Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2018-01-01
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nonoperative Treatment of Recurrent Pilonidal Sinus Disease
NCT04423510
Crystallized Phenol Versus Transposition Flaps for Treatment of Pilonidal Disease: A Prospective Study
NCT01792557
Phenol and Silver Nitrate Application in Pilonidal Sinus
NCT04560049
Minimally Invasive Treatment Methods for Pilonidal Disease
NCT03070028
Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment
NCT06517472
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Successful treatment
Patients with successfully treated pilonidal sinus disease
Crystallized phenol application
Crystallized phenol application into the sinus tract
Treatment failure
Pilonidal sinus disease patients with treatment failure
Crystallized phenol application
Crystallized phenol application into the sinus tract
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Crystallized phenol application
Crystallized phenol application into the sinus tract
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients giving written informed consent
* Patients who can be contacted by e-mail or telephone
* Patients aged 18 years and older
Exclusion Criteria
* Patients with an acute pilonidal abscess or complex, multiple recurrent pilonidal diseases
* Patients who could not be contacted during the follow-up period.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gulhane Training and Research Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Suleyman Utku Celik
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suleyman Utku Celik, MD
Role: PRINCIPAL_INVESTIGATOR
Gulhane Training and Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Kayaalp C, Olmez A, Aydin C, et al. Investigation of a one-time phenol application for pilonidal disease. Med Princ Pract 2010;19(3):212-5.
Dag A, Colak T, Turkmenoglu O, et al. Phenol procedure for pilonidal sinus disease and risk factors for treatment failure. Surgery 2012; 151(1):113-7.
Steele SR, Perry WB, Mills S, et al. Practice parameters for the management of pilonidal disease. Dis Colon Rectum 2013; 56(9):1021-7.. doi: 10.1097/DCR.0b013e31829d2
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Gulhane2020-146
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.