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CompletedNCT04681443Updated Mar 18, 2022

Crystallized Phenol Treatment in Pilonidal Sinus

A Phase 4 interventional study of Crystallized phenol application in Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, sponsored by Gulhane Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Gulhane Training and Research Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2018, registered Dec 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Pilonidal sinus disease is an acquired disorder of the natal cleft and its incidence is reported as 6 in 100,000. Although there are many opinions regarding the treatment of pilonidal sinus disease in the literature, surgery is the main treatment method. Regardless of the treatment protocol, this disease has a certain risk of recurrence. Therefore, the ideal treatment procedure for the pilonidal disease should be simple to perform, should allow patients to return earlier to work, should be associated with minimal pain, and should minimize financial cost.

Phenol application into the pilonidal sinus is an additional nonoperative adjunct to treatment. This method is typically used after all hair and debris have been removed or curetted from the sinus, and it helps to eliminate granulation tissue and further debris formation. The injection is followed by hair control and strict hygiene. The use of phenol causes an intense inflammatory reaction which destroys the epithelial lining, and care should be taken to protect the surrounding skin. Pain is intense and may require inpatient admission for pain control but success rates have been reported to range from 60% to 95%. However, it is difficult to know which patients can expect enough benefit from phenol application.

The aim of the study is to evaluate the factors affecting the outcomes of patients with the pilonidal disease treated with crystallized phenol and to evaluate long-term recurrence rates of pilonidal disease treated with crystallized phenol.

Read the detailed description

Pilonidal sinus disease is an acquired disorder of the natal cleft and its incidence is reported as 6 in 100,000. Although there are many opinions regarding the treatment of pilonidal sinus disease in the literature, surgery is the main treatment method. Regardless of the treatment protocol, this disease has a certain risk of recurrence. Therefore, the ideal treatment procedure for the pilonidal disease should be simple to perform, should allow patients to return earlier to work, should be associated with minimal pain, and should minimize financial cost.

Phenol application into the pilonidal sinus is an additional nonoperative adjunct to treatment. This method is typically used after all hair and debris have been removed or curetted from the sinus, and it helps to eliminate granulation tissue and further debris formation. The injection is followed by hair control and strict hygiene. The use of phenol causes an intense inflammatory reaction which destroys the epithelial lining, and care should be taken to protect the surrounding skin. Pain is intense and may require inpatient admission for pain control but success rates have been reported to range from 60% to 95%. However, it is difficult to know which patients can expect enough benefit from phenol application.

In this study, the procedure will be performed on an outpatient basis and the treatment procedure will be performed in the prone position. Previously shaved sacrococcygeal area will be cleaned with an antiseptic solution and local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline). After sinuses are dilated with a mosquito clamp; hair, debris, and granulation tissue will be removed from the sinus tracts using a curved surgical forceps and the tracts will be curetted using a straight curette. Following the protection of the skin surrounding the sinus openings with a pomade and the perianal area with a sponge, the sinus cavity will be sclerosed using crystallized phenol. Crystallized phenol will be inserted into the sinus tract from the dilated sinus opening with a clamp until the tract is full. This procedure will repeat twice and each phenol particles will remain in sinus about one minute, and then will be removed by applying pressure. Consequently, the procedure will be completed after dressing and the patient will be sent home by prescribing an analgesic pill (paracetamol 500 mg) to use only when required.

After the patients are divided into two groups: (1) those successfully treated and (2) those with treatment failure, descriptive statistics will be presented as the means +/- standard deviations (SDs), medians and interquartile ranges (IQRs), and frequencies (%). Examinations of normal distribution assumptions for continuous variables will be visually assessed with quartile-quartile plots and histograms and confirmed with the Shapiro-Wilk test. Associations between variables will be evaluated using the Mann-Whitney U and Student's t tests (for continuous variables) or Pearson's chi-square and Fisher exact tests (for categorical variables), where appropriate.

The association of treatment success with demographics, symptom duration, and pilonidal sinus features such as the number and location of the sinuses, the amount of hair inside the sinus, the volume of the sinus tract, and the length of sinus tract will be analyzed with logistic regression analysis. First, each covariate will be analyzed in a univariate model, and all variables with p-value less than 0.20 will be included in the final multivariate logistic regression model to determine independent factors. Odds ratios (ORs) of statistically significant predictors will be presented with 95% confidence intervals (CIs). P values lower than 0.05 will be considered statistically significant.

02

Conditions studied

  • Pilonidal Sinus of Natal Cleft
  • Pilonidal Sinus Without Abscess

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Keywords

  • pilonidal disease
  • crystallized phenol
  • outcomes
03

In context

Pilonidal Sinus

107 studies on the registry are indexed under Pilonidal Sinus; 31 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 73 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Gulhane Training and Research Hospital is the lead sponsor of 44 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with symptoms due to chronic primary or recurring pilonidal sinus disease interfering with daily life
  • Patients giving written informed consent
  • Patients who can be contacted by e-mail or telephone
  • Patients aged 18 years and older

Exclusion criteria

Exclusion Criteria:

  • Patients with no or minimal symptoms related to pilonidal sinus disease
  • Patients with an acute pilonidal abscess or complex, multiple recurrent pilonidal diseases
  • Patients who could not be contacted during the follow-up period.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Successful treatment

    Patients with successfully treated pilonidal sinus disease

    Drug: Crystallized phenol application

  • Active comparator
    Treatment failure

    Pilonidal sinus disease patients with treatment failure

    Drug: Crystallized phenol application

Interventions

  • DrugCrystallized phenol application

    Crystallized phenol application into the sinus tract

06

What researchers measure

Primary outcomes

  1. Short-term recurrence rate

    To evaluate short-term recurrence rates of pilonidal disease treated with crystallized phenol.

    Time frame: 30 days

  2. Healing time

    To evaluate the mean time from initial treatment to healing the sinus

    Time frame: 1 year

Secondary outcomes

  1. Long-term recurrence rates

    To evaluate long-term recurrence rates of pilonidal disease treated with crystallized phenol.

    Time frame: 1 year

07

Study locations

1 site
  • Gulhane Training and Research Hospital
    Ankara, 06010, Turkey
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04681443
Lead sponsor
Gulhane Training and Research Hospital
Responsible party
Suleyman Utku Celik (Principal Investigator, Gulhane Training and Research Hospital) — Principal investigator
First posted
Dec 23, 2020
Start date
Jan 1, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Mar 18, 2022

Study contacts

Suleyman Utku Celik, MD
principal investigator · Gulhane Training and Research Hospital

Oversight

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

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