- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664452
Current Status of Porcine Derived Products in Surgery
May 1, 2021 updated by: Elvan Onur Kirimker, Ankara University
Current Status of Utilization an Surgeons' View of Porcine Derived Medical Products: an International Survey
Porcine derived products are being used as biological grafts in mainly in orthopedic surgery, neurosurgery, cardiovascular surgery and general surgery.
It is well known that consuming pork or porcine products are prohibited in some religions or divisions of religions.
It may be a tender point for patients undergoing surgery in which porcine derived products are utilized.In this survey study we aimed to determine the level of awareness and perception of surgeons with an international anquette.
The study will also reveal the choices of surgeons about this issue both in elective and emergency procedures
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In the survey study an online anquette form will be sent through online surgery networks both professional and social media.
The questionnaire will not include questions defining the responders individually.
The questions are related to frequency of utilization of porcine derived products in surgery, surgeons' level of awareness about utilization of porcine products, surgeons' level of religiousity and surgeons' choices about porcine derived product utilization and consent of patients.
After collection of responses the data will be analyzed to discover current status of porcine derived surgical product utilization and surgeons' perception about the issue.
The anquette will be distributed worldwide to surgeons in different branches of surgery.
Literature seems to be lacking of that kind of study
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elvan Onur Kirimker
- Phone Number: 905327318075
- Email: kirimker@ankara.edu.tr
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Specialist of any branch of surgery excluding pathology and anesthesiology
Description
Inclusion Criteria:
- Being volunteer and responder of at least 80% of the study questionnaire
Exclusion Criteria:
- Responding less than 80% of the questionnaire
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgeons' awareness of utilization of porcine derived products in surgery
Time Frame: 2 month
|
Frequency of awareness and experience on porcine derived medical products
|
2 month
|
Surgeons' choice about utilization of porcine derived products in surgery
Time Frame: 2 month
|
Choices of surgeons on specific scenarios in the questionnaire
|
2 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship of porcine derived product utilization according to religious/phlosophical belief
Time Frame: 2 month
|
Choices of surgeons according to Religiousness Scale of Altemayer
|
2 month
|
Surgeons' choice about informing patients about porcine derived products
Time Frame: 2 month
|
What ar e the choices of surgeons about informing patients and their relatives in described scenarios in the questionnaire
|
2 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Anticipated)
May 5, 2021
Primary Completion (Anticipated)
August 20, 2021
Study Completion (Anticipated)
September 20, 2021
Study Registration Dates
First Submitted
December 6, 2020
First Submitted That Met QC Criteria
December 6, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 1, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PORCINE2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Only study protocol and results will be shared on the clinicaltrials.gov
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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