NCT02638064

Brief Summary

Assessment of surgiflo injection for treating pilonidal sinus disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

October 29, 2015

Last Update Submit

December 20, 2015

Conditions

Pilonidal Sinus Disorder

Outcome Measures

Primary Outcomes (1)

  • Recurrence of the condition

    number of patients presenting with recurrent pilonidal sinus

    2 years

Secondary Outcomes (1)

  • Complications of the procedure

    2 years

Study Arms (1)

Surgiflo injection

EXPERIMENTAL

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

Procedure: Surgiflo injection

Interventions

Surgiflo injectionPROCEDURE

Curettage of sinus cavity then injection of surgiflo material

Surgiflo injection

Eligibility Criteria

Age14 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hosam Elbanna

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Interventions

Surgiflo

Study Officials

  • Hosam Elbanna, M.D

    private basis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

October 29, 2015

First Posted

December 22, 2015

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

November 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

EG(1)