Treatment of Pilonidal Sinus Disease Using Surgiflo as a... | NCT02638064

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

NCT02638064

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Dec 22, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Pilonidal Sinus Disorder

Interventions

Surgiflo injection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Dec 20, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgiflo injection	Experimental	Injection of surgiflo in the pilonidal sinus cavity after curettage of its content	Procedure: Surgiflo injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgiflo injection	Procedure	Curettage of sinus cavity then injection of surgiflo material	Surgiflo injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hosam Elbanna, M.D	private basis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hosam Elbanna		Al Mansurah	Dakahlia Governorate		Egypt

Intervention Browse Module

MeSH Terms

ID	Term
C000629581	Surgiflo

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided