Available Clinical Trials 

A Randomized Study Evaluating Patients Discharged with Indwelling Chest Tube and Valve

PI: K. Robert Shen, MD, Mayo Clinic Rochester

Phase II

Randomized Methodology

Overall Study Duration: 5 years

Subject Participation Duration: 30 Days

Primary Objective: To assess the efficacy of antibiotics and closer monitoring on decreasing empyema in patients discharging with a chest tube and valve in place as measured by documented empyema following discharge.

Secondary Objective: To assess the efficacy of antibiotics and closer monitoring on decreasing hospital readmissions while the chest tube and valve are in place as measured by readmission to the hospital following hospital discharge after the initial surgical intervention.

Number of Subjects: 560

Diagnosis and Main Inclusion Criteria: Discharge from the hospital with an indwelling chest tube and valve in place

Study Treatment: Oral antibiotics and close monitoring (defined as twice weekly telephone calls by a member of the care team)

Reference Treatment: Standard of Care (defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped)

Statistical Methodology: Comparison of the rate of empyema and readmission in the two arms of the study

Protocal

Consent

Schema

Contact for more Information

GTSC Executive Office:
1935 County Road B2 W, Ste 165 | Roseville, MN 55113
952-646-2048    info@gtsc.org
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