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Reduction Dead Space Volume With Karydakis Modification

Effects of Reduction Dead Space Volume With Karydakis Modification

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02574936
Enrollment
80
Registered
2015-10-14
Start date
2014-01-31
Completion date
2015-09-30
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PILONIDAL SINUS

Keywords

karydakis modification, pilonidal sinus, complication

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.

Interventions

PROCEDUREA 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

Sponsors

Harran University
CollaboratorOTHER
Siverek Devlet Hastanesi
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery18 monthsOUTCOME MEASURE: 1. Extracted sinus volume 2. The number of patients with complications 1. Delayed wound healing 2. seroma 3. hematoma formation 4. wound infection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026