Back to resultsPrimary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
secondary wound healing
primary wound closure using a limberg flap
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring pilonidal sinus, excision, primary wound closure, limberg flap
Eligibility Criteria
Inclusion Criteria:
- indication for excision of pilonidal sinus given
Exclusion Criteria:
- limberg flap not possible for surgical reasons
Sites / Locations
- Gesundheitszentrum Fricktal
- Kantonsspital Liest
- Spitalzentrum Oberwallis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
limberg flap
secondary wound healing
Arm Description
primary wound closure using a limberg flap
secondary wound healing
Outcomes
Primary Outcome Measures
Inability to work
change for capacity for work at one year post-OP
Secondary Outcome Measures
Pain perioperatively and after 3 weeks
Complication rate after 3 weeks
Patient satisfaction after 3 weeks & 1year
Recurrence rate after 1 year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01889394
Brief Title
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
Official Title
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Liestal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.
Detailed Description
Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
pilonidal sinus, excision, primary wound closure, limberg flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
limberg flap
Arm Type
Active Comparator
Arm Description
primary wound closure using a limberg flap
Arm Title
secondary wound healing
Arm Type
Active Comparator
Arm Description
secondary wound healing
Intervention Type
Procedure
Intervention Name(s)
secondary wound healing
Intervention Description
secondary wound healing
Intervention Type
Procedure
Intervention Name(s)
primary wound closure using a limberg flap
Intervention Description
primary wound closure using a limberg flap
Primary Outcome Measure Information:
Title
Inability to work
Description
change for capacity for work at one year post-OP
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain perioperatively and after 3 weeks
Time Frame
0 and 3 weeks
Title
Complication rate after 3 weeks
Time Frame
3 weeks
Title
Patient satisfaction after 3 weeks & 1year
Time Frame
3 weeks and 1 year
Title
Recurrence rate after 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
indication for excision of pilonidal sinus given
Exclusion Criteria:
limberg flap not possible for surgical reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph A Maurer, Prof Dr med
Organizational Affiliation
Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gesundheitszentrum Fricktal
City
Rheinfelden
State/Province
AG
Country
Switzerland
Facility Name
Kantonsspital Liest
City
Liestal
State/Province
BL
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Spitalzentrum Oberwallis
City
Visp
State/Province
VS
ZIP/Postal Code
3930
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
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