The Food and Drug Administration has warned clinicians and patients to be vigilant for potentially life-threatening complications with the use of negative-pressure wound-therapy devices.
The agency issued the notification after receiving reports of 6 deaths and 77 injuries associated with NPWT devices. “Most of the deaths reported to FDA occurred at home or in a long-term care facility,” the FDA said.
Bleeding was the most serious complication; it was involved in 6 deaths and 17 injuries. Infections, which played a role in 27 reports, arose from the original open wound or dressing pieces retained in the wound. Overall, 32 injuries involved retention of foam dressing pieces; most of those patients required surgical procedures, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.
The FDA notice listed wound types and conditions for which NPWT is contraindicated, as well as risk factors that should be considered before NPWT is used. (See boxes.)
NPWT is still useful “in the appropriate wounds and in the appropriate areas,” said Dr. Paul Y. Takahashi, an internist and expert in wound care at the Mayo Clinic, Rochester, Minn.
The device is FDA approved and “can help, particularly with preventing amputations. It can help in some situations in which a flap or a skin graft is not appropriate. And it certainly can still be beneficial for wounds that are not healing,” he said in an interview. But “you really have to be well trained in using the negative pressure device, and when you remove it … make sure it's well observed, make sure things are healing in nicely and that you're not having excess bleeding.”
Unlike standard wound dressings, which are changed at least daily, NPWT dressings may not be changed for 3 or 4 days, so complications can go unnoticed in NPWT-treated wounds, he noted.
Staff and patients should be alert for certain problem signs, Dr. Takahashi said. The edges of the wound should remain pink. It's time to become concerned when the edges start turning red or the area becomes painful. Other concerning symptoms include fevers, chills, and changes in blood pressure.
A patient handout and a link to the notification is at www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm
Risk Factors Relevant to NPWT Use
▸ Patients at high risk for bleeding and hemorrhage
▸ Patients on anticoagulants or platelet-aggregation inhibitors
▸ Patients with:
Friable vessels and infected blood vessels
Vascular anastomosis
Infected wounds
Osteomyelitis
Exposed organs, vessels, nerves, tendon, and ligaments
Sharp edges in the wound (e.g., bone fragments)
Spinal cord injury (stimulation of sympathetic nervous system)
Enteric fistulas
▸ Patients requiring:
MRI
Hyperbaric chamber
Defibrillation
▸ Patient size and weight
▸ Use near vagus nerve (bradycardia)
▸ Application of circumferential dressing
▸ Mode of therapy—intermittent versus continuous negative pressure
Source: Food and Drug Administration
Contraindications For NPWT
Necrotic tissue with eschar present
Untreated osteomyelitis
Nonenteric and unexplored fistulas
Malignancy in the wound
Exposed vasculature
Exposed nerves
Exposed anastomotic site
Exposed organs
Source: Food and Drug Administration