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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01792557
Enrollment
200
Registered
2013-02-15
Start date
2013-03-31
Completion date
2018-03-31
Last updated
2014-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

Keywords

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

Brief summary

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.

Detailed 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.

Interventions

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.

PROCEDURELimberg Flap

Limberg Flap surgery for pilonidal disease treatment

PROCEDUREModified 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.

Karydakis Flap surgery for pilonidal disease treatment

Sponsors

S.B. Konya Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of recurrence3rd yearPatients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.

Secondary

MeasureTime frameDescription
Assessment of patient comfort1st yearPatients will be queried for patient comfort at the end of first year
Assessment of recovery duration3rd monthPost procedure wound recovery duration will be recorded
Assessment of complications3rd monthPatients will be followed up for procedure related complications.

Other

MeasureTime frameDescription
Assessment of time before patient returns to work/routine physical activity3rd monthPatients will be queried for when they felt comfortable to return to work and/or their routine physical activity.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026