate and the effects of PSD and PSD surgery on the patient's quality of life. A cost analysis will be performed. Risk factors such as overweight, pubic hair, smoking and associated diseases such as diabetes will also be analyzed. According to the power calculation, the investigators need 94 patients in each group to ensure the success of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Active comparator | Procedure: surgery + lasersurgery + laser ablation |
| study group 2 | Active comparator | Procedure: surgery + fibrine gluesurgery + fibrine glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary pilonidal sinus disease
- age 18 and above
Key exclusion criteria (3 listed)
- recurrent pilonidal sinus disease
- age under 18
- inability to understand Finnish or Swedish (the questionnaires are in Finnish and Swedish only, the two official languages of Finland)
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 |
|---|---|---|
| surgery + laserlaser | Procedure or surgery | study group 1 |
| surgery + fibrine gluefibrine glue | Procedure or surgery | study group 2 |
Primary outcome
Healing rate
Time frame: 2 months after surgery
Healing rate will be assessed by a questionnaire and a phone call
Quality of life
Time frame: 2 months after surgery
Quality of life will be assessed by a questionnaire, the RAND 36-Item Health Survey
5 secondary outcomes
Recurrence rate
Time frame: 1, 3 and 5 years after surgery
Cost analysis
Time frame: At 2 months after surgery
Postoperative complications
Time frame: 2 - 3 months after the surgery
Sick leave
Time frame: 2 months and 1 year after surgery
Recovery time
Time frame: 2 months and 1 year after surgery
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 May 2025.
- Derived from this study: PubMed 42288936Koskinen K, Koppatz H, Poussa T, Harju J, Hermunen K. Glue versus Laser Ablation in Mini-invasive Pilonidal sinus surgery-the GLAMP study: a study protocol for a randomised controlled trial. Trials. 2026 Jun 13. doi: 10.1186/s13063-026-09852-8. Online ahead of print.
- Individual participant dataSharing planned: Undecided. We have not yet discussed this within the study group
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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.
Pauli Puolakkainen, Professor study director
University of Helsinki, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery + laser and surgery + fibrine glue in people with Pilonidal Disease, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 9 May 2025. 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 Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 2 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964763, which also lists 1 linked publication.
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 May 2025.