Effectiveness and safety of an absorbable modified polymer starch powder hemostat versus usual care in gynecology procedures: A prospective, multi-center, and randomized study

Abstract

Objective To evaluate the safety and effectiveness of an absorbable modified polymer starch powder hemostat (AMP-SPH) compared with standard care to control hemostasis when used in adult subjects during open or laparoscopic gynecological procedures for both benign and malignant diseases. Methods: Prospective, multi-center, randomized, and interventional phase IV study conducted on consecutive patients, aged >= 18 years, who underwent an open or laparoscopic gynecological procedure between November 2015 and July 2017 in a third-level Hospital. Study participants were randomly assigned (1:1) to receive either treatment with an AMP-SPH (AMP group) or usual standard care (SC group). The hemostatic treatment administered to the SC group was at the investigator's discretion. The primary effectiveness endpoint of the study was the achievement of hemostasis (yes/no) within 10 minutes. Results: Ninety patients, 44 (48.9%) in the AMP group and 46 (51.1%) in the SC group were included in the analysis. the AMP group, 97.7% (43/44) of patients achieved hemostasis as compared to the 93.5% (43/46) of subjects in the SC group (mean difference: 4.2%; 95%CI: -4.1% to 12.6%; p = .337). The time required to achieve hemostasis was lower in the AMP group (1.91 +/- 1.15 minutes) than in the SC group (2.28 +/- 2.09 minutes), although not significant (p = .309). A higher proportion of patients in the SC group (17.9%) was observed to require blood products compared to those in the AMP group (4.8%).A total of 29 adverse events (AEs) (24 non-serious and 5 serious AEs) were reported, 12 AEs in the AMP group and 17 in the SC group.Conclusions According to the results of this study, AMP-SPH was not inferior to standard care in the control of bleeding for patients undergoing gynecology procedures and the cessation of bleeding was trending to be faster with the use of AMP-SPH than with standard methods.Trial registration ClinicalTrials.gov NCT02835391.