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

NCT ID: NCT02638064

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-11-30

Brief Summary

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Assessment of surgiflo injection for treating pilonidal sinus disease

Detailed Description

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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

Conditions

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Pilonidal Sinus Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgiflo injection

Injection of surgiflo in the pilonidal sinus cavity after curettage of its content

Group Type EXPERIMENTAL

Surgiflo injection

Intervention Type PROCEDURE

Curettage of sinus cavity then injection of surgiflo material

Interventions

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Surgiflo injection

Curettage of sinus cavity then injection of surgiflo material

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hosam Elbanna, M.D

Role: PRINCIPAL_INVESTIGATOR

private basis

Locations

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Hosam Elbanna

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansourau25

Identifier Type: -

Identifier Source: org_study_id