New Randomized Controlled Trial
Supports Efficacy And Safety Of Spiracur SNaP Wound Care System
27 Sep 2010 -- Spiracur, Inc. announced important results from a clinical study highlighting the safety and efficacy of its SNaP Wound Care System for the treatment of chronic lower extremity wounds. The data was presented this week at the Fall 2010 Symposium on Advanced Wound Care (SAWC) in Anaheim, Calif.
The 12-center, 65-patient randomized controlled trial (RCT) compared negative pressure wound therapy (NPWT) between the KCI Wound V.A.C. Therapy System and the SNaP Wound Care System for the treatment of chronic lower extremity wounds. The Poster was presented by David G. Armstrong, DPM, M.D., Ph.D., William A. Marston, M.D., Alexander M. Reyzelman, DPM and Robert S. Kirsner, M.D., Ph.D. The subjects were randomly assigned to treatment with either the SNaP System or the V.A.C. System, and the trial evaluated treatment for up to 16 weeks, or until there was complete closure of the ulcer.
Planned interim analysis of the first 65 patients from 12 centers found no significant differences in the proportion of subjects healed between the two devices evaluated or in percent wound size reduction. 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.
According to David G. Armstrong, DPM, M.D., Ph.D., professor of surgery at the University of Arizona and principal investigator on this study, "We have been using the technology for over a year now and our patients have responded well to this new portable therapy. For those of us dedicated to healing wounds and preventing amputations, this device provides an important tool for treating these chronic conditions. This novel technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options."
"We are thrilled to have such positive clinical data presented at SAWC, as they clearly demonstrate the unique opportunity the SNaP Wound Care System offers to patients and clinicians for the treatment of chronic wounds," said Gary Restani, president and chief executive officer, Spiracur, Inc. "The response to our proprietary system has been extremely positive by both patients and clinicians, and we are confident that this new data will help increase awareness for and broaden adoption of the SNaP Wound Care System."
SNaP Wound Care System