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Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods

Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02186964
Enrollment
150
Registered
2014-07-10
Start date
2011-02-28
Completion date
2014-05-31
Last updated
2014-07-10

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

Conditions

Complication, Pilonidal Disease, Recurrence

Brief summary

Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life. There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in between those methods is the closing of the defect that occurs after the excision of the sinus tract. The defect can be closed by primary sutures or it can be left for secondary healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap procedures are commonly used. However, it has been reported that there is no difference between flap procedures and tension free primary closure. This result triggered the controversy that; if the healing side is tension free, midline suturing may have no importance. The aim of this study is to compare the results of 3 different surgical procedures used in treatment of pilonidal disease.

Interventions

PROCEDUREtension free primary closure

tension free primary closure of the defects created by excision of the pilonidal sinus

PROCEDUREkarydakis

the defect after excision of the pilonidal sinus is closed by Karydakis procedure

PROCEDURELimberg flap

defect after excision of the pilonidal sinus is closed by Limberg flap procedure

Sponsors

Konya Meram State Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* having pilonidal sinus disease * desire for surgical treatment * accept to be involved in the study

Exclusion criteria

* patients under age of 18 * recurrent cases

Design outcomes

Primary

MeasureTime frameDescription
recurrence2 yearsrecurrence rates two years after the surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

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