Asymmetric Primary Closure and Additional Skin Excision Technique.

NCT03424057 | Completed

• 1 other identifier: 74059997.050.01.04/79
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pilonidal Sinus; Pilonidal Disease of Natal Cleft; Surgical Technique

Keywords

Karydakis modification; pilonidal sinus; seroma

Outcome Measures

Primary Outcomes (1)

• Early postoperative complications.

  wound dehiscence, formation of seroma, hematoma, wound infection

  3 years

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision). 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.

Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique

Group 2

ACTIVE COMPARATOR

Group 2 were treated with the standard Karydakis technique.

Procedure: Standard Karydakis technique.

Interventions

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.

Group 1

Standard Karydakis technique. PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siverek Devlet Hastanesi: lead

MeSH Terms

Conditions

Pilonidal Sinus; Seroma

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgeon

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: April 15, 2015
• Primary Completion: March 25, 2016
• Study Completion: April 15, 2016
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR