Safety and effectiveness of Merizelle oxidised regenerated cellulose in achieving haemostasis in surgical procedures: a surveillance study.

Abstract

Objective: Topical haemostatic materials applied to bleeding sites during surgery play an important role in intraoperative haemostasis. This study aimed to evaluate the clinical safety and efficacy of Merizelle oxidised regenerated cellulose (ORC) (Meril Life Sciences Pvt. Ltd., India) in achieving haemostasis across various surgical procedures.

Method: This was a prospective, multicentre, single-arm, observational, post-marketing surveillance study. The primary endpoint was the proportion of patients achieving haemostasis within 10 minutes of application of ORC at target bleeding sites. The secondary endpoints were the absence of proven infection and the absence of bleeding-related adverse events (AEs) until six months after surgery. Patients were followed up at discharge, two weeks, one month, three months and six months after the index procedure.

Results: In all, 189 patients were screened and enrolled, and 188 patients completed the study. The mean±standard deviation (SD) age of patients was 43.00±12.79 years and 59.79% were female. Neurological surgeries, nephrectomy and lower segment caesarean section were the most common surgeries performed. The mean±SD length of hospital stay was 6.28±4.08 days and the mean±SD coagulation time was 2.57±1.12 minutes. Haemostasis was achieved in all patients with the use of Merizelle ORC, with 94.68% of patients achieving it within 10 minutes. Almost 80% of patients had mild-to-moderate bleeding. There were no cases of bleeding-related AEs, proven infection or death at the end of all follow-ups.

Conclusion: The ORC demonstrated excellent safety with no occurrence of bleeding-related AEs, proven infections or postoperative death.