Asymmetric Primary Closure and Additional Skin Excision Technique.

Not Applicable

Completed

• Conditions: Pilonidal Sinus; Pilonidal Disease of Natal Cleft; Surgical Technique
• Interventions: Procedure: Standard Karydakis technique.; Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique

• Registration Number: NCT03424057
• Lead Sponsor: Siverek Devlet Hastanesi

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-04-15
• Primary Completion: 2016-03-25
• Study Completion: 2016-04-15
• Study First Submitted: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-03
• Last Update Submitted: 2018-02-03
• Study First Posted: 2018-02-06
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Standard Karydakis technique.	Group 2 were treated with the standard Karydakis technique.
Group 1	Asymmetric Primary Closure and Additional Skin Excision Technique	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.

Primary Outcome Measures

Name	Time	Method
Early postoperative complications.	3 years	wound dehiscence, formation of seroma, hematoma, wound infection