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.

Efficacy, Safety, and Cost-Effectiveness of Healthium Theruptor Versus 3M Tegaderm Versus Plain Gauze Dressing for Wound Dressings Used in Abdominal and Joint Surgeries: A Prospective, Multicentric, Randomized Study.

Background In the realm of surgical and postoperative care, the application of wound dressings is a standard practice to facilitate healing, minimize infection risks, and offer a protective barrier against pathogens for optimal recovery. For instance, Theruptor is an active advanced wound care product with patented microbicidal technology. In the present study, we conducted a randomized clinical trial to compare the clinical efficacy and safety of Healthium Theruptor, 3M Tegaderm, and plain gauze dressings in patients undergoing abdominal and joint surgeries. Methodology This was a multicenter, prospective, three-arm, randomized, double-blind study conducted between April and November 2022 at three different sites in India, viz., All India Institute of Medical Sciences, Jodhpur; Mahatma Gandhi Medical College and Research Institute, Puducherry; and SRM Institute of Science and Technology, Chennai. A total of 210 patients were randomized to receive either of the following three interventions: Theruptor, Tegaderm, and plain gauze dressing (n = 70 each) based on computer-generated randomization sequences using sequentially numbered, opaque, sealed envelopes. Demographic data and surgery details were obtained and recorded at baseline. Parameters such as rate of wound healing, incidence of surgical site infections (SSIs), adverse events, product performance, and pain score were assessed and compared during the weekly follow-up visits until 28 days. In addition, wound assessments using the Stony Brook Scar evaluation scale, Cardiff Wound Impact Questionnaire, and Modified Hollander Wound Evaluation Scale were conducted to provide additional insights on the efficacy of the dressings (days 3, 7, 14, and 28). Lastly, the cost of wound management was assessed at the end of the study. The statistical analysis of the data was performed using a one-way analysis of variance followed by a Bonferroni post-hoc test on GraphPad software. Results All three dressings were equally effective in healing the wound and reducing the incidence of SSIs. The median healing time was estimated to be seven days. Further, no significant difference was observed in wound dehiscence, wound pain, clinical wound parameters, cosmetic assessment, and quality of life among the three groups (p > 0.05) during the follow-up visits. However, the product performance of Theruptor and Tegaderm was significantly better than plain gauze dressing in terms of ease of application (82.87% and 84.13% vs. 71.7%), ease of removal (83.09% and 83.67% vs. 70.79%), comfort to wear (82.59% and 84.47% vs. 72.83%), exudate management (84.35% and 85.7% vs. 77.23%), mean wear time in hours (65.57 and 65.92 vs. 49 hours), and mobility of the patient (p < 0.05). Further, the total cost of wound management with Theruptor dressing was significantly lower than with Tegaderm dressing (₹1117.2 ± 269.86 vs. ₹1474 ± 455.63; p < 0.0001). Conclusions Although all three dressings were equally safe and clinically efficacious, Theruptor was more cost-effective with better product performance. Thus, Theruptor may be a considerate option in the postoperative wound management of abdominal and joint surgeries.