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Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study


N/A
18 Years
65 Years
Open (Enrolling)
Both
Pilonidal Sinus

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Trial Information

Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study


Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and
mostly effect young males causing loss of labor and school time. Its incidence is reported
26 per 100000 in a Norwegian study. Although there are many treatment modalities either
surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques
such as limberg flap, modified limberg flap and karydakis are most popular treatment methods
for pilonidal disease crystallized phenol application is also successfully used for
pilonidal sinus treatment by different centers. We would like to compare flap techniques and
crystallized phenol application for complications, recurrence, patient comfort, duration of
recovery and return to work. We believe crystallized phenol application could become a good
alternative to popular surgical interventions using transposition flaps.


Inclusion Criteria:



- Patients with pilonidal disease

Exclusion Criteria:

- Previous history of pilonidal disease treatment

- Pregnant or breast-feeding women

- Systemic diseases that would affect wound healing

- Diabetes

- Chronic renal failure

- Autoimmune diseases

- Malignant diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Assessment of recurrence

Outcome Description:

Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.

Outcome Time Frame:

3rd year

Safety Issue:

No

Principal Investigator

Osman Do─čru, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Konya Education and Research Hospital

Authority:

Turkey: Ministry of Health

Study ID:

KEAH06021301

NCT ID:

NCT01792557

Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Pilonidal Sinus
  • Pilonidal sinus
  • Crystallized phenol
  • Limberg Flap
  • Modified Limberg Flap
  • Karydakis
  • Recurrence
  • Complications
  • Recovery duration
  • Time to return to work
  • Pilonidal Sinus

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