Crystallized Phenol Treatment in Pilonidal Sinus

NCT04681443 | Completed Phase 4

• 1 other identifier: Gulhane2020-146
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Sinus of Natal Cleft; Pilonidal Sinus Without Abscess

Keywords

pilonidal disease; crystallized phenol; outcomes

Outcome Measures

Primary Outcomes (2)

• Short-term recurrence rate

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

  30 days

• Healing time

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

  1 year

Secondary Outcomes (1)

• Long-term recurrence rates

  1 year

Study Arms (2)

Successful treatment

ACTIVE COMPARATOR

Patients with successfully treated pilonidal sinus disease

Drug: Crystallized phenol application

Treatment failure

ACTIVE COMPARATOR

Pilonidal sinus disease patients with treatment failure

Drug: Crystallized phenol application

Interventions

Crystallized phenol application DRUG

Crystallized phenol application into the sinus tract

Successful treatment; Treatment failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Links

• 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

Study Officials

• Suleyman Utku Celik, MD

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)