NCT02574936

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

October 8, 2015

Last Update Submit

October 13, 2015

Conditions

PILONIDAL SINUS

Keywords

karydakis modificationpilonidal sinuscomplication

Outcome Measures

Primary Outcomes (1)

  • 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: 1. Extracted sinus volume 2. The number of patients with complications 1. Delayed wound healing 2. seroma 3. hematoma formation 4. wound infection

    18 months

Study Arms (1)

modified Karydakis,surgical technique

OTHER

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

Procedure: A new surgical technique

Interventions

A new surgical techniquePROCEDURE

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

Also known as: Modified Karydakis
modified Karydakis,surgical technique

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients older than 18 years
  • patients who accept the procedure
  • chronic p.sinüs disease

You may not qualify if:

  • previous sinüs surgery
  • active infection
  • patients who did not accept the procedure
  • patients under age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Ali Uzunköy

    Harran University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 14, 2015

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10