Initial clinical assessment of a novel multifunctional topical ointment for difficult-to-heal wounds: a case series.

Chronic wounds are characterized by prolonged inflammation, bacterial bioburden, and ischemia. These factors represent the barriers to wound healing that need to be addressed in order to achieve wound closure. The authors performed the initial clinical testing of WinVivo Wound Ointment ("WinVivo"), a novel topical ointment containing several botanicals that have been previously shown to promote favorable wound environment and advance wound healing. In this series of 13 patients with difficult-to-heal lower-extremity wounds, WinVivo was well tolerated and demonstrated the ability to simultaneously support granulation tissue formation; decrease the amount of exudate, edema, and malodor; and reduce pain. The ulcers included in this study have been present for a minimum of 3 weeks and a maximum of 5 years prior to the start of treatment with WinVivo. Eight of 13 wounds have previously been treated with at least 1 type of advanced wound healing modality, such as dermal substitutes or negative-pressure wound therapy. Treatment with WinVivo lasted for 3 to 12 weeks and resulted in a mean 88% wound closure, with 4 wounds healing completely. In addition to significant reduction in wound size, all patients have exhibited other clinical benefits, suggesting overall improvement in wound conditions. Future studies in a larger population, as well as case-control studies comparing WinVivo with a standard of care, are therefore warranted to further evaluate the efficacy of this new treatment.

Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial.

The purpose of this study was to compare the ultraportable mechanically powered Smart Negative Pressure (SNaP(®)) Wound Care System to the traditional electrically powered Vacuum-Assisted Closure (VAC(®)) Therapy System in the treatment of chronic lower extremity wounds. This 12-center randomized-controlled trial of patients with noninfected, nonischemic, nonplantar lower extremity wounds had enrolled 65 patients, as of January 5, 2010, at the time of a planned interim analysis. Subjects were randomly assigned to treatment with either the SNaP(®) or VAC(®) Systems. The trial evaluated treatment for up to 16 weeks or till complete closure was achieved. Fifty-three patients (N=27 SNaP(®), N=26 VAC(®)) completed at least 4 weeks of therapy. Thirty-three patients (N=18 SNaP(®), N=15 VAC(®)) completed the study with either healing or 16 weeks of therapy. At the time of planned interim analysis, no significant differences (p=0.99) in the proportion of subjects healed between the two devices evaluated were found. In addition, the percent wound size reduction between treatment groups was not significantly different at 4, 8, 12, and 16 weeks, with noninferiority analysis at 4 weeks of treatment reaching the p-value <0.05 significance level (*p=0.019). These interim data suggest no difference in wound closure between the SNaP(®) System and the VAC(®) System in the population studied. We look forward to the final analysis results.