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

Primary Purpose

Pilonidal Sinus Disorder

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Surgiflo injection

About this trial

This is an interventional treatment trial for Pilonidal Sinus Disorder

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hosam Elbanna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgiflo injection

Arm Description

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

Outcomes

Primary Outcome Measures

Recurrence of the condition

number of patients presenting with recurrent pilonidal sinus

Secondary Outcome Measures

Complications of the procedure

number of patients presenting with complications after injection of surgiflo

Full Information

NCT ID

NCT02638064

First Posted

October 29, 2015

Last Updated

December 20, 2015

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02638064

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pilonidal Sinus Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgiflo injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgiflo injection

Intervention Description

Curettage of sinus cavity then injection of surgiflo material

Primary Outcome Measure Information:

Title

Recurrence of the condition

Description

number of patients presenting with recurrent pilonidal sinus

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Complications of the procedure

Description

number of patients presenting with complications after injection of surgiflo

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hosam Elbanna, M.D

Organizational Affiliation

private basis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hosam Elbanna

City

Mansoura

State/Province

Dakahlia

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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