More evidence is needed to determine the efficacy and safety of negative pressure wound therapy in the home setting, according to a technology assessment released Sept. 15 by the U.S. Department of Health and Human Services.
The review was conducted by researchers with the Johns Hopkins University Evidence-based Practice Center, through a contract with the Agency for Healthcare Research and Quality, Rockville, Md. The report is intended to help patients, clinicians, policymakers and health system leaders make well-informed decisions and improve the quality of healthcare.
For the analysis, investigators searched four databases: Medline, Embase, the Cochrane Central Register of Controlled Trials and the Cumulative Index to Nursing and Allied Health Literature.
Two independent reviewers screened the search results and included studies examining the use of NPWT in patients with chronic wounds including venous leg ulcers, arterial leg ulcers, diabetic foot ulcers, pressure ulcers and chronic wounds with mixed etiology.
The reviewers specifically searched for comparative trials that tracked patients in a home setting.
Researchers pulled 5,912 citations, of which seven met the criteria for inclusion. Six of the included studies compared NPWT devices with other wound care methods. One study compared two different NPWT devices. Three of the studies included patients with diabetic foot ulcers and arterial ulcers, three included patients with pressure ulcers, one included patients with venous insufficiency ulcers and two included patients with mixed types of ulcers on the lower extremities.
Data from these studies were limited based on varying study design, small sample size, type of comparator groups and limited outcomes reporting. Most of the studies were observational or retrospective, the researchers found. Only one of the seven selected studies was a randomized controlled trial, and its findings were rated as fair quality, mostly because of the small sample size. Six of the studies were at least in part funded by a device manufacturer, and the remaining study did not list a funding source, the reviewers found.
Unfortunately, the reviewers wrote, the available evidence was insufficient to draw any conclusions of the efficacy and safety of NPWT in a home care setting. The assessment revealed several gaps in research, especially a lack of standardized ways of defining wound eligibility, interventions and outcomes, the report states.
Given that patients with chronic wounds are medically complex, studies should include patients with a specific type of chronic wound and provide details about the characteristics of the wound, the reviewers wrote. The underlying medical comorbidities play a role in wound healing, thus studies need to clearly describe, and as appropriate, adjust for or provide subgroup analysis based on these characteristics.
The reviewers also called for larger, prospective studies for each type of chronic wound treated using NPWT and for comparison of the devices and device components.
Wound care treatment is complex, and future studies should provide details about the treatment protocols for both the NPWT and control groups, the authors wrote. Careful descriptions of the care prior to and/or concurrent to NPWT or their comparison groups should be made, given the wide array of available wound care products, modalities and adjunctive treatments.
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 authors concluded.