Global burden to local action: A pilot feasibility study of placental-based solutions for complex pressure ulcers using real-world evidence
DOI:
https://doi.org/10.63676/d2k9hw29Keywords:
Pressure ulcer, Pressure injury, amniotic tissue membrane, placental allograft, Real-world evidence, chronic wounds, matched cohort studyAbstract
Objective: To conduct a pilot feasibility assessment of a human amniotic tissue membrane (ATM) plus standard of care (SOC) compared with SOC alone in the treatment of pressure ulcers (PrUs) using real-world evidence from a national wound care database.
Method: A multicenter retrospective matched-cohort study was conducted using de-identified electronic health record data extracted from the U.S. Wound Registry/Intellicure database, using records collected between February 2017 and December 2025. Adults with PrUs treated with ATM plus SOC or SOC alone were identified. Nearest-neighbor Mahalanobis matching balanced cohorts by demographic, comorbidity, mobility and wound-specific variables. Outcomes included percentage area reduction (PAR), wound healing trajectory, and composite clinical outcomes.
Results: Following matching, 182 patients were included (91 ATM; 91 SOC). Cohorts were well balanced at baseline for age, sex, comorbidities, wound stage, tissue exposure and wound location. ATM-treated wounds were older and slightly larger at treatment initiation, but ATM was applied earlier following presentation to specialist care. Mean wound size reduction did not significantly differ between groups; however, ATM-treated wounds demonstrated a more favorable overall clinical trajectory. Healing or healed outcomes were observed in 63.7% of ATM-treated wounds compared with 48.4% in the SOC group (p=0.0449). Smoothed PAR trajectories suggested a trend toward greater wound improvement over time in the ATM cohort. Missing outcome data were more common in the SOC group and should be considered when interpreting comparative results.
Conclusion: Although ATM was not associated with a statistically significant improvement in PAR, ATM-treated wounds were more frequently classified as healing or healed based on clinician-assessed outcomes.
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Data Availability Statement
The data that support the findings of this study were obtained from the U.S. Wound Registry (USWR) and the Intellicure electronic health record database. The datasets analyzed during the current study contain protected and proprietary information and are not publicly available.
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