Evaluation of CompleteFTTM placental allograft in clinical practice across wound etiologies

Abstract

Aim: The complex nature of chronic wounds requires care that is not limited to general Standard of Care (SoC) approaches like debridement, wound dressings, negative pressure therapy, hyperbaric oxygen therapy, and of the like. Cellular, acellular, and matrix-like products (CAMPs), such as amniotic membranes, are a prospective solution to these challenges. A growing body of efficacy and safety evidence suggests placental derived allografts have successfully been applied alongside SoC in heterogenous populations with complex comorbidities. The present analysis examines wound closure performance across wounds of varying pathologies characterized by prior lack of improvement under SoC alone.

Methods: In this single-center retrospective study, wound size and associated duration of closure was analyzed. During each visit, care consisted of debridement followed by application of the full-thickness placental allograft, CompleteFT. Wound characteristics and size measurements were captured prior to allograft application. Dimension analysis was conducted to evaluate wound closure efficacy over time. 

Results: A total of 7 wounds across 5 patients (Male: 4, Female: 1) were analyzed as part of this study; etiologies include venous ulcers (n=3), pressure ulcers (n=1) and Mohs defects (n=2). Cumulatively, wounds showed a consistent Percent Area Reduction over time, with 100% wound closure observed for all patients post final allograft application. High coefficients of determinations, ranging from 0.77 to 0.97, per wound further indicates consistent size attenuation overtime until complete closure was reached.

Conclusions: Findings indicate that full-thickness placental allografts, such as CompleteFT, are an effective, less invasive application which can support wound closure across multiple wound types.  Implementing these supportive allografts within wound care could result in improved patient quality-of-life and cost savings while decreasing clinic visits, complications like infections, and surgical needs.