Negative Pressure Wound Therapy Warnings

Mon, 12/14/2009 - 4:33am

The FDA recently advised healthcare providers over a growing concern related to rare, but potentially fatal complications from negative pressure wound therapy. The therapy involves a device that uses a vacuum pump to produce sub-atmospheric pressure over a chronic wound or burn.

Although the procedure can aid healing and closing of wounds by creating a vacuum to remove excess fluid and infected material, the FDA noted that bleeding and infection can occur. Complications associated with the therapy have resulted in six patient deaths, as well as 77 related injuries.

Specifically, for patients using this type of therapy at home, the FDA recommends:

  • Training from a health professional for the patient and home caregiver, including a clear understanding about the length of the therapy, potential complications and warning signs.
  • Get advice from a healthcare professional about using or discontinuing aspirin or other medicines that affect bleeding or clotting. Bleeding was the most serious complication associated with the negative pressure system. Extensive bleeding occurred in patients with blood vessel grafts in the leg, breastbone and groin, as well as those taking medication for blood clots and while dressings attached to tissue were removed.
  • Infection was another major problem, typically occurring when pieces of dressing remained in the wound. Most who experienced additional infection required surgery, further hospitalization and antibiotics.

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