Dr. Ron Najafi, CEO of NovaBay, comments on recent CBS News coverage of Dr. John Crew’s successful treatment of a patient afflicted with “flesh-eating” Bacteria
It seems not a week goes by without another news story being reported about the horrific consequences of a patient being stricken with “flesh-eating bacteria.” Well, I have some good news to report. On Friday July 27th, CBS News – San Francisco reported on Dr. John Crew’s innovative new therapy of combining Negative Pressure Wound Therapy (NPWT) and NeutroPhase to save a patient afflicted with “Flesh-Eating” Bacteria (Group A streptococci).
Dr. John Crew, Vascular Surgeon at The Seton Medical Center and his patient, Lori Madsen of Pacifica, CA.
I would like to take this opportunity to simply explain the following without a lot a technical jargon:
- Pathogenesis of “Flesh-Eating Bacteria”
- Current Therapy to treat this dreaded disease
- Dr. John Crew’s innovative therapy (NPWT + NeutroPhase)
- Why NeutroPhase as an irrigation solution has a potential neutralizing effect on toxins generated by “Flesh-Eating Bacteria”
Pathogenesis of Flesh Eating Bacteria
Although “flesh-eating bacteria” is a commonly used term, it is important to note that bacteria do not actually “eat” the tissue. Instead, they cause the destruction of skin and muscle by releasing toxins (virulence factors). Many types of bacteria can product toxins that can harm tissue and muscle.
The infection begins locally at a site of trauma, which may be severe (such as the result of surgery), a minor scratch or scrap, or even non-apparent. Patients usually complain of intense pain that may seem excessive given the external appearance of the skin. With progression of the disease, often within hours, tissue becomes swollen as white blood cells are mounting a defensive response.
In the early stages, signs of inflammation may not be apparent if the bacteria are deep within the tissue. If they are not deep, signs of inflammation, such as redness and swollen or hot skin, develop very quickly. Skin color may progress to violet, and blisters may form, with subsequent necrosis (death) of the subcutaneous tissues.
Furthermore, patients with necrotizing fasciitis typically have a fever and appear very ill. Because the disease can rapidly progress to septic shock, mortality rates have been noted as high as 73 percent if left untreated. Without surgery and medical intervention, the infection will rapidly progress and will eventually lead to the amputation of limbs and even death.
Current Therapy to treat this dreaded disease
Current therapy involves an aggressive course of intravenous antibiotic therapy (treatment often includes a combination of intravenous antibiotics including penicillin, vancomycin, and clindamycin) and aggressive surgical debridement of necrotic tissue which may often lead to multiple amputations and in some cases death.
As evidence of the serious complications that can arise, Aimee Copeland, a healthy young woman from Atlanta, GA was injured in a zip lining accident which led to a flesh eating bacteria infection and multiple amputations.
(A simple Google search for “flesh-eating bacteria” will yield a multitude of disastrous stories).
Dr. John Crew’s Innovative Therapy
John Crew, MD is a vascular surgeon who has worked extensively with NeutroPhase and was the principal investigator on our 54 patient NeutroPhase trial at Seton Medical Center. NeutroPhase is an FDA cleared ADVANCED wound cleanser containing 100 ppm of PURE hypochlorous acid in Saline. Hypochlorous acid maintains an antimicrobial environment in solution and has been cleared by the FDA as a wound cleanser for Stage I-IV diabetic, venous and bed sore ulcers.
What characteristics should an ADVANCED wound cleanser possess?
1) Fast action in killing bacteria (so called: fast time kill)
Pure hypochlorous acid has proven to be remarkably rapid in the time it takes to kill bacteria in solution! This is a critically important criterion for all wound irrigation solutions. In other words, if a wound irrigant is slow in killing bacteria, it will drain out before it can kill bacteria. Pure hypochlorous acid has added advantages over competing products which contain only 40-50% hypochlorous acid combined with sodium hypochlorite (commonly known as bleach) as an impurity. Pure hypochlorous acid is 80-100 times more potent than sodium hypochlorite (common bleach).1
2) Safe to healthy tissue in an open wound
It is unfortunate to note that most wound cleansers on the market today, at a concentration needed to kill bacteria, are also toxic to the healthy cells responsible for wound healing as seen in our laboratory testing.
In Lori Madsen’s case, I am convinced Dr. Crew was able to:
A) Eradicate the Strep A bacteria with classical intravenous antibiotic therapy.
B) Utilize his innovative procedure to neutralize the toxins with a combination of NeutroPhase irrigation and Negative Pressure Wound Therapy (using Kinetic Concept Inc.’s VAC device). Important note – if the poisonous toxin produced by the Strep A infection is left unchecked, since they are NOT neutralized and destroyed by traditional antibiotics, the tissue and muscle damage will continue with potentially dire consequences!!
Why NeutroPhase as an irrigation solution has a potential neutralizing effect on toxins generated by Flesh-Eating Bacteria
NeutroPhase is cleared by the FDA to safely irrigate wounds and remove necrotic tissues. However, laboratory studies have confirmed that NeutroPhase has the ability to neutralize the toxins generated by “flesh-eating” Bacteria and NovaBay is in the process of publishing these results. It is those toxins and not the bacteria that continue to ravage the body’s tissue and muscles, hence the name “flesh eating”. Furthermore, neutralized toxins become more water soluble and can easily be removed by the process of Negative Pressure Wound Therapy which applies a gentle negative pressure to slowly remove exudations generated in the wound. NovaBay is currently planning further studies to increase our understanding of the mechanism of action of this therapy.
In conclusion, I want to thank the NovaBay team for their dedication to creating products that have the potential to change the course of this deadly / life threatening disease. I also want to thank Dr. John Crew for his devotion to his patients.
Ron Najafi, Ph.D.
CEO & Chairman
NovaBay Pharmaceuticals, Inc.
1Hui YH (ed.), 2006. Handbook of food science, technology, and engineering, Vol. 4. p. 193-24. CRC Press, Boca Raton, FL.
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