Spiracur Announces Final Results From Multi-Center Randomized Controlled Clinical Trial
Results Support Efficacy and Safety of Spiracur's Mechanically Powered SNaP Wound Care System and Non-Inferiority Compared to Electrically Powered VAC System
(firmenpresse) - SUNNYVALE, CA -- (Marketwire) -- 05/08/12 -- ., developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, today announced the final results of a 17-center prospective randomized-controlled clinical trial evaluating the safety and efficacy of its Wound Care System for the treatment of chronic lower extremity wounds, and non-inferiority compared to the electrically powered KCI V.A.C.® Therapy System. Final results from the pivotal study are published in the May-June 2012 issue of , the official peer-reviewed journal of the Wound Healing Society. It is the first-ever comparative effectiveness study of its kind in the field.
Performed under the guidance of , DPM, M.D., Ph.D., William A. Marston, M.D., Alexander M. Reyzelman, DPM and Robert S. Kirsner, M.D., Ph.D., 132 patients with lower extremity wounds were enrolled in the and randomly assigned to treatment with either the SNaP or VAC Systems. Of the 118 patients who received treatment, 115 patients had follow-up data available for analysis, and 83 patients completed the study with either healing (complete closure of the ulcer) or 16 weeks of therapy.
"The final results are very encouraging for negative pressure wound therapy in general and especially for many patients who are well suited for treatment with portable systems. The data suggest that the ultraportable device studied leads to an even more positive impact on patients' quality of life during treatment," said Dr. Armstrong, professor of surgery at the University of Arizona and principal investigator of the study. "In addition, the results are critical for those of us dedicated to healing wounds and preventing amputations. For patients with smaller wounds that would benefit from NPWT, the mechanically powered SNaP device is proven to be a viable and effective therapy choice."
To establish non-inferiority to traditional NPWT, this study was powered assuming 80 percent wound closure with an 18.5 percent standard deviation for both groups at 16 weeks using a margin of non-inferiority of 12.5 percent. For final analysis, a Wilcoxon Rank Sum Test was conducted on 115 patients from 17 centers. Results indicate that the SNaP-treated subjects demonstrate non-inferiority to the VAC-treated subjects at four, eight, 12 and 16 weeks (p-value = 0.0030, 0.0130, 0.0051 and 0.0044 respectively). Non-inferiority was demonstrated between the two therapies in percent wound size reduction to the *p < 0.05 significance level. The study also found no significant differences in wound-related complications such as wound infections.
The study's secondary endpoints included time for dressing change and Quality of Life (QOL) measurements. For all follow-up visits combined, the mean application time for the VAC System was 18.22 minutes, while the mean application time for the SNaP System was just 10.22 minutes.
The SNaP System was proven significantly better compared to the VAC in multiple areas including less interference in daily activities; less interruption in sleep; less impact on social activities; and improved comfort. In addition, results show there is a higher overall satisfaction with the SNaP device as well as a higher willingness to use the device again, compared to the VAC system.
"We are very happy with the final results of this study, which clearly demonstrate the clinical capabilities and effectiveness of our innovative SNaP System, said chief medical officer, Spiracur Inc. "We have proven the same outcomes with this therapy, while delivering it in a significantly improved way that is beneficial to the . These results underscore a specific need for the SNaP System, thereby opening up exciting opportunities for Spiracur and the broader adoption of our elegant, yet simple system."
Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The SNaP Wound Care System was cleared by the U.S. Food & Drug Administration (FDA) in August 2009 in a new therapy category defined as "non-powered" NPWT devices, and the company obtained CE Mark for the device in December 2010. For more information, please visit .
Spiracur, Spiracur logo and SNaP are registered trademarks of Spiracur Inc.
VAC is a registered trademark of Kinetic Concepts, Inc.
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Datum: 08.05.2012 - 12:35 Uhr
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