Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: A multicenter randomized controlled trial.

This study was designed to compare the ultraportable mechanically powered Smart Negative Pressure ( SNaP) Wound Care System ( Spiracur, Sunnyvale, CA) with the electrically powered Vacuum- Assisted Closure ( VAC) Therapy System (Kinetic Concepts, Inc. [ KCI], San Antonio, TX) in a multicenter, compa...

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Publicado en:Wound Repair & Regeneration Vol. 20; no. 3; pp. 332 - 342
Autores principales: Armstrong, David G., Marston, William A., Reyzelman, Alexander M., Kirsner, Robert S.
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Wiley-Blackwell May/Jun2012
Acceso en línea:Ver este registro en EBSCOhost
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      dt: May/Jun2012
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/j.1524-475X.2012.00780.x
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        atl: Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: A multicenter randomized controlled trial.
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          Armstrong, David G.
          Marston, William A.
          Reyzelman, Alexander M.
          Kirsner, Robert S.
        affil: wrr780-aff-0001
      sug:
        subj:
          Negative Pressure Wound Therapy Methods
          Treatment Outcomes
          Human
          Funding Source
          Randomized Controlled Trials
          Leg Ulcer
          Random Assignment
          Kaplan-Meier Estimator
          Multicenter Studies
          Prospective Studies
          Wilcoxon Rank Sum Test
          Survival Analysis
          Data Analysis Software
          Male
          Female
          Middle Age
          Aged
          Aged, 80 and Over
          Descriptive Statistics
          Middle Aged: 45-64 years
          Aged: 65+ years
          Aged, 80 & over
          Male
          Female
      ab: This study was designed to compare the ultraportable mechanically powered Smart Negative Pressure ( SNaP) Wound Care System ( Spiracur, Sunnyvale, CA) with the electrically powered Vacuum- Assisted Closure ( VAC) Therapy System (Kinetic Concepts, Inc. [ KCI], San Antonio, TX) in a multicenter, comparative efficacy, noninferiority-powered, randomized controlled trial. We enrolled 132 people with noninfected, nonischemic, nonplantar lower extremity diabetic and venous wounds. Each subject was randomly assigned (1:1) to treatment with either system in conjunction with appropriate off-loading and compression therapy. The trial evaluated treatment for up to 16 weeks or complete wound closure (defined as complete reepithelialization without drainage). Primary end point analysis of wound size reduction found that SNaP-treated subjects demonstrated noninferiority to the VAC-treated subjects at 4, 8, 12, and 16 weeks ( p = 0.0030, 0.0130, 0.0051, and 0.0044, respectively). Kaplan- Meier analysis showed no significant difference in complete wound closure between SNaP- and VAC-treated subjects at all time points. Device related adverse events and complications such as infection were also similar between treatment groups. These data support similar wound healing outcomes between the SNaP system and the VAC system in the population studied.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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