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Laser Ablation vs Fibrin Glue for Pilonidal Sinus Disease

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What is being tested

surgery + laser

+ surgery + fibrine glue

Procedure
Who is being recruted

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorHelsinki University Central Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2023

Actual date on which the first participant was enrolled.

This study is examining two minimally invasive treatment methods for pilonidal sinus disease, a condition where a painful cyst or abscess forms near the tailbone. The research takes place across four hospitals in Finland and involves adults aged 18 and older who have symptoms of this disease. The aim is to find out which treatment, either laser ablation or fibrin glue, is more effective in healing the condition. This research is important because it could lead to better treatment options, quicker recovery times, and improved quality of life for those affected by this uncomfortable condition. Participants in the study are randomly assigned to receive either laser ablation or fibrin glue treatment on the day of their surgery. Researchers then assess the healing progress two months after the surgery. They also track other factors like any postoperative complications, how long patients need to take off work, the time it takes to resume their usual activities, and how often the condition returns. Additionally, they analyze how these treatments and the disease itself impact the patients' quality of life. The study also considers risk factors such as obesity, body hair, smoking habits, and related health issues like diabetes. By involving 94 patients in each treatment group, the study aims to gather enough information to determine the best treatment approach.

Official TitleLaser Ablation Versus Fibrin Glue in Mini-invasive Pilonidal Sinus Disease Surgery: a Prospective Randomized Controlled Trial
NCT06964763
Principal SponsorHelsinki University Central Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

188 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
primary pilonidal sinus disease

age 18 and above

3 exclusion criteria prevent from participating
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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
surgery + laser ablation

Group II

Active Comparator
surgery + fibrine glue

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

HUS Vatsakeskus Abdominal Center of Helsinki University Hospital

Helsinki, FinlandOpen HUS Vatsakeskus Abdominal Center of Helsinki University Hospital in Google Maps
Enrolling by invitationOne Study Center