American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Clinical Issues and Guidance

The Latest in Promising Therapeutics: Remdesivir, Convalescent Plasma, and Antibody Testing

The Food and Drug Administration (FDA) has issued emergency use authorizations for remdesivir to treat COVID-19 and a new antibody test from Roche, as well as new guidance for investigational new drug applications for convalescent plasma in severe COVID-19.

The FDA issued an emergency use authorization (EUA) for the use of remdesivir in treatment of COVID-19, effective May 1, which enables remdesivir to be used outside a clinical trial more easily. Last week, the National Institute of Allergy and Infectious Diseases (NIAID) reported findings from a preliminary analysis of remdesivir, which indicated that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received a placebo.

The FDA also issued new guidance for investigational new drug (IND) applications for the use of convalescent plasma in patients with severe COVID-19 disease. This guidance includes pathways for clinical trials and single patient emergency INDs. For single patient emergency INDs, physicians must determine that the probable risks of administering this treatment to a patient is not greater than the probable risk from the disease. These applications may be made 24 hours/day and seven days/week and can be accessed here.

In addition, the FDA issued an EUA May 3 for the use of a COVID-19 antibody test from Roche. This test confirms exposure to the SARS-CoV-2 virus with detection of formation of antibodies to the virus. When done 14 days after a positive confirmation of a SARS-CoV-2 test, this antibody test has a specificity of 99.8 percent and a sensitivity of 100 percent, meaning false negatives and false positives are rare. The data at this time are too limited to determine if this test is effective in measuring immunity to reinfection or how long the antibodies persist after exposure.

New Guidelines for Thoracic Procedures from the American Association for the Surgery of Trauma

New American Association for the Surgery of Trauma guidelines for thoracic procedures, including chest tube placement and removal, recommend the development of a local protocol that includes a risk-benefit assessment before procedures are performed, as well as careful protection of health care professionals before, during, and after the procedures.

Assembling a thoracic procedures team and portable equipment bags for tube thoracostomy is recommended. A clear thoracic procedure algorithm and step-by-step descriptions of procedures are provided. One recommendation includes adding bleach to the water seal chamber in the chest tube drainage apparatus. Whereas most commercially available thoracotomy systems contain a 45–60mL water seal volume, 1 mL of bleach may be added to 50mL of water. The paper encourages clinicians to be cognizant of local protocols to ensure optimal integration with national recommendations for these procedures.

Stepping Outside Your Typical Scope of Work? Resources from the University of Wisconsin May Help

The University of Wisconsin-Madison (UW) has developed guidance for surgeons and other health care professionals who do not routinely provide trauma/burn or intensivist care, as many providers have been asked to step out of their typical scope of work because of COVID-19. UW is making the resources widely available via the ACS.

These resources include:

  • Trauma and Burn Primer: Reviews evaluation and management of common trauma and burn diagnoses for the general surgeon who does not normally care for trauma/burn patients
  • UW Critical Care Team Visit Work Flow: A checklist to guide critical care team rounds
  • “Primer” on Caring for Critical Care Patients: Covers common topics and diagnoses within critical care, from ventilator modes to sepsis and beyond
    • UW COVID-19 Critical Care Primer: Provides a high-yield guide to the diagnosis, treatment, and outcomes of critically ill COVID-19 patients
    • UW General Critical Care Primer: Offers a systems-based rounding format with a quick review of core topics and management decisions to be addressed during rounds
    • “Primers” for Specific Patient Populations: Designed to be used as a supplement to the UW General Critical Care Primer
      • UW Medical Critical Care Primer: Highlights specific diagnoses commonly seen in the medical intensive care unit (ICU) (“trauma and life support center”)
      • UW Surgical Critical Care Primer: Highlights specific diagnoses commonly seen in the surgical ICU, including some protocol-based outlines of care for common injuries and surgical procedures
  • UW Must Call ICU List should be reviewed by lower “tiered” providers as a reminder for when to contact the supervising ICU faculty
  • Thinking Simple about Ventilator Management: Four-part voice-annotated PowerPoint presentation reviewing the basics of ventilators

For more information, contact Angela “Angie” Ingraham, MD, MS, FACS, Assistant Professor of Surgery, University of Wisconsin-Trauma and Acute Care Surgery at 608-262-6246 or ingraham@surgery.wisc.edu. Dr. Ingraham and an interdisciplinary team at UW developed these materials.

ACS Registry Options and Guiding Principles for COVID-19 Outcomes Tracking

Significant uncertainties exist regarding reopening shuttered surgical services and assuring that surgical structures and processes have been restored post-pandemic. The ACS advises that reopening surgical services in a post-pandemic period involves outcomes tracking at the institutional level for all surgical services. The ACS has developed a low-burden/low-cost registry as well as included COVID-19 variables in our high-fidelity registries, including the ACS National Surgical Quality Improvement Program (NSQIP®) registry, to accomplish this goal.

U.S. Department of Health and Human Services Provides Information to Guide States on Reopening

As governors move forward on decisions to reopen some parts of their states, the Administration is issuing guidance for the range of situations that are part of reopening. An excerpt of the latest guidance can be found here.

Testing updates

  • Contact tracing training guidance: The Centers for Disease Control and Prevention (CDC) released a training module on contact tracing. This web page contains a sample training plan that may be helpful for state and local public health jurisdictions to consider when designing their own training programs for COVID-19 contact tracers. Suggested training modalities/formats are provided, as well as information about existing training initiatives and resources. This document may be updated as new resources become available.
  • Information on evaluation and testing patients: The CDC updated its guidance on evaluating and testing persons for COVID-19. The updates include recommendations for testing, specimen collection, reporting patients and reporting positive test results, and specification of testing priorities.
  • CDC resources for testing: The CDC released a new fact sheet on federal resources for COVID-19 contact tracing staff, which describes several ways health departments can access additional staffing for COVID-19 contact tracing, including through State Service Commissions and AmeriCorps Programs, the CDC, and the Federal Emergency Management Agency (FEMA).

Treatment updates

  • Symptom-based strategy for discontinuing isolation: The CDC released updated recommendations for discontinuing isolation. In the context of community transmission where continued testing is impractical, available evidence at this time indicates that an interim strategy based on time-since-illness-onset and time-since-recovery can be implemented to establish the end of isolation.
  • Updated information on discontinuing isolation: The CDC also updated its discontinuation of isolation for persons with COVID-19 who are receiving care outside of health care facilities. Updates include extending the home isolation period based on evidence suggesting a longer duration of viral shedding and will be revised as additional evidence becomes available. The clinical care guidance for health professionals and information on what to do if you are sick also were updated to reflect this change.

Information for specific populations

  • Tips for health care systems to operate effectively: The CDC released 10 ways health care systems can operate effectively during the COVID-19 pandemic. This document provides practical approaches that can be used to protect health care personnel (HCP), patients, and communities. The tips include information on work safety and support, patient service delivery, data streams for situational awareness, facility practices, and communications.
  • Information for pediatric health care providers: The CDC updated its resources for pediatric health care providers on what to do when managing pediatric patients with suspected or confirmed COVID-19. The web page has information on maintaining childhood immunizations during the pandemic, the burden of COVID-19 among children, the clinical presentation of COVID-19 in children, treatment and prevention for children, and additional resources.
  • Information for environmental health practitioners: The CDC posted information for specific environmental health practitioners, including congregate facilities and shelters such as general population disaster shelters, correctional and detention facilities, retirement communities, child care centers that remain open, cooling centers, and more. This web page provides information for environmental health practitioners from the CDC and other trusted sources.