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Clinical Researchers 2018-07-09T19:09:22+00:00

Clinical Researchers

Augustine Surgical Inc. (ASI) is actively looking for clinical researchers who are interested in studying the relative safety of forced-air warming (e.g., Mistral Air®, Bair Hugger®) vs. air-free
conductive fabric warming (HotDog®). We want to carry this research beyond hip and knee implant infections to infections of all implanted foreign materials.

Background

At this date, all credible published studies indicate that the waste heat from FAW is causing contamination of the sterile surgical field. Studies also link this airborne contamination to hip and knee implant infections. Nevertheless, 3M continues to sell Bair Hugger and Stryker continues to sell Mistral Air for use in all surgeries, including orthopedics. Clinicians rely on the manufacturers’ assurances of safety as they continue using FAW during implant surgery.

It is well known that many pathogenic organisms can effectively form biofilm in the presence of implanted foreign materials, in contrast to soft tissue, where biofilm is not formed. This explains why a single airborne bacterium can cause a hip or knee implant infection, whereas >1 million bacteria are required to cause a soft tissue infection. We believe that all implanted materials have the same increased infection risk as orthopedic hip and knee implants, and this research effort is designed to investigate the hypothesis that the sterile field contamination from FAW waste heat is causing many different implant infections.

Clinical Research Diagram Clinical Research Diagram

Proposed Research Effort:


  1. Study retrospective outcomes research to further test the hypothesis that waste heat from FAW increases the risk of periprosthetic joint infections (PJI) following joint replacement surgery.

  1. Study retrospective outcomes research to test the hypothesis that waste heat from FAW increases the risk of implant infections following surgeries involving all implanted materials. Other implant infection categories to be investigated include:
    • Orthopedic fracture plate infections
    • Spinal hardware infections
    • Hernia mesh infections
    • Vaginal mesh infections
    • Vascular graft infections

  1. Further investigate the mechanisms of sterile field contamination by waste FAW heat.

Purpose of this Research Effort:

  • To improve surgical patient safety.
  • To gain greater scientific understanding of airborne contamination of the sterile surgical field by waste heat in general and waste FAW heat specifically.
  • To further investigate the link between waste FAW heat and orthopedic implant infections.
  • To determine if there is a link between waste FAW heat and infections of other implanted materials.
  • To increase awareness for both clinicians and patients of the risks of waste FAW heat in implant surgery.
  • To provide scientific support for the estimated 500,000+ patients who have suffered from catastrophic infections following various implant surgeries and who may want to seek compensation from the FAW manufacturers. It is my belief that any infection involving implanted foreign materials more likely than not was caused by airborne contamination mobilized by the waste heat from FAW. In my opinion, the publicly available record from current litigation indicates that 3M management is well aware of these risks yet recklessly continues to sell their FAW products for use during implant surgery and continues to give false assurances of safety to clinicians. Presumably the other FAW companies are equally aware. I believe that the FAW companies should be held financially responsible for these injuries.

Summary

As long as FAW companies continue to sell FAW for use during implant surgeries, ASI is committed to encouraging and assisting with studies of sterile field contamination by waste FAW heat and the linkage of that contamination to all types of implant infections. The proposed outcome studies are very easy to do: you compare your implant infection rate during that last year of FAW use to your infection rate during your first year of HotDog use, write it up and publish it in one of the numerous peer-reviewed medical journals looking for content. We can help you if necessary.

If you are a current HotDog customer, you may already have these data. However, there is no need to be a current HotDog user to participate in this research; we will supply the needed equipment free of charge (conditions apply). There will most likely never be a randomized prospective trial (RCT) investigating these questions. Considering the strength of the currently available evidence linking FAW to implant infections, it is arguably unethical for an IRB to allow such a study. If an IRB did allow an RCT to proceed, adequate patient consent would be impossible to obtain. Therefore, retrospective outcomes research is most likely the best quality data that will ever be available for clinical decisions on this subject.

Please consider participating in this clinically important research effort.

If you are interested in participating in this research or simply want to discuss the subject further, contact me at:
Scott Augustine MD
CEO
Augustine Surgical Inc.
scottaugustinemd at augbiomed.com