The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease

The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease ( Two Times of Recurrence or More): One Year Experience Study

Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus Treatment
• Intervention / Treatment: Procedure: keystone flap; Procedure: lay open

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqia
    • Zagazig, Sharqia, Egypt, 44519
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• re-recurrent pilonidal disease

Exclusion Criteria:

• patients with proved anal or perineal malignancy or autoimmune disease
• patient with pilonidal disease for the first time or for the first time of recurrence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: re- recurrent pilonidal sinus	Procedure: keystone flap; facio-cutaneous flap used to cover the defect after removal of the disease
Active Comparator: re-recurrent pilonidal sinus	Procedure: lay open; after removal of the disease, the wound is left open to heal by granulation tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time		operative time is measured in minutes from incision to wound dressing
bleeding amount	intra and post operative bleeding amount is measured in cc by volumetric method	amount of blood lost is measured from incision for 2 days post operative
healing time		healing time is measured for 3 months post-operatively
wound infection	wound infection evaluated by presence of pus from the first day post-operativel	wound infection is evaluated for 3 months post-operatively

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 14, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Cysts; Paranasal Sinus Diseases; Pilonidal Sinus
• Other Study ID Numbers: #881\8-Dec-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data will be available on demand by contacting the principle investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No