A Randomized Study Evaluating Clinical Efficacy and Safety of Trusteel® and Ethisteel® Surgical Steel Sutures for Sternal Closure in Subjects Undergoing Surgical Procedures by Sternotomy.

INTRODUCTION

Sternal dehiscence and other post-sternotomy complications, viz. superficial and deep sternal wound infection, mediastinitis, and sternal instability increase the risk of mortality. Sternotomy closure with steel sutures results in a low complication rate. Therefore, this study compared the clinical equivalence of Trusteel® (Healthium Medtech Limited, Bengaluru, India) and Ethisteel® (Ethicon, Johnson & Johnson, Cincinnati, USA) surgical steel sutures for sternal closure following median sternotomy.

METHODS

The primary endpoint of this prospective, single-blind, multicentric, two-arm, randomized (1:1) study (April 2021-April 2023) was a comparison of the proportion of subjects having sternal dehiscence within 26 weeks of the median sternotomy closure between Trusteel® (n=33) and Ethisteel® (n=34) groups. Secondary endpoints comprised an assessment of intraoperative suture handling, the incidence of mortality and other complications of sternal closure, operative time, intensive care unit (ICU)/hospital stay, return to normal day-to-day activities and work, subject satisfaction and general well-being, and adverse events in both groups. A statistically significant result between the groups was considered at p<0.05.

RESULTS

No incidence of sternal dehiscence or other post-operative complications were recorded. A significant difference (p<0.05) in the stretch capacity of Trusteel® and Ethisteel® sutures was noted; otherwise, ease of passage, knot holding, knot security, knot tie-down smoothness, and memory of both sutures had comparable ratings. Operative time, ICU/hospital stay, and return to normal day-to-day activities and work were comparable between the groups. Improvement in post-operative functional abilities, quality of life, and health status was evident in both groups and was comparable.

CONCLUSION

Trusteel® surgical steel suture is clinically equivalent to Ethisteel® surgical steel suture and is safe and effective for sternal closure following median sternotomy.