Thoracostomy Tube Irrigation: a Multi-Center Trial

Active, not recruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

December 30, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Thoracic Trauma
Interventions
PROCEDURE

thoracic irrigation

We will start this study using 20% as the approximate national intervention rate, based on current literature, with the goal of detecting a 50% reduction in the experimental arm (i.e. 10% secondary intervention rate after thoracic irrigation). Therefore, we will plan to enroll 108 patients in the irrigation cohort and 324 patients in the control cohort. An interim analysis will be conducted once 54 patients have been enrolled in the irrigation cohort. The secondary intervention rate in the irrigation cohort and the standard cohort will be determined, and any adjustments to sample size will be made at that time.

Trial Locations (1)

75203

Clinical Research Institute Methodist Health System, Dallas

All Listed Sponsors
lead

Methodist Health System

OTHER