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

NCT06741449 | Completed

• 1 other identifier: #881\8-Dec-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pilonidal Sinus Treatment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

re- recurrent pilonidal sinus

ACTIVE COMPARATOR

Procedure: keystone flap

re-recurrent pilonidal sinus

ACTIVE COMPARATOR

Procedure: lay open

Interventions

keystone flap PROCEDURE

facio-cutaneous flap used to cover the defect after removal of the disease

re- recurrent pilonidal sinus

lay open PROCEDURE

after removal of the disease, the wound is left open to heal by granulation tissue

re-recurrent pilonidal sinus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• re-recurrent pilonidal disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery, faculty of medicine, Zagazig University

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 19, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-12

Locations

EG (1)