The federal Agency for Healthcare Research and Quality said in a draft version of its recent technology assessment that it could not determine the safety and efficacy of negative pressure wound therapy (NPWT) technologies in home healthcare settings. Nevertheless, the assessment offers insight into the concerns of healthcare policymakers and will have an impact on federal reimbursement decisions because it will be discussed at an upcoming Medicare Evidence Development & Coverage Advisory Committee meeting, AHRQ says.
Key players in the multimillion dollar industry include Smith & Nephew ($SNN) and wound care specialists Kinetic Concepts and Prospera.
AHRQ says that chronic wounds impose a growing burden on the healthcare system due to the aging population; almost 2% of those older than 65 suffer a venous leg ulcer over the course of a year. NPWT consists of a foam, gauze or other wound dressing that is applied over the wound and then exposed to negative pressure via a vacuum pump.
Although the technology emerged in the 1980's, safety concerns remain. Complications resulted in 12 deaths and 174 injuries between 2007 and 2011, the assessment says. And many of the adverse events occurred at the home--this challenge will only grow larger as NPTW companies seek to capitalize on the home healthcare trend by offering products that can be applied by patients without the need for healthcare workers. In fact, most of the 30 or so models of NPTW can be used in either the hospital or the home, the report shows.
The tech assessment consisted of a detailed literature that resulted in the retrieval of 5,332 citations. Seven studies were reviewed in depth and formed the basis of the agency's determination. Seven others were excluded because they did not stratify data by the setting (home or hospital). Unfortunately the studies were not acceptable by the agency's standards, AHRQ said. It labeled the strength of evidence "insufficient" across all of the report's target populations, consisting of patients with various types of ulcers.
"Standardization of wound care research protocols, such as providing consistency in comparator groups, robust randomized study designs, larger trials, and common definitions of outcomes, would be helpful in providing evidence to inform decisions about the use of NPWT," the agency concluded. It also called for more studies focused on outcomes in the home specifically.
- read the tech assessment