Observations in Acellular Porcine Liver Collagen Scaffold* Case Series for Evidence Based Applications to Real World Prospective Randomized Controlled Trials in Wound Healing

Introduction: Tissue scaffolds are a wound care option to complement other existing techniques. We report herein our cases to better learn how acellular porcine liver collagen scaffold* can best be used and how this knowledge might drive prospective randomized controlled trials in wound healing.Methods:Adults with a wide variety of chronic ulcerations were selected and consented to receive the acellular porcine liver scaffold,* be photographed and followed. Patients selected had ulcerations not healed over prolonged periods of time despite all good local and systemic care.  Acellular porcine liver scaffold* was placed into their ulcerations using a variety of methods from sutured partial closure to steri-strips.  Non-adherent fluid permeable contact layers and supportive secondary dressings were placed, and the patients continued with their usual wound care.  Patients were digitally photographed, measured and interviewed throughout their clinical courses.     Results:Clinicians encounter a wide range of three-dimensional ulcerations that fail to close despite all care measures. Responding ulcerations had variable responses that could be captured by both conventional and digital photographic measurements with 33% – 90% reductions in volumes that persisted.  Some ulcerations receiving more than one placement had on-going positive effects upon closure rates.  Some ulcerations remained more recalcitrant to closure than others.  Placement was safe and well tolerated.  Discussion: Standardized assessments remain challenging across wound sub-types.  Digital photography and software management strategies offer material improvements in standardization, needed for comparisons across patient wound types, sites and practices. Acellular porcine liver collagen scaffold* placement improved closure rates and contemporary wound care metrics.  Recipients felt an improved quality of life as their ulcerations had responded favorably and participation assisted them in achieving more contemporary quality metrics.  Acellular porcine liver collagen scaffold* and other advanced techniques deserve randomized controlled trials that include costs of care for both patients and health care delivery systems as there is currently equipoise to study their effects and value.  Even traditionally well-managed chronic ulcerations have costs when persisting over time.  Further clinical and biological evaluation of acellular porcine liver collagen scaffold* issue scaffolding may generate more effective patient centered, value-based and comparative-effective based care.   References:Pang, C., Ibrahim, A., Bulstrode, N.W. and Ferretti, P. (2017), An overview of the therapeutic potential of regenerative medicine in cutaneous wound healing. Int Wound J, 14: 450-459. https://doi.org/10.1111/iwj.12735 Negut I, Dorcioman G, Grumezescu V. Scaffolds for Wound Healing Applications. Polymers (Basel). 2020 Sep 3;12(9):2010. doi: 10.3390/polym12092010. PMID: 32899245; PMCID: PMC7563417.