RESUMO
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.
RESUMO
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 (â¹1117.2 ± 269.86 vs. â¹1474 ± 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.
