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Pilonidal Sinus of Natal CleftPhase 4NCT04681443

Crystallized Phenol Treatment in Pilonidal Sinus

A Phase 4 study testing Crystallized phenol application in people with Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Crystallized phenol application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 31 Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gulhane Training and Research Hospital

    Ankara, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Factors Affecting Outcomes of Crystallized Phenol Application in the Treatment of Pilonidal Sinus Disease

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.

Being tested
Crystallized phenol application
Keywords
pilonidal disease, crystallized phenol, outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crystallized phenol applicationDrug

    Crystallized phenol application into the sinus tract

Study groups in NCT04681443
Study groupRoleWhat they receive
Successful treatmentActive comparatorPatients with successfully treated pilonidal sinus disease
Receives: Drug: Crystallized phenol application
Treatment failureActive comparatorPilonidal sinus disease patients with treatment failure
Receives: Drug: Crystallized phenol application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term recurrence rate

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

    Measured: 30 days

  2. Healing time

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

    Measured: 1 year

Secondary outcomes (1)
  1. Long-term recurrence rates

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681443
Sponsor's protocol ID
Gulhane2020-146
Status last verified
Mar 2022
First submitted
17 Dec 2020
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Crystallized phenol application in people with Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, run by Gulhane Training 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 4 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: finished, as of the sponsor's last update on 18 Mar 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Short-term recurrence rate (time frame: 30 days). 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?
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 18 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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