At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure
In Brief
A clinical study evaluating Sternalock Rigid Fixation for Pain. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal closure system with equivocal results; however, the outcomes of these two methods have never been investigated in a randomized study. Thus, the investigators are conducting this study to compare two different methods of closure if one method demonstrates any recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or stainless steel wire closure. Recover benefit will be measured by postoperative intubation time, length of intensive care unit stay, and overall postoperative length of stay
Study Details
Timeline
Interventions
Patients will have their sternum closed by rigid fixation using Sternalock plates.