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NCT01889394 Clinical Trial

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

Pilonidal Sinus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01889394
Other study ID # UKBB 234/05
Secondary ID
Status Completed
Phase N/A
First received June 24, 2013
Last updated August 29, 2017
Start date January 2006
Est. completion date August 2013

Study information
Verified date August 2017
Source Kantonsspital Liestal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- indication for excision of pilonidal sinus given

Exclusion Criteria:

- limberg flap not possible for surgical reasons

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• secondary wound healing
secondary wound healing
• primary wound closure using a limberg flap
primary wound closure using a limberg flap

Locations
Country Name City State
Switzerland Kantonsspital Liest Liestal BL
Switzerland Gesundheitszentrum Fricktal Rheinfelden AG
Switzerland Spitalzentrum Oberwallis Visp VS

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inability to work change for capacity for work at one year post-OP 1 year
Secondary Pain perioperatively and after 3 weeks 0 and 3 weeks
Secondary Complication rate after 3 weeks 3 weeks
Secondary Patient satisfaction after 3 weeks & 1year 3 weeks and 1 year
Secondary Recurrence rate after 1 year 1 year
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