Crystallized Phenol Treatment in Pilonidal Sinus

NCT04681443 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-18

No results posted yet for this 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.

Conditions

  • Pilonidal Sinus of Natal Cleft
  • Pilonidal Sinus Without Abscess

Interventions

DRUG

Crystallized phenol application

Crystallized phenol application into the sinus tract

Sponsors & Collaborators

  • Gulhane Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Suleyman Utku Celik, MD · Gulhane Training and Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681443 on ClinicalTrials.gov