Asymmetric Primary Closure and Additional Skin Excision Technique.

Study Overview
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Brief Summary
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The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

Detailed Description
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All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia. In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl. In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally. In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group. Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Official Title
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A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.

Conditions
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Pilonidal Sinus, Pilonidal Disease of Natal Cleft, Surgical Technique

Intervention / Treatment
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* Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique
* Procedure: Standard Karydakis technique.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients between age of 18-65 who had chronic pilonidal disease Exclusion Criteria: Patients who did not accept the procedure Patients had undergone previous pilonidal sinus surgery Patientshad active infection Patients who were not minimum of 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision). In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume. | Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique<br>* In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.<br>|
| Active Comparator: Group 2<br>Group 2 were treated with the standard Karydakis technique. | Procedure: Standard Karydakis technique.<br>* In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative complications. | wound dehiscence, formation of seroma, hematoma, wound infection | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Karydakis modification, pilonidal sinus, seroma