Cryopreserved Placental Membranes Containing Viable Cells Result in High Closure Rate of Nonhealing Upper and Lower Extremity Wounds of Non-Diabetic and Non-Venous Pathophysiology

Abstract

Introduction: Higher closure rates for chronic diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) have been reported for placental products adjunct to standard of care (SOC) vs SOC alone; however, data for other types of wounds are limited.

Objective: This study aimed to evaluate the clinical outcomes of amnion-derived and chorion-derived cryopreserved placental membranes containing viable cells (vCPM) in the treatment of nonhealing upper-extremity and lower-extremity wounds of nondiabetic and nonvenous pathophysiology. The authors hypothesized that treatment with vCPM adjunct to SOC would result in positive clinical outcomes for these wounds.

Materials and methods: Data for all patients consecutively treated between January 2016 and May 2019 with vCPM adjunct to SOC were retrospectively collected and analyzed through chart review at a single center. Patients with wounds of diabetic and venous pathophysiology and patients receiving other skin substitutes during the course of vCPM treatment were excluded from the study. Outcomes included wound closure, time to closure, number of applications, and vCPM-related adverse events (AEs).

Results: Ninety-two patients with 104 wounds received vCPM applications adjunct to SOC. The median wound size was 3.15 cm2 (mean, 12.7 cm2) with a median duration of 1.5 months (mean, 3.9 months). Eighty-seven of the 104 wounds (83.7%) achieved complete wound closure in a median time of 41 days and 3 applications of vCPM. There were no differences in closure rates between upper-extremity and lower-extremity wounds, nor between the amnion and chorion products. There were no vCPM-related adverse events.

Conclusions: This study provides valuable information to physicians, hospitals, and payers as it pertains to medically necessary and appropriate patient treatment.