Crystallized Phenol Treatment in Pilonidal Sinus
Primary Purpose
Pilonidal Sinus of Natal Cleft, Pilonidal Sinus Without Abscess
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Crystallized phenol application
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus of Natal Cleft focused on measuring pilonidal disease, crystallized phenol, outcomes
Eligibility Criteria
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:
- 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.
Sites / Locations
- Gulhane Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Successful treatment
Treatment failure
Arm Description
Patients with successfully treated pilonidal sinus disease
Pilonidal sinus disease patients with treatment failure
Outcomes
Primary Outcome Measures
Short-term recurrence rate
To evaluate short-term recurrence rates of pilonidal disease treated with crystallized phenol.
Healing time
To evaluate the mean time from initial treatment to healing the sinus
Secondary Outcome Measures
Long-term recurrence rates
To evaluate long-term recurrence rates of pilonidal disease treated with crystallized phenol.
Full Information
NCT ID
NCT04681443
First Posted
December 17, 2020
Last Updated
March 16, 2022
Sponsor
Gulhane Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04681443
Brief Title
Crystallized Phenol Treatment in Pilonidal Sinus
Official Title
Factors Affecting Outcomes of Crystallized Phenol Application in the Treatment of Pilonidal Sinus Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus of Natal Cleft, Pilonidal Sinus Without Abscess
Keywords
pilonidal disease, crystallized phenol, outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Successful treatment
Arm Type
Active Comparator
Arm Description
Patients with successfully treated pilonidal sinus disease
Arm Title
Treatment failure
Arm Type
Active Comparator
Arm Description
Pilonidal sinus disease patients with treatment failure
Intervention Type
Drug
Intervention Name(s)
Crystallized phenol application
Intervention Description
Crystallized phenol application into the sinus tract
Primary Outcome Measure Information:
Title
Short-term recurrence rate
Description
To evaluate short-term recurrence rates of pilonidal disease treated with crystallized phenol.
Time Frame
30 days
Title
Healing time
Description
To evaluate the mean time from initial treatment to healing the sinus
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Long-term recurrence rates
Description
To evaluate long-term recurrence rates of pilonidal disease treated with crystallized phenol.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suleyman Utku Celik, MD
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/20357505/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/21982072/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/23929010/
Description
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
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Crystallized Phenol Treatment in Pilonidal Sinus
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