Trial | NCT01792557  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    phenol ...

  • Study Participants

    200
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.
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.
Study Started
Mar 31
2013
Primary Completion
Mar 31
2017
Anticipated
Study Completion
Mar 31
2018
Anticipated
Last Update
Mar 24
2014
Estimate

Drug Crystallized phenol

Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks.

Procedure Limberg Flap

Limberg Flap surgery for pilonidal disease treatment

Procedure Modified Limberg Flap

Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.

Procedure Karydakis Flap

Karydakis Flap surgery for pilonidal disease treatment

Phenol Active Comparator

Crystallized Phenol Group

Limberg Active Comparator

Limberg Flap Group

Modified Limberg Active Comparator

Modified Limberg Flap Group

Karydakis Active Comparator

Karydakis Flap Group

Criteria 

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
No Results Posted