Efficacy of a 3D Electrospun Synthetic Polymer Matrix on Hard-to-Heal Wounds.

Abstract

The aim of this study was to evaluate the efficacy of a 3D electrospun synthetic polymer matrix (3DESPM) on hard-to-heal wounds. This prospective case series took place at four sites. The primary endpoints were the percentage area reduction (PAR) in wound area at four and eight weeks. Secondary endpoints included time to heal (Kaplan-Meier analysis) and the proportion of healed wounds at 12 weeks. After applying 3DESPM, the physician applied sterile saline, as appropriate, to adhere the matrix to the wound bed and facilitate the polymer degradation process. A nonadherent dressing, a secondary dressing, and additional bandages (as needed) were then applied. The physician left the product on the wound until complete degradation was observed, as appropriate, and reapplied, as appropriate. Combination advanced therapies were applied, per physician discretion. Thirty-eight patients (mean age: 64.3 years [SD: 17.6]) with 50 wounds (35 chronic, 70%) participated. The mean number of comorbidities per patient was 4.4 (2.3). All wounds received 3DESPM; 12 wounds (24%) received combination therapies; and 38 wounds (76%) completed the study. The mean (SD) PAR at four and eight weeks was 67.6% (38%) and 80% (35%), respectively. Thirty-three wounds (66%) healed at 12 weeks. The Kaplan-Meier mean time to heal for all wounds was 49.0 days (95% confidence interval: 41.3-56.7). In a complex patient population with severe comorbidities and heterogeneous wounds, 3DESPM appeared to accelerate the stalled healing process to contribute to wound closure. Further investigation of 3DESPM on a larger patient population and in a controlled setting is pending.