FDA Urges Caution In Negative Pressure Wound Therapy

People often ask us how high-pressure (HBOT) and low-pressure (NPWT) therapy can both be effective in the treatment of diabetic foot ulcers and other chronic wounds. If one works, the other shouldn't, right? In simplest terms, both hyperbaric oxygen therapy (HBOT) and negative pressure wound therapy (NPWT) promote blood circulation in the healing wound bed. Hyperbaric oxygen works directly through the blood vessels below. Negative pressure, or vacuum, therapy works indirectly through the wound dressing above.

NPWT plays a central role in advanced wound care. Major device manufacturers KCI, Smith & Nephew, and Medela (Mölnlycke) are major contributors to the movement that has swooped up HBOT and helped millions suffering with nonhealing chronic wounds.

Last week the FDA issued a Safety Communication Update on serious complications associated with NPWT. The agency reports "a total of 12 deaths and 174 injury reports since 2007" and notes NPWT contraindications and patient risk factors to consider. Most deaths occurred with use at home or in long-term care facilities. Together the FDA, the industry, and the medical community are educating clinicians and patients and closely monitoring outcomes.

O2.0 is the news blog of HyperbaricLink, the independent web guide to hyperbaric oxygen therapy.