Reduction Dead Space Volume With Karydakis Modification

PILONIDAL SINUS Clinical Trial

Official title:

Effects of Reduction Dead Space Volume With Karydakis Modification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574936
• Other study ID #: 74059997.050.01.04/77
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: October 13, 2015
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Siverek Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PILONIDAL SINUS

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Siverek Devlet Hastanesi	Harran University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery	OUTCOME MEASURE: Extracted sinus volume; The number of patients with complications; Delayed wound healing; seroma; hematoma formation; wound infection	18 months	Yes