search
Back to results

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
Siverek Devlet Hastanesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Karydakis modification, pilonidal sinus, seroma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 30, 2018
    Last Updated
    February 3, 2018
    Sponsor
    Siverek Devlet Hastanesi
    search

    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.

    We'll reach out to this number within 24 hrs