Reduction Dead Space Volume With Karydakis Modification

Study Overview
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Brief Summary
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The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.

Detailed Description
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The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.

Official Title
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Effects of Reduction Dead Space Volume With Karydakis Modification

Conditions
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PILONIDAL SINUS

Intervention / Treatment
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* Procedure: A new surgical technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years patients who accept the procedure chronic p.sinüs disease Exclusion Criteria: previous sinüs surgery active infection patients who did not accept the procedure patients under age of 18.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: modified Karydakis,surgical technique<br>a new surgical technique(modified Karydakis) to be compared with standard Karydakis | Procedure: A new surgical technique<br>* Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume. A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used<br>* Other names: Modified Karydakis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery | OUTCOME MEASURE: Extracted sinus volume The number of patients with complications Delayed wound healing seroma hematoma formation wound infection | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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karydakis modification, pilonidal sinus, complication