Reduction Dead Space Volume With Karydakis Modification

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A new surgical technique

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

Other names: Modified Karydakis

Primary outcomes

Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery

Time frame: 18 months
OUTCOME MEASURE:
- Extracted sinus volume
- The number of patients with complications
- Delayed wound healing
- seroma
- hematoma formation
- wound infection

Sponsors and collaborators

Lead sponsor

Siverek Devlet Hastanesi

Other

Collaborators

Harran University

Registry information

Official study title

Effects of Reduction Dead Space Volume With Karydakis Modification

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 14, 2015
Registry last updated: Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed