The SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding

Background: The SPOT GRADE (SG), a surface bleeding severity scale (SBSS), is a unique visual method for assessing bleeding severity based on quantitative determinations of blood flow. This study assessed the reliability of the SG scale in a clinical setting and collected initial data on the safety and efficacy of HEMOBLAST Bellows (HB), a hemostatic agent, in abdominal and orthopedic operations. Methods: Twenty-seven (27) subjects were enrolled across three (3) centers and received the investigational device. Bleeding severity and hemostasis were independently assessed by two (2) surgical investigators at baseline and at 3, 6, and 10 minutes after application of HB and compared for agreement. Results: The mean paired Kappa statistic for assignment of SG scores was 0.7754. The mean paired Kappa statistics for determining eligibility for participation in the trial based on bleeding severity and the mean paired Kappa statistics determining the presence of hemostasis were 0.9301 and 0.9301, respectively. The proportion of subjects achieving hemostasis within 3, 6, and 10 minutes of HB application were 50.0%, 79.2%, and 91.7%, respectively. There were no unanticipated adverse device effects (UADEs) and one possible serious adverse device effect (SADE), as determined by the Independent Data Monitoring Committee (IDMC). Conclusions: The reliability of the SG scale was validated in a clinical setting. Initial data on the safety and efficacy of HB in abdominal and orthopedic operations were collected and there were no concerns raised by the Investigators or the IDMC.