Efficacy and safety of regenerated cellulose topical gauze haemostats in managing secondary haemostasis: a randomised control trial.

OBJECTIVE: To compare the efficacy and safety of HemoStyp (United Health Products, US), a neutralised oxidised regenerated cellulose (NORC) and Surgicel (Johnson & Johnson, US), an oxidised regenerated cellulose (ORC), in the management of bleeding of surgical wounds during abdominal, thoracic and vascular surgeries.

METHOD: This study was a prospective, non-inferiority, multicentre, randomised, open-label trial. Surgical procedures were performed according to expected standard of care and in compliance with all relevant laws and institutional guidelines. Patients who developed Lewis Bleeding Scale grade 1 and grade 2 bleeds not controlled through conventional techniques were randomised to either the NORC or ORC treatment arms. Bleeding was measured every 30 seconds after treatment, ending at five minutes after haemostasis was achieved or at 10 minutes if haemostasis was not achieved.

RESULTS: A total of 236 patients were included in the study. There was a total of seven adverse events in the study, none of which had causality related to either the NORC or ORC. For all surgical procedures, haemostasis was achieved more quickly with the NORC than the ORC (p<0.0001). In addition, haemostasis for all patients was achieved in under two minutes for the NORC compared with 81% of patients in the ORC groups. For Lewis Bleeding Scale grade 1 bleeds, the median time to control bleeding was 24 seconds in the NORC group and 51 seconds for the ORC group. For grade 2 bleeds, time to control bleeding was 76 seconds and 116 seconds, respectively.

CONCLUSION: For patients in this study, haemostasis was achieved more quickly in the NORC treatment group compared with the ORC group, in patients with Lewis grade 1 or 2 bleeds caused by surgical wounds generated during abdominal, thoracic and vascular surgeries.