Asymmetric Primary Closure and Additional Skin Excision Technique.

Siverek Devlet Hastanesi

Status: Completed

Conditions: Surgical Technique; Pilonidal Sinus; Pilonidal Disease of Natal Cleft

Treatments: Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique; Procedure: Standard Karydakis technique.

Study type: Interventional

Funder types: Other

Identifiers

NCT03424057

74059997.050.01.04/79

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique

Group 2

Active Comparator group

Description:

Group 2 were treated with the standard Karydakis technique.

Treatment:

Procedure: Standard Karydakis technique.