Clinical Application of Bioresorbable, Synthetic, Electrospun Matrix in Wound Healing

Matthew MacEwan, Lily Jeng, Tamás Kovács, Emily Sallade, Matthew MacEwan, Lily Jeng, Tamás Kovács, Emily Sallade

Abstract

Electrospun polymeric matrices have long been investigated as constructs for use in regenerative medicine, yet relatively few have been commercialized for human clinical use. In 2017, a novel electrospun matrix, composed of two synthetic biocompatible polymers, polyglactin 910 (PLGA 10:90) and polydioxanone (PDO) of varying pore and fiber sizes (i.e., hybrid-scale) was developed and cleared by the FDA for human clinical use. The present review aims to explain the mechanism of action and review the preclinical and clinical results to summarize the efficacy of the matrix across multiple use cases within the wound care setting, including an assessment of over 150 wounds of varying etiologies treated with the synthetic matrix. Clinical data demonstrated effective use of the synthetic hybrid-scale fiber matrix across a variety of wound etiologies, including diabetic foot and venous leg ulcers, pressure ulcers, burns, and surgical wounds. This review represents a comprehensive clinical demonstration of a synthetic, electrospun, hybrid-scale matrix and illustrates its value and versatility across multiple wound etiologies.

Keywords: Restrata; electrospinning; extracellular matrix; soft tissue repair; wound healing.

Conflict of interest statement

M.M., L.J., E.S. and T.K. declare employment and stock/stock options from Acera Surgical. M.M. is a patent holder for the synthetic hybrid-scale fiber technology discussed in this review (Restrata®).

Figures

Figure 1
Figure 1
A graphical abstract demonstrating the electrospinning process and the microscopic appearance of the synthetic hybrid-scale fiber matrix, as well as its appearance in the wound bed.
Figure 2
Figure 2
Synthetic hybrid-scale fiber matrix—(A) representative image of gross appearance and (B) scanning electron microscopy image.
Figure 3
Figure 3
Histology images of full-thickness wounds stained with hematoxylin and eosin (H&E) at days 15 (A,B) and 30 (C,D) treated with the synthetic matrix (A,C) or the bilayer xenograft (B,D). Results showed that the synthetic matrix had less inflammation and faster filling of the wound bed with granulation tissue compared to the xenograft matrix. G—granulation tissue; T—area of granulation tissue containing inflammation and wound matrix; A—area of abscessation; S in (B)—seroma (edema) formation; S in (D)—serocellular debris; I—inflammation within granulation tissue; arrowheads in (B)—hemorrhage within wound bed; arrowheads in (c)—epithelium; arrowheads in (D)—small microgranulomas; arrows—blood vessels.
Figure 4
Figure 4
Representative images of progressive healing following treatment with the synthetic hybrid-scale fiber matrix. Case 1 diabetic foot ulcer at (A) week 0, (B) week 2, (C) week 4, and (D) complete healing at week 6. The scale bar represents 1 cm. Case 2 diabetic foot ulcer at (E) week 0, (F) week 5, (G) week 8, and (H) complete healing at week 12. Case 3 diabetic foot ulcer at (I) week 0, (J) week 1, (K) week 2, and (L) complete healing at week 4.
Figure 5
Figure 5
Treatment of a representative 5-year venous leg ulcer using the synthetic hybrid-scale fiber matrix. (A) Week 0, (B) week 5, and (C) complete healing at week 24. Scale bars represent 1 cm.
Figure 6
Figure 6
(A) A representative wound after TMA surgery. A strip of the synthetic hybrid-scale fiber matrix was applied over the closed wound. (B) A representative image of a healed TMA wound after treatment with the synthetic matrix. Scale bar represents 1 cm.
Figure 7
Figure 7
A representative Post-Mohs wound that healed over time following treatment with the synthetic hybrid-scale fiber matrix. (A) Squamous cell carcinoma (SCC) at the left posterior helix, (B) the resultant Mohs defect post-micrographic surgery, and (C) 2 weeks, (D) 3 weeks, (E) 5 weeks, and (F) 7 weeks after application of the synthetic hybrid-scale fiber matrix. Complete re-epithelialization was observed at 7 weeks. Scale bar represents 1 cm.
Figure 8
Figure 8
Tendon repair using the synthetic hybrid-scale fiber matrix. Scale bar represents 1 cm.

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