RESUMEN
BACKGROUND: The comparison of triclosan-coated sutures (TCS) was made with conventional nonantimicrobial-coated sutures (NCS) to reduce surgical site infection (SSI). This study demonstrates the efficacy and economic outcome of TCS versus NCS for SSIs in mastectomy in India. METHODS: In this retrospective analysis, 100 patients were included for both conditions-TCS and NCS-from a private and public hospital in India. A systematic literature search of available evidence for both SSI incidences and TCS efficacy data in India were gathered. We collected cost data from a private and public hospital, respectively, for mastectomy in India. The cost-effectiveness of TCS in comparison with the conventional NCS was calculated using a decision-tree deterministic model. We performed a one-way sensitivity analysis to compare TCS with NCS. RESULTS: Cost savings with the use of TCS increased with an increase in SSI incidence and an increase in efficacy for mastectomies in both public and private hospitals. We found a base cost saving of Indian rupees (INR) 27,299 at a private hospital and INR 2,958 at a public hospital for mastectomies. The incremental cost of TCS suture was 0.01% in a private hospital whereas 0.17% in a public hospital. CONCLUSION: The use of TCS resulted in reduced SSI incidence and cost savings for mastectomy in India.
RESUMEN
Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use and it is now important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of 'follow-on' nanomedicine products, 'nanosimilars'. Moreover, drug regulators need to ensure that 'next'-generation nanomedicines enter clinical development and consequently the market in a safe and timely way for the benefit of public health. Here we review recent European Medicines Agency activities that relate to the effective development and evaluation of nanomedicine products while keeping patient and consumer safety at the forefront.
