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

December 20, 2015 updated by: Sameh Emile, Mansoura University
Assessment of surgiflo injection for treating pilonidal sinus disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Hosam Elbanna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgiflo injection
Injection of surgiflo in the pilonidal sinus cavity after curettage of its content
Procedure: Surgiflo injection
Curettage of sinus cavity then injection of surgiflo material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of the condition
Time Frame: 2 years
number of patients presenting with recurrent pilonidal sinus
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of the procedure
Time Frame: 2 years
number of patients presenting with complications after injection of surgiflo
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Hosam Elbanna, M.D, private basis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mansourau25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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