The Efficacy of a 3-D Electrospun Synthetic Polymer Matrix on Difficult-to-heal Wounds

Introduction: The efficacy of a novel 3-D electrospun synthetic polymer matrix (3D-ESPM) on the management of difficult-to-heal wounds was evaluated.

Methods: This prospective case series took place at 4 wound centers. The primary endpoints were the percentage area reduction (PAR) in wound area at 4 and 8 weeks. Secondary endpoints included time to heal and the total proportion of healed wounds at 12 weeks. Standard of care included infection and vascular assessment/management, debridement, moist dressings, offloading [for diabetic foot ulcers (DFUs) and pressure injuries (PIs)], multilayer compression for venous leg ulcers (VLUs), and an air mattress turning schedule for PIs. After applying 3DESPM, the provider rinsed the product and wound with sterile saline to facilitate the polymer degradation process. The provider backed the product with a nonadherent dressing, a secondary dressing, and additional bandages, as necessary, and left on the wound until complete degradation was observed, as appropriate. Multiple applications were applied, as needed and/or available. Combination advanced therapies were applied to some wounds, per physician discretion.

Results: Thirty-eight patients [mean age: 64.3 years (SD: 17.6)] with 50 wounds (mean area: 10.2 cm2, 35 chronic, 70%), were screened and enrolled from February 1, 2019 through June 14, 2021. The mean number of comorbidities per patient was 5.2 (2.4). All wounds were treated with 3DESPM; 35 (70%) completed the study. The mean PAR at 4 and 8 weeks was 67.6% (38%) and 80% (35%), respectively. Thirty-three wounds (66%) healed at 12 weeks. Twelve wounds (24%) received combination advanced therapy with Phoenix; 4 wounds (8%) healed with 3-D ESPM combined with negative pressure wound therapy, hyperbaric oxygen therapy, and/or collagen dressings. The mean time to heal was 40.8 days (25.0 days).

Discussion: In a real-world, complex patient population with severe comorbidities and heterogeneous wounds, 3D-ESPM appeared to accelerate the stalled healing process to contribute to wound closure. To confirm these preliminary findings, a small, randomized controlled trial is under development that will evaluate 3D-ESPM on VLUs, and the effect of 3D-ESPM on DFUs and surgical and trauma wounds is under investigation.