Evaluating the Clinical Equivalence of Truwax® and Ethicon® Bone Waxes for Sternal Wound Hemostasis: A Prospective Randomized Study

TL;DR

This study compared two bone waxes, Truwax and Ethicon, for their effectiveness in preventing sternal complications after chest surgery.

Contribution

The study provides clinical evidence of the equivalence of Truwax and Ethicon bone wax for sternal wound hemostasis.

Findings

No sternal dehiscence or postoperative complications were observed in either group.

Truwax and Ethicon showed comparable performance in hemostasis time, pain, and patient satisfaction.

Both bone waxes resulted in similar ICU/hospital stays and return to normal activities.

Abstract

Background: Incidence of sternal dehiscence, wound infection, and mortality are prevalent following sternotomy. Bone wax is widely used over the sternal edges for augmenting hemostasis. This study evaluated the clinical equivalence of Truwax® (Healthium Medtech Limited, Bengaluru, India) with Ethicon® (Johnson & Johnson, New Brunswick, New Jersey, United States) bone wax for sternal wound hemostasis in subjects undergoing surgical procedures by sternotomy.

Methods: The primary endpoint of this prospective (May 2022-April 2023), parallel-group, two-arm, randomized, single-blind, multicenter study was to evaluate the proportion of subjects having sternal dehiscence within 26 weeks of median sternotomy closure. Secondary endpoints assessed the average time to hemostasis on sternum sides, bone wax properties, number of dressing changes, sternal bone instability (clinically/chest radiography), pain, perioperative/postoperative complications, blood and blood products used, duration of intensive care unit (ICU)/hospital stay, reoperations, time taken to return back to work and normal day-to-day activities, subject satisfaction and quality of life (QoL), and adverse events. A probability of <0.05 was considered significant.

Results: No incidence of sternal dehiscence or postoperative complications was witnessed. Time to hemostasis, bone wax properties, number of dressing changes, sternal stability, pain, blood and blood products used, duration of ICU/hospital stay, reoperations, time taken to return back to normal day-to-day activities and to work, and subject satisfaction and QoL were comparable between Truwax® and Ethicon® bone wax groups.

Conclusion: Truwax® and Ethicon® bone waxes are safe and effective and provide sternal wound hemostasis in people undergoing sternotomy.

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