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

Abstract

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.

An Efficacy Comparison of Two Hemostatic Agents in a Porcine Liver Bleeding Model: Gelatin/Thrombin Flowable Matrix versus Collagen/Thrombin Powder

“…The porcine liver punch biopsy bleeding model was selected to reflect the indication for PCCT, which is limited to minimal to moderate bleeding corresponding to its approved indication [10,21]. These bleeding rates are also well within the indication for SmGM for treatment of oozing to spurting bleeding.…”

“…An animal experiment permit was issued by the municipal government of Vienna, and all experimental methods were consistent with the Guide for the Care and Use of Laboratory Animals of the US National Research Council [20]. The bleeding model used was aimed to reflect a bleeding intensity below 25.3 mL/min/cm 2 , which is consistent with PCCT product labeling [10,21]. This translates into <20 mL/min for the wound size of 0.785cm 2 used in this study.…”

“…At 7 and 11 minutes, the observed bleeding grade was lower for SmGM, although this was not significant (7 minutes Residual bleeding rates and bleeding grades where initial bleeding was <8.1 g/min. To evaluate whether there were differences in efficacy between lesions with mild or moderate initial bleeding rates [21], a further analysis was conducted, focusing on the results for lesions where the initial bleeding rate was lower than the average (8.1 g/min, Figure 3). This analysis included 15 lesions for SmGM and 19 for PCCT.…”

Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations

“…Preoperative inclusion criteria included: subject undergoing a nonemergent cardiothoracic operation and subject or an authorized legal representative provided prior written consent for trial participation. The intraoperative inclusion criteria included: subject did not have an active or suspected infection at the surgical site; subject in whom the Investigator was able to identify a target bleeding site (TBS) for which any applicable conventional means for hemostasis were ineffective or impractical; and subject had a TBS with minimal, mild, or moderate bleeding, assessed using a clinically validated bleeding severity scale …”

Variance estimation for the Kappa statistic in the presence of clustered data and heterogeneous observations

“…The ability to quickly stop a hemorrhage can mean the difference between a successful surgery and death: 27% of all deaths from a surveyed major US surgical center were related to hemorrhage or thrombosis . Yet, it is often difficult to precisely estimate blood loss, which is important in the comparison of existing agents and the validation of new ones.…”