Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system.

Area of Science:

• Cardiothoracic Surgery
• Biomedical Engineering
• Medical Devices

Background:

• Traditional steel wire cerclage for sternal closure after open heart surgery can lead to complications like pain, sternal dehiscence, and non-union.
• These complications increase hospital stays, costs, morbidity, and patient dissatisfaction.
• The Figure 8 FlatWire Sternal Closure System offers a novel, potentially superior alternative for primary sternal repair.

Purpose of the Study:

• To evaluate the initial clinical experience of the Figure 8 FlatWire Sternal Closure System in a prospective, randomized, single-blinded pilot study.
• To compare the efficacy and safety of FlatWire versus traditional steel wire cerclage for sternal closure after open heart surgery.

Main Methods:

• A prospective, randomized, single-blinded pilot study involving 63 patients undergoing elective complete sternotomies.
• Patients were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage.
• Data collected included patient demographics, surgical parameters, length of hospital stay, cost, and pain scores at multiple time points.

Main Results:

• Patients receiving the Figure 8 FlatWire reported significantly decreased pain at hospital discharge (p<0.0066).
• A trend towards reduced length of hospital stay (6.8 vs. 7.8 days) and lower mean cost ($87,820.98 vs. $91,930.29) was observed, though not statistically significant.
• Off-pump to surgical stop time was significantly increased in the FlatWire group (p=0.00025).

Conclusions:

• The Figure 8 FlatWire Sternal Closure System demonstrates excellent stability and significantly reduces postoperative pain at discharge.
• While trends suggest potential benefits in reduced length of stay and cost, further research is needed.
• Larger clinical studies are warranted to validate long-term outcomes and confirm the advantages of the FlatWire system.