Surgical Waste Remnants Protocol ZB02
This is a prospective, minimal-risk study collecting biological specimens that were previously surgical waste from standard elective procedures. During the course of surgery, some tissues are removed from the patient as a normal part of the procedure. Tissue that is ordinarily discarded following surgery will be donated to Zen-Bio to be included in a tissue procurement used for research purposes.
We do not wish to limit the number of participants in this ongoing study; however, we anticipate collecting samples from at least 100 participants during the initial course of this study. At UTSW and UTSW Ambulatory Services, about 125 subjects will be asked to participate in order to complete the study with 100 people. This study is taking place at approximately 5 medical facilities around the country. There will be a total of approximately 500 people participating in this research study throughout the United States. Enrollment of subjects is expected to continue for approximately one year.
The overall study duration for each subject will be approximately 10 days.
Each surgical remnant sample will be put into sterile specimen containers (provided by Zen-Bio). The sterile specimen container will be filled with Transport Media (also provided by Zen-Bio), placed in a biohazard zipper bag and shipped at ambient temperature or the optimum temperature that Zen-Bio is able to determine (bags and boxes provided by Zen-Bio) the same day as the surgery via Federal Express Priority Overnight (on the Zen-Bio account) or local courier to Zen-Bio. All surgical waste remnants will be handled according to Zen-Bio's Standard Operating Procedure for transport and handling of human tissues.
The following are included in the study:
- potential, healthy, adult participants (18-80 years old) are not excluded based on gender, race, or ethnicity;
- able to complete all study procedures and interventions;
- able to understand, read and sign an informed consent after the nature of the study has been fully explained;
- females of child bearing potential who are not planning to become pregnant during their participation in the study.