A Multi-center, Prospective Clinical Trial Evaluating the Combination of BlastX and Negative Pressure Wound Therapy (VAC).To evaluate the 4-week healing trajectory/wound area reduction with BlastX/VAC as compared with historical pre-study 4-week healing trajectory data and data from the US Wound Registry.
The study is a prospective, clinical trial designed to evaluate the combination of BlastX™ and VAC® in facilitating healing and reduction in bio-burden in pressure ulcers. After consenting, the ulcers of eligible subjects are treated with BlastX. After a 5 minute dwell time the wound VAC® is applied as per manufacturers guidelines. The subjects return to the center three times per week for dressing changes and application of BlastX. The duration of the trial is four weeks. Subjects undergo study procedures (biopsy for quantitative tissue culture, photography, fluorescence imaging and swabbing for protease testing) on a weekly basis. The standard of care for pressure ulcers will be continued including debridement, off-loading, and nutritional supplementation when appropriate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Blast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy.
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States
Wound reduction in surface area
The number of subjects whose wounds reduce in surface area by more than 40% in four weeks
Time frame: 4 week
Wounds have a reduction in bacterial load
The number of subjects whose wounds have a reduction in bacterial load to below 10\^4 as measured by fluorescence imaging
Time frame: 4 weeks
Wounds have a reduction in inflammatory proteases
The number of subjects whose wounds have a reduction in inflammatory proteases (matrixmetalloproteases 2,8 and 9 and Human Neutrophil elastase as measured with a standardized point-of-care test
Time frame: 4 weeks
Reduction in wound-related pain
The number of subjects who report a reduction in wound-related pain as measured on a Numerical Rating Scale
Time frame: 4 weeks
Incidence of device-related adverse events
The incidence of device-related adverse events (Safety and Tolerability)
Time frame: 4 weeks
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