Overview

This trial is active, not recruiting.

Condition pilonidal sinus
Treatments secondary wound healing, primary wound closure using a limberg flap
Sponsor Kantonsspital Liestal
Start date January 2006
End date August 2013
Trial size 100 participants
Trial identifier NCT01889394, UKBB 234/05

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
primary wound closure using a limberg flap
primary wound closure using a limberg flap
primary wound closure using a limberg flap
(Active Comparator)
secondary wound healing
secondary wound healing
secondary wound healing

Primary Outcomes

Measure
Inability to work
time frame: 1 year

Secondary Outcomes

Measure
Pain perioperatively and after 3 weeks
time frame: 0 and 3 weeks
Complication rate after 3 weeks
time frame: 3 weeks
Patient satisfaction after 3 weeks & 1year
time frame: 3 weeks and 1 year
Recurrence rate after 1 year
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - indication for excision of pilonidal sinus given Exclusion Criteria: - limberg flap not possible for surgical reasons

Additional Information

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
Principal investigator Christoph A Maurer, Prof Dr med
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Kantonsspital Liestal.