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CompletedNCT07369921Updated Oct 6, 2026

Pediatric Pilonidal Sinus Surgical Treatment

An interventional study of Crystallized Phenol Applied in Surgery, Pilonidal Sinus and Pediatric, sponsored by Zeliha Alicikus. Completed at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Zeliha Alicikus · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study summary

The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.

Read the detailed description

Pilonidal sinus disease (PSD) is common in young adults and causes repeated infection and inflammation in the sacrococcygeal region. It is most common in men between the ages of 20 and 30, which is why most publications about PSD are part of adult series.

This study aims to determine which treatment option is more effective and beneficial for patients with sacrococcygeal pilonidal sinus. Furthermore, it aims to contribute to more positive treatment outcomes by identifying the causes of recurrence and morbidity in patients. Sacrococcygeal pilonidal sinus is quite common in adolescents. Treatment options vary from non-operative to endoscopic surgery. However, recurrence still occurs with every technique. Patients suffer from long treatment processes and morbidity. Although the exact causes of recurrence are not fully understood, it is thought that the patient's demographic characteristics and treatment option play a role. Most studies are retrospective and compare at most two treatment options. This is one of the reasons why it is not possible to reach a definitive conclusion about which treatment is more effective. Also, the number of studies conducted in the adolescent age group is limited. By conducting study prospectively and randomized, aim to prevent biased results.

02

Conditions studied

  • Surgery
  • Pilonidal Sinus
  • Pediatric

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Keywords

  • Pilonidal Sinus
  • pediatric surgery
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Zeliha Alicikus is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • having sacrococcygeal pilonidal sinus disease
  • written informed (family) consent were eligible for inclusion in this trial

Exclusion criteria

Exclusion Criteria:

  • Being over 18 years old or under 12 years old
  • recurrent sacrococcygeal pilonidal sinus disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Crystallized Phenol Applied Group (Group P) n:21

    the pilonidal sinus (PS) periphery was cleaned using an antiseptic solution. A clamp was used to widen the sinus opening. The sinuses were thoroughly cleansed. Hair and granulation tissue were removed by curettage. Nitrofurantoin pomade (FurocinR Eczacıbaşı Istanbul, Turkey) was applied around the sinus to protect it from burns. Sufficient crystallized phenol (BotaFarma Medical Ankara, Turkey) was applied to fill the cavity (approximately 3-5 gr). Because crystallized phenol liquefies as soon as it contacts the body, it was compressed with a sponge for two minutes to prevent disintegration. The sinus opening was closed with ointment. Patients were hospitalized for one day.

    Procedure: Crystallized Phenol Applied

  • Active comparator
    Endoscopy Group (Group EPSiT) n:22

    The main sinus was enlarged to an initial width of 5 mm through which the pediatric cystoscope can pass. We utilized a 1% mannitol solution for sinus irrigation. The hair follicles and necrotic tissues were eliminated. Then, the sinus was effectively cauterized using a monopolar probe. The inside of the sinus was cleaned with a brush

    Procedure: Crystallized Phenol Applied

  • Active comparator
    Limberg Flap Group (Group L) n:23

    The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.

    Procedure: Crystallized Phenol Applied

  • Active comparator
    Modified Limberg Flap Group (Group ML) n:22

    The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.

    Procedure: Crystallized Phenol Applied

Interventions

  • ProcedureCrystallized Phenol Applied

    four different surgical methods for the treatment of sacrococcygeal pilonidal sinus

    Also known as: Endoscopy Group, Limberg Flap Group, Modified Limberg Flap Group

06

What researchers measure

Primary outcomes

  1. complications

    Recurrence

    Time frame: 30 days

  2. pain score

    VAS score under 4,VAS score above 4

    Time frame: 24 hours

Secondary outcomes

  1. sinus volume measurement

    USG guided

    Time frame: 24 hours

07

Study locations

1 site
  • Umraniye Education and Research Hospital
    Istanbul, Umraniye 34734, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Completed
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07369921
Lead sponsor
Zeliha Alicikus
Responsible party
Zeliha Alicikus (Assoc. prof. dr, Umraniye Education and Research Hospital) — Sponsor-investigator
First posted
Jan 27, 2026
Start date
Apr 30, 2026
Primary completion
Apr 30, 2026
Completion
May 30, 2026
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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