Spiracur Announces Final Results From Multi-Center Randomized Controlled Clinical Trial
- Tue, 5/8/12 - 3:26pm
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The final results of a 17-center prospective randomized-controlled clinical trial evaluating the safety and efficacy of Spiracur Inc’s (Sunnyvale, CA) SNaP® 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 have been published in the May-June 2012 issue of Wound Repair and Regeneration. It is the first-ever comparative effectiveness study of its kind in the field.
Performed under the guidance of David G. Armstrong, DPM, MD, PhD; William A. Marston, MD; Alexander M. Reyzelman, DPM; and Robert S. Kirsner, MD, PhD, 132 patients with lower extremity wounds were enrolled in the study 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.
To establish non-inferiority to traditional NPWT, this study was powered assuming 80 percent wound closure with an 18.5% standard deviation for both groups at 16 weeks using a margin of non-inferiority of 12.5%. 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 4, 8, 12, and 16 weeks (P = 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.
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