Asymmetric Primary Closure and Additional Skin Excision Technique.

Pilonidal Sinus Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424057
• Other study ID #: 74059997.050.01.04/79
• Status: Completed
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 3, 2018
• Start date: April 15, 2015
• Est. completion date: April 15, 2016

Study information

• Verified date: February 2018
• Source: Siverek Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 15, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease of Natal Cleft
• Pilonidal Sinus
• Surgical Technique

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Siverek Devlet Hastanesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early postoperative complications.	wound dehiscence, formation of seroma, hematoma, wound infection	3 years