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

Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial

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

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: primary wound closure using a limberg flap; Procedure: secondary wound healing

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).

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • AG
    • Rheinfelden, AG, Switzerland
      • Gesundheitszentrum Fricktal
  • BL
    • Liestal, BL, Switzerland, 4410
      • Kantonsspital Liest
  • VS
    • Visp, VS, Switzerland, 3930
      • Spitalzentrum Oberwallis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• indication for excision of pilonidal sinus given

Exclusion Criteria:

• limberg flap not possible for surgical reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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	Procedure: secondary wound healing; secondary wound healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inability to work	change for capacity for work at one year post-OP	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain perioperatively and after 3 weeks	0 and 3 weeks
Complication rate after 3 weeks	3 weeks
Patient satisfaction after 3 weeks & 1year	3 weeks and 1 year
Recurrence rate after 1 year	1 year

Collaborators and Investigators

• Sponsor: Kantonsspital Liestal
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (ESTIMATE): June 28, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: excision; pilonidal sinus; limberg flap; primary wound closure
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: UKBB 234/05