Asymmetric Primary Closure and Additional Skin Excision Technique.
Primary Purpose
Pilonidal Sinus, Pilonidal Disease of Natal Cleft, Surgical Technique
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Asymmetric Primary Closure and Additional Skin Excision Technique
Standard Karydakis technique.
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring Karydakis modification, pilonidal sinus, seroma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
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.
Group 2 were treated with the standard Karydakis technique.
Outcomes
Primary Outcome Measures
Early postoperative complications.
wound dehiscence, formation of seroma, hematoma, wound infection
Secondary Outcome Measures
Full Information
NCT ID
NCT03424057
First Posted
January 30, 2018
Last Updated
February 3, 2018
Sponsor
Siverek Devlet Hastanesi
1. Study Identification
Unique Protocol Identification Number
NCT03424057
Brief Title
Asymmetric Primary Closure and Additional Skin Excision Technique.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
March 25, 2016 (Actual)
Study Completion Date
April 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siverek Devlet Hastanesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus, Pilonidal Disease of Natal Cleft, Surgical Technique
Keywords
Karydakis modification, pilonidal sinus, seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 were treated with the standard Karydakis technique.
Intervention Type
Procedure
Intervention Name(s)
Asymmetric Primary Closure and Additional Skin Excision Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Karydakis technique.
Intervention Description
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method
Primary Outcome Measure Information:
Title
Early postoperative complications.
Description
wound dehiscence, formation of seroma, hematoma, wound infection
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study has been completed. The datas will be shared as an article
Learn more about this trial
Asymmetric Primary Closure and Additional Skin Excision Technique.
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