- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02638064
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
-
-
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
|
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
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.
Clinical Trials on Pilonidal Sinus Disorder
-
Northwell HealthPediatric Surgical Research CollaborativeActive, not recruitingPilonidal Disease | Pilonidal Sinus Without Abscess | Pilonidal Cyst/Fistula | Pilonidal Cyst Without Abscess | Pilonidal Cyst and Sinus Without Abscess | Pilonidal Abscess | Pilonidal Sinus With Abscess | Pilonidal Dimple With Abscess | Pilonidal Fistula With Abscess | Pilonidal Sinus Infected | Pilonidal... and other conditionsUnited States
-
dr. IJM Han-GeurtsUMC Utrecht; Albert Schweitzer Hospital; Flevoziekenhuis; Ziekenhuis Amstelland; Proctos... and other collaboratorsNot yet recruitingPilonidal Sinus | Pilonidal Disease | Pilonidal Sinus of Natal Cleft | Pilonidal Sinus Without Abscess | Pilonidal Disease of Natal Cleft
-
London North West Healthcare NHS TrustUnknownPilonidal Disease | Pilonidal Abscess | Pilonidal Sinus With Abscess | Pilonidal Sinus Infected
-
Umraniye Education and Research HospitalRecruitingPilonidal Sinus of Natal Cleft | Pilonidal Sinus Without AbscessTurkey
-
Siverek Devlet HastanesiHarran UniversityCompletedPILONIDAL SINUS
-
Assiut UniversityNot yet recruitingPilonidal Sinus Infected
-
Fondation Hôpital Saint-JosephActive, not recruitingInfected Pilonidal SinusFrance
-
Gazi UniversityAnkara Oncology Research and Training Hospital; Ankara Diskapi Yildirim Beyazit...Completed
-
Groupe Hospitalier Paris Saint JosephCompletedInfected Pilonidal SinusFrance
-
Federico II UniversityCompletedChronic Sacrococcygeal Pilonidal SinusItaly
Clinical Trials on Surgiflo injection
-
CryoLife EuropaCompletedCancer | Endometriosis | Uterine Fibroids | Menorrhagia | Ovarian CystSpain
-
Rambam Health Care CampusCompleted
-
Centre Hospitalier Universitaire de BesanconCompletedOtorhinolaryngologic Diseases
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Malignant TumorsChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Dalia Salah SaifUnknownRA - Rheumatoid ArthritisEgypt