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Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision

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ClinicalTrials.gov Identifier: NCT01889394
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Liestal

Brief Summary:
To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: secondary wound healing Procedure: primary wound closure using a limberg flap Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: limberg flap
primary wound closure using a limberg flap
Procedure: primary wound closure using a limberg flap
primary wound closure using a limberg flap

Active Comparator: secondary wound healing
secondary wound healing
Procedure: secondary wound healing
secondary wound healing




Primary Outcome Measures :
  1. Inability to work [ Time Frame: 1 year ]
    change for capacity for work at one year post-OP


Secondary Outcome Measures :
  1. Pain perioperatively and after 3 weeks [ Time Frame: 0 and 3 weeks ]
  2. Complication rate after 3 weeks [ Time Frame: 3 weeks ]
  3. Patient satisfaction after 3 weeks & 1year [ Time Frame: 3 weeks and 1 year ]
  4. Recurrence rate after 1 year [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication for excision of pilonidal sinus given

Exclusion Criteria:

  • limberg flap not possible for surgical reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889394


Locations
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Switzerland
Gesundheitszentrum Fricktal
Rheinfelden, AG, Switzerland
Kantonsspital Liest
Liestal, BL, Switzerland, 4410
Spitalzentrum Oberwallis
Visp, VS, Switzerland, 3930
Sponsors and Collaborators
Kantonsspital Liestal
Investigators
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Principal Investigator: Christoph A Maurer, Prof Dr med Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel
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Responsible Party: Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT01889394    
Other Study ID Numbers: UKBB 234/05
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Keywords provided by Kantonsspital Liestal:
pilonidal sinus
excision
primary wound closure
limberg flap
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms