negative pressure wound; therapy devices

Product Name: InfoV.A.C.® Therapy Unit, Invia Liberty Wound Therapy, V.A.C.® Freedom™, ActiV.A.C.® Therapy Unit, ConvaTec Engenex® NPWT system, Exusdex® wound drainage pump, EZCARE Negative Pressure Wound Therapy, EZCARE Negative Wound Therapy, Engenex® Advanced NPWT System, Invia Vario 18 c/i Wound Therapy, NPD 1000 Negative Pressure Wound Therapy System, Prodigy™ NPWT System, PRO-III™, PRO-II™, PRO-I™, RENASYS™ EZ Negative Pressure Wound Therapy, SVEDMAN™ and SVED™ Wound Treatment Systems, V.A.C.® ATS™, V.A.C.® Instill System, V1STA Negative Pressure Wound Therapy, V1STA Negative Wound Therapy, Venturi™ Negative Pressure Wound Therapy
Country: None

US Agency for Healthcare Research and Quality

Outcome Measure

a. Efficacy: Quality of life, complete wound closure, time to complete wound healing (skin closure without drainage or dressing requirements), improvements in wound care (infection, impact on the incidence of other problems, such as sepsis, edema, or amputation), satisfaction with treatment, duration of treatment, and survival, Intermediate outcomes: time to 50% reduction of wound volume, percent change in wound volume, and improved wound condition<br>b. Safety: Pain, bleeding, infection/ bacterial load, other complications, mortality (p. 50ff)

Body Classification

Skin, Hair and Nails

Device Type

Therapeutic device

Device Category

Treatment of disease

Risk Classification

IIb

Indication

chronic and acute Wounds (Pressure ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Traumatic wounds, Post-operative and dehisced surgical wounds, Explored fistulae, Skin flaps and grafts, subacute, dehisced wounds, partial-thickness burns)

ICD-10

L89, E14.5, I87.2, T79.3, T81.4,

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