A new absorbable hemostatic gelatin matrix, Borayflo, has shown promising results in a recent clinical trial evaluating its efficacy and safety for intraoperative hemostasis. The study, a prospective, multicenter, single-blind, randomized, parallel-controlled trial, compared Borayflo to Surgiflo, a widely used hemostatic matrix.
The trial, conducted across four hospitals in China between August 2020 and July 2021, enrolled 354 participants undergoing surgeries where traditional hemostasis methods (compression, ligation) were insufficient. Participants were randomized 1:1 to receive either Borayflo or Surgiflo. The primary endpoint was the effective rate of hemostasis within 5 minutes of application.
Study Design and Key Outcomes
Eligible participants were aged 18-75 years with intraoperative bleeding from capillaries, veins, or small arteries. Exclusion criteria included active infections, coagulation disorders, recent use of platelet receptor antagonists, or allergy to porcine gelatin. The primary efficacy endpoint was the effective hemostasis rate at 5 minutes. Secondary endpoints included intraoperative hemostatic time, procedure time, changes in red blood cell counts and hemoglobin levels, intraoperative blood transfusion volume, and intraoperative bleeding volume.
The results indicated that Borayflo was non-inferior to Surgiflo in achieving hemostasis within 5 minutes. The study also assessed the safety and performance of Borayflo, monitoring vital signs, laboratory results, and adverse events before, within 48 hours after, and 6 weeks after the operation. Handling characteristics, such as ease of use and conformity to tissue, were also evaluated by surgeons.
Statistical Analysis and Ethical Considerations
The study employed modified intention-to-treat (ITT) and per-protocol populations for primary efficacy analysis. Statistical analysis was performed using the Cochran-Mantel-Haenszel test, stratified by study center. A non-inferiority margin of -10% was used, with a significance level of P < 0.05. Ethical approval was obtained from the ethics committees of all participating hospitals, and written informed consent was obtained from all participants.
The findings suggest that Borayflo Haemostatic matrix is a safe and effective alternative to Surgiflo Haemostatic matrix for achieving intraoperative hemostasis. This new option could provide surgeons with an additional tool for managing bleeding during surgical procedures.
