Asymmetric Primary Closure and Additional Skin Excision Technique.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-15

Study Completion Date

2016-04-15

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.

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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.

Conditions

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Pilonidal Sinus Pilonidal Disease of Natal Cleft Surgical Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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.

Group Type EXPERIMENTAL

Asymmetric Primary Closure and Additional Skin Excision Technique

Intervention Type PROCEDURE

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.

Group 2

Group 2 were treated with the standard Karydakis technique.

Group Type ACTIVE_COMPARATOR

Standard Karydakis technique.

Intervention Type PROCEDURE

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method

Interventions

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