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

S

S.B. Konya Education and Research Hospital

Status

Unknown

Conditions

Pilonidal Sinus

Treatments

Procedure: Limberg Flap
Procedure: Modified Limberg Flap
Procedure: Karydakis Flap
Drug: Crystallized phenol

Study type

Interventional

Funder types

Other

Identifiers

NCT01792557
U1111-1139-3538 (Other Identifier)
KEAH06021301

Details and patient eligibility

About

Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 4 patient groups

Phenol
Active Comparator group
Description:
Crystallized Phenol Group
Treatment:
Drug: Crystallized phenol
Limberg
Active Comparator group
Description:
Limberg Flap Group
Treatment:
Procedure: Limberg Flap
Modified Limberg
Active Comparator group
Description:
Modified Limberg Flap Group
Treatment:
Procedure: Modified Limberg Flap
Karydakis
Active Comparator group
Description:
Karydakis Flap Group
Treatment:
Procedure: Karydakis Flap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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