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Completed

NCT Number: NCT03424057

Asymmetric Primary Closure and Additional Skin Excision Technique.

The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients between age of 18-65 who had chronic pilonidal disease

Exclusion criteria

  • Patients who did not accept the procedure
  • Patients had undergone previous pilonidal sinus surgery
  • Patientshad active infection
  • Patients who were not minimum of 18 years of age

Treatment and study plan

Asymmetric Primary Closure and Additional Skin Excision Technique

Procedure

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

Standard Karydakis technique.

Procedure

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method

Primary outcomes

  1. Early postoperative complications.

    Time frame: 3 years

    wound dehiscence, formation of seroma, hematoma, wound infection

Sponsors and collaborators

Lead sponsor

Siverek Devlet Hastanesi

Other

Registry information

Official study title

A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2018
Registry last updated
Feb 6, 2018

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.

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