Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept

Not Applicable

Completed

• Conditions: Pilonidal Sinus Disorder
• Interventions: Procedure: Surgiflo injection

• Registration Number: NCT02638064
• Lead Sponsor: Mansoura University

Brief Summary

Assessment of surgiflo injection for treating pilonidal sinus disease

Detailed Description

Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation includes recurrence, infection, complications and patient satisfaction over 2 years of follow up

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-03
• Study First Submitted: 2015-10-29
• Study Completion: 2015-11
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-20
• Last Update Submitted: 2015-12-20
• Study First Posted: 2015-12-22
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients included in the study had simple midline PS with single or multiple tracts and no lateral extensions. Recurrent cases of PS after previous surgery were also included in the study

Exclusion Criteria

We excluded from the study patients with severe scarring at the natal cleft due to previous surgery or infection and patients with signs of an acute abscess.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgiflo injection	Surgiflo injection	Injection of surgiflo in the pilonidal sinus cavity after curettage of its content

Primary Outcome Measures

Name	Time	Method
Recurrence of the condition	2 years	number of patients presenting with recurrent pilonidal sinus

Secondary Outcome Measures

Name	Time	Method
Complications of the procedure	2 years	number of patients presenting with complications after injection of surgiflo

Trial Locations

Locations (1)

Hosam Elbanna; 🇪🇬 Mansoura, Dakahlia, Egypt