SUNNYVALE, Calif. - March 8, 2011 - Spiracur® Inc., the developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, today announced encouraging interim 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 study was published in the March-April 2011 issue of Wound Repair and Regeneration, the official peer-reviewed journal of the Wound Healing Society.

The 12-center randomized-controlled trial (RCT) was performed under the guidance of 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 purpose of the study was to compare the ultraportable mechanically powered SNaP (Smart Negative Pressure) Wound Care System to the traditional electrically powered Vacuum-Assisted Closure (VAC®) Therapy System in the treatment of chronic lower extremity wounds. The trial enrolled 65 patients with lower extremity wounds who were randomly assigned to treatment with either the SNaP or VAC Systems. The trial evaluated treatment for up to 16 weeks, or until there was complete closure of the ulcer.

According to Dr. Armstrong, professor of surgery at the University of Arizona and principal investigator of the study, "The results from this trial are important for those of us dedicated to healing wounds and preventing amputations, as the SNaP System offers an important tool for treating these chronic conditions. This novel technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options."
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.

The study's secondary endpoints included time for dressing change and Quality of Life (QOL) measurements. Results for device application time showed that patients required 21 minutes to apply the VAC System and only nine minutes to place the SNaP System on the wound area. QOL surveys demonstrated no significant differences in reported pain, perceived effectiveness and patient satisfaction between the devices, however, the SNaP System interfered less with overall activity, sleep and social interaction than the VAC System. When asked if they were able to work and perform normal daily activities while being treated with the NPWT device, 92.4 percent agreed that they could work and perform daily activities using the SNaP System compared to 33.3 percent of patients using the VAC System. One hundred percent of the patients using the SNaP System said the noise of the device never bothered them compared to 33.3 percent of patients using the VAC System. When asked about sleep disruption, 100 percent of patients using the SNaP System said the device did not bother them while trying to go to sleep, yet 41.7 percent of patients using the VAC System felt that their sleep was disrupted by the device.

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