Imbed Biosciences Inc. has distributed a press release with the results of a prospective clinical evaluation of its next-generation wound matrix, Microlyte SURGICAL, in diabetic patients undergoing foot and ankle surgery who would ordinarily be at risk of a surgical site infection. Results will be published in the October issue of WOUNDS, a widely read, peer-reviewed journal in wound care and research.
In the study conducted by Ryan Chatelain, DPM at East Tennessee State University, 22 diabetic patients with neuropathy, infection, open wounds, history of recurrent infection, nonhealing wounds, and/or peripheral vascular disease, were included. All patients were at-risk for surgical site infection (SSI) due to the sequelae of diabetes. The overall SSI rate for the diabetic patient is 13%, and the study’s primary objective was to decrease this rate to 6.5% by prophylactic treatment with Microlyte SURGICAL wound matrix. Patients were assessed on day 3 or 5 for SSI incidence. The per-protocol patient population (20/22) had a 0% SSI rate with healing times typical to each procedure (between 10 and 34 days). Two non-compliant patients were excluded from the analysis. “The findings of this preliminary study are exciting! Microlyte seems to offer a much-needed layer of protection for at-risk surgical groups,” said Chatelain.
“These results energize our commitment to educate clinicians across the world about the benefits of Microlyte for improving outcomes in advanced wound and surgical care,” said Ankit Agarwal, Ph.D., co-founder and CEO of Imbed.
Imbed plans to continue conducting clinical studies in surgical procedures that typically have high SSI rates, such as ventral hernia repairs, Caesarean section, and colorectal surgeries.
The results are reported in: Chatelain R. “The efficacy of a novel silver-containing bioresorbable microfilm matrix in at-risk surgical wounds: a clinical case series.” Wounds. 2021; 33(10): 245–252.