Contraindications to the use of negative pressure wound therapy (NPWT) systems include the following conditions as noted by in a 2009 U.S. Food and Drug Administration (FDA) alert: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulae, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ.
In a 2011 update, FDA noted additional deaths and injury reports with NPWT since 2009. Although rare, these complications can occur wherever NPWT systems are used, including hospitals, long-term care facilities, and at home. Bleeding was the cause of the most serious adverse events, including deaths. Most reports of wound infection were related to the retention of dressing pieces in the wounds. FDA recommendations for health care providers include the following: select patients for NPWT carefully knowing that NPWT systems are contraindicated for certain wound types, and patient risk factors must be thoroughly considered before use; assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner; be aware of complications associated with dressing changes such as infection and bleeding; be vigilant for potentially life-threatening complications, such as bleeding; and be prepared to take prompt action if they occur. FDA reported that the safety and effectiveness of NPWT systems in newborns, infants, and children had not been established and, currently, there are no NPWT systems cleared for use in these populations.
Continuation of healing during use of the NPWT system should be monitored on a frequency of not less than every 14 days.
Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.
Powered NPWT systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing such as diabetes control, nutritional status, and relief of pressure.
The focus of these policy statements and guidelines is for the use of NPWT in the outpatient setting.