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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638064
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Study Description
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Brief Summary:
Assessment of surgiflo injection for treating pilonidal sinus disease

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Disorder Procedure: Surgiflo injection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : November 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence of the condition [ Time Frame: 2 years ]
    number of patients presenting with recurrent pilonidal sinus


Secondary Outcome Measures :
  1. Complications of the procedure [ Time Frame: 2 years ]
    number of patients presenting with complications after injection of surgiflo


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638064


Locations
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Egypt
Hosam Elbanna
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Hosam Elbanna, M.D private basis
More Information
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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02638064    
Other Study ID Numbers: mansourau25
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Pilonidal Sinus
Paranasal Sinus Diseases
Cysts
Neoplasms
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Surgiflo
Hemostatics
Coagulants