A Retrospective Analysis of Clinical Use and Outcomes Using Viable Placental Membrane Allografts in Chronic Wounds.

INTRODUCTION: Viable placental membrane (vPM) has been shown to decrease time to healing, adverse wound events, and wound-related infections. Wound research exclusion criteria commonly exclude wound types other than diabetic foot ulcers and venous leg ulcers (VLUs), comorbidities including peripheral arterial disease (PAD) and uncontrolled diabetes mellitus (DM), and wounds with exposed bone or tendon.

OBJECTIVE: This retrospective research study evaluated the clinical use and outcomes of the vPM with living mesenchymal stem cells used in chronic wound management in the community hospital outpatient department setting with the goal of comparing real-world use and outcomes of the product with use and outcomes described in the chronic wound literature.

MATERIALS AND METHODS: A retrospective analysis on vPM treatments at a Wisconsin academic health system's community hospitals. Participants included all patients who received vPM therapy between July 1, 2016, and August 21, 2019.

RESULTS: A total of 89 patients received vPM treatment during the study period (mean age, 70 years; 69% male [n = 61], 31% female [n = 28]). Wound types were 54% diabetic or neuropathic foot ulcers (n = 48), 17% VLUs (n = 15), 7% pressure injuries (n = 6), and 22% atypical wounds (n = 20). The average wound duration prior to vPM initiation was 104 days. Average wound size at presentation was 6.9 cm2. Of study participants 54% had PAD (n = 48), 63% had DM (n = 56), 33.7% had DM and PAD (n = 30), and 17% had exposed bone or tendon (n = 15). Average adjusted time to healing after initiation of vPM was 81.2 days. The percentage of wounds healed 12 weeks after initiation of vPM treatment was 57%.

CONCLUSIONS: Effectiveness of vPM observed in controlled trials also was observed in this real-world study on vPM for multiple wound types, patients with comorbidities including PAD and uncontrolled DM, and wounds with exposed bone or tendon. Results of this study were not statistically different from those reported in the literature. More randomized controlled trials are needed to explore the efficacy of vPM on patient presentations common to wound healing centers.