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

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.

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.

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

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.

Clinical Trials on Ethics, Narrative

Clinical Trials on Questionnaire

3
Subscribe