Diabetic ulcers were 59% more likely to close in the treatment cohort, compared to the control cohort
Misonix, a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative products that enhance clinical outcomes, announced today the recent publication of two new large real-world studies that further prove the clinical effectiveness of its all human split thickness skin allograft TheraSkin® for the treatment of complex wounds.
Results of the studies were published in Wound Repair and Regeneration and International Wound Journal.
“We are very pleased with the results of these two large retrospective propensity matched-cohort studies offering further proof that TheraSkin is a highly effective tool for clinicians treating hard to heal wounds,” stated Dr. Arti Masturzo, Chief Medical Officer at Misonix.
“In studies of over 3,990 lower extremity wounds of all etiologies and over 1,550 diabetic wounds, TheraSkin showed higher healing rates, lower medical transfers, higher completion rates, and lower recidivism rates compared to standard of care, providing added confirmation on the efficacy and validity of TheraSkin on the treatment of real world complex wounds of all etiologies and depths.”
Data published from the studies show that patients treated with TheraSkin experienced improvements in the treatment of complex wounds including:
Diabetic ulcers were 59% more likely to close in the treatment cohort, compared to the control cohort.
The healing rate with the graft was statistically better than standard of care across multiple subsets, with the most significant improvement noted in the worst wounds that had a duration of 90‐179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04).
Furthermore, the decrease in ulcer recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without exposed deep structures (p < 0.05).
The amputation rate in the treatment cohort was 42% less than that of the control cohort.
TheraSkin treated wounds were more likely to close (68% versus 60%), particularly wounds with exposed structures (64% versus 50%) and with lower recidivism at 6 months (25% versus 28%).
“In this retrospective matched-cohort study of over 1,550 diabetic wounds, wounds treated with TheraSkin were more likely to heal and remain closed, compared to ulcers treated with standard of care alone. The improved outcomes were noted throughout all complexities and particularly pronounced with older wounds and deep wounds involving bone and tendon,” commented Dr. Adrian Barbul, Professor of Surgery at Vanderbilt University SOM and expert in Wound Healing.
Source: Company Press Release