Incidence of COVID-19 Test Conversion in Post-surgical Patients

Who is this study for? Adult patients that are undergoing an elective surgical procedure
Status: Completed
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The current Sars-CoV-2 (COVID-19) pandemic has created major changes in how physicians perform routine healthcare for our patients, including elective and non-elective surgical procedures. Beginning on March 16th, 2020 Northwell Health postponed all elective surgeries. As the incidence of COVID-19 cases begins to decrease and hospital volume improves we need to ensure the safety of our patients planning surgical procedures. However, at this time there is a scarcity of data regarding the COVID-19 test conversion rate in surgical patients. Our goal is to determine the COVID-19 test conversion rate in these patients to better guide strategies for restarting surgical care in a large-scale pandemic. Patients will be routinely tested with serology and PCR for COVID-19 24-48 hours prior to their scheduled surgery. Those who provide informed consent will be re-tested 12-16 days after discharge from the hospital to determine any potential nosocomial infection rate. Patients will also answer a few questions during their retest to allow the study team to gauge exposure risk postoperatively after leaving the hospital.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients of any ethnic background undergoing an elective surgical procedure with a minimum of 24-hour hospital admission.

• Age ≥18.

• Written Voluntary Informed Consent.

Locations
United States
New York
North Shore University Hospital
Manhasset
Long Island Jewish Medical Center
New Hyde Park
Time Frame
Start Date: 2020-05-13
Completion Date: 2020-10-04
Participants
Target number of participants: 111
Treatments
Experimental: Study Group
Patients will be recruited as an outpatient prior to their surgical procedure or during their hospital admission. If they consent, they will provide signed informed consent and will receive testing with serology and PCR for COVID-19 infection at pre-surgical testing 24-48 hours prior to their scheduled procedure. If they consent while inpatient postoperatively, signed informed consent will be procured after they have completed their pre-operative COVID-19 testing. PCR for COVID entails obtaining a nasopharyngeal swab to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital.
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov