Asymmetric Primary Closure and Additional Skin Excision Technique.

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.

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

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus; Surgical Technique; Pilonidal Disease of Natal Cleft
• Intervention / Treatment: Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique; Procedure: Standard Karydakis technique.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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; 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.
Active Comparator: Group 2; Group 2 were treated with the standard Karydakis technique.	Procedure: Standard Karydakis technique.; In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early postoperative complications.	wound dehiscence, formation of seroma, hematoma, wound infection	3 years

Collaborators and Investigators

• Sponsor: Siverek Devlet Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2015
• Primary Completion (Actual): March 25, 2016
• Study Completion (Actual): April 15, 2016

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 3, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 3, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: seroma; pilonidal sinus; Karydakis modification
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: 74059997.050.01.04/79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study has been completed. The datas will be shared as an article
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No