Reduction Dead Space Volume With Karydakis Modification

NCT ID: NCT02574936

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-30

Brief Summary

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

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.

Conditions

PILONIDAL SINUS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified Karydakis,surgical technique

a new surgical technique(modified Karydakis) to be compared with standard Karydakis

Group Type: OTHER

A new surgical technique

Intervention Type: PROCEDURE

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

Interventions

A new surgical technique

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

Intervention Type: PROCEDURE

Other Intervention Names

Modified Karydakis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harran University

OTHER

Sponsor Role: collaborator

Siverek Devlet Hastanesi

OTHER

Sponsor Role: lead

Responsible Party

Abdulcabbar Kartal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Uzunköy

Role: STUDY_DIRECTOR

Harran University

Other Identifiers

74059997.050.01.04/77

Identifier Type: -

Identifier Source: org_study_id