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Related Experiment Video

Updated: Dec 14, 2025

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

Daniel J Del Gaizo1, William D Spotnitz2,3, Rachel W Hoffman3,4

  • 1Department of Orthopedics, University of North Carolina, Chapel Hill, NC, USA.

Clinical and Applied Thrombosis/Hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
|July 25, 2020
PubMed
Summary

The SPOT GRADE (SG) scale reliably assesses surgical bleeding. HEMOBLAST Bellows (HB) demonstrated promising safety and efficacy in achieving hemostasis during abdominal and orthopedic surgeries.

Keywords:
HEMOBLAST BellowsSPOT GRADESurface Bleeding Severity Scaletarget bleeding site

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Area of Science:

  • Surgical innovation
  • Hemostasis assessment
  • Medical device evaluation

Background:

  • Assessing surgical bleeding severity is critical for patient outcomes.
  • Existing methods for bleeding assessment lack standardization.
  • The SPOT GRADE (SG) scale offers a visual, quantitative approach to bleeding assessment.

Purpose of the Study:

  • To validate the reliability of the SG scale in a clinical setting.
  • To collect preliminary data on the safety and efficacy of HEMOBLAST Bellows (HB) as a hemostatic agent.
  • To evaluate HB's performance in abdominal and orthopedic procedures.

Main Methods:

  • A prospective study involving 27 patients across 3 centers.
  • Independent assessment of bleeding severity and hemostasis by two surgical investigators using the SG scale.
  • Evaluation at baseline and at 3, 6, and 10 minutes post-application of HB.
  • Inter-rater reliability assessed using the kappa statistic.

Main Results:

  • High inter-rater reliability for SG scale assignments (κ = 0.7754) and hemostasis determination (κ = 0.9301).
  • HEMOBLAST Bellows achieved hemostasis in 50.0% of patients by 3 minutes, 79.2% by 6 minutes, and 91.7% by 10 minutes.
  • No unanticipated adverse device effects were reported; one possible serious adverse device effect was noted by the IDMC.

Conclusions:

  • The SG scale is a reliable tool for assessing bleeding severity in clinical practice.
  • HEMOBLAST Bellows shows potential as a safe and effective hemostatic agent for surgical applications.
  • Further investigation into HB's efficacy and safety profile is warranted.