Experiences With Automated Surgical Drainage in Cardiac Surgery

Completed

Conditions studied: Hemorrhage

In brief

The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over the current standard of care system for the removal of surgical fluids following cardiac surgery. Observations, experiences, and outcomes in a single hospital setting will be collected for the Thoraguard Surgical Drainage System.

Key facts

Study ID

NCT03860363

Run by

Centese, Inc.

People needed

28

Starts

2019-02-22

Expected to finish

2020-05-30

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (age ≥ 18)
• Patient undergoing non-emergent cardiac surgery
• Anticipated requirement for mediastinal chest tube drainage

You may not qualify if…

• Emergency surgery
• Re-do surgery
• Prior cardiac surgery
• Congenital cardiac disease or deformation
• Transplant surgery
• Ventricular Assist Device Surgery
• Suspected pulmonary air leak
• Atrial fibrillation
• In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
• Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
• Pregnancy

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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