Reduction Dead Space Volume With Karydakis Modification

Not Applicable

Completed

• Conditions: PILONIDAL SINUS
• Interventions: Procedure: A new surgical technique

• Registration Number: NCT02574936
• Lead Sponsor: Siverek Devlet Hastanesi

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-13
• Last Update Submitted: 2015-10-13
• Study First Posted: 2015-10-14
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified Karydakis,surgical technique	A new surgical technique	a new surgical technique(modified Karydakis) to be compared with standard Karydakis

Primary Outcome Measures

Name	Time	Method
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery	18 months	OUTCOME MEASURE: 1. Extracted sinus volume; 2. The number of patients with complications; 1. Delayed wound healing; 2. seroma; 3. hematoma formation; 4. wound infection