Wound matrix materials are used to improve the regeneration of dermal and epidermal layers in both acute and chronic wounds. Contemporary wound matrices are primarily composed of biologic materials such as processed xenogeneic and allogeneic tissues. Unfortunately, existing biologic wound matrices possess multiple limitations including poor longevity, durability, strength, and enzymatic resistance required for persistent support for new tissue formation. A fully-synthetic, resorbable electrospun material (Restrata Wound Matrix, Acera, St.Louis, Missouri ) that exhibits structural similarities to the native extracellular matrix offers a new approach to the treatment of acute and chronic wounds. This novel matrix is the first product to combine the advantages of synthetic construction (e.g. resistance to enzymatic degradation, excellent biocompatibility, strength/durability and controlled degradation) with the positive attributes of biologic materials (e.g. biomimetic architecture similar to human extracellular matrix (ECM), fibrous architecture optimized to support cellular migration and proliferation, engineered porosity to encourage tissue ingrowth and vascularization). These features allow RWM to achieve rapid and complete healing of full-thickness wounds that, in preclinical studies, is comparable to Integra Bilayer Wound Matrix (Integra LifeSciences, Plainsboro, New Jersey), a gold standard biologic material with diverse clinical indications in the wound care. Together, this review suggests that the RWM offers a unique fully-synthetic alternative to existing biologic matrices that is effective, widely available, easy to store, simple to apply and low cost.
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.
A fully synthetic electrospun matrix was compared to a bi-layered xenograft in the healing of full thickness cutaneous wounds in Yucatan miniature swine. Full thickness wounds were created along the dorsum, to which these matrices were applied. The wound area was measured over the course of healing and wound tissue was scored for evidence of inflammation and healing. Animals were sacrificed at Day 15 and Day 30 and tissue samples from the wound site were harvested for histopathological analysis to evaluate inflammation and tissue healing as evidenced by granulation tissue, collagen maturation, vascularization, and epithelialization. Average wound area was significantly smaller for treatment group wounds compared to control group wounds at 15 and 30 days ([7.7 cm2 ± 0.9]/[3.8 cm2 ± 0.8]) and ([2.9 cm2 ± 1.1]/[0.2 cm2 ± 0.0]) (control/treatment) (p = 0.002/p = 0.01). Histopathological analysis of wound sections revealed superior quality of healing with treatment group wounds, as measured by inflammatory response, granulation tissue, and re-epithelialization. A fully synthetic electrospun matrix was associated with faster rates of wound closure characterized by granulation tissue, deposition of mature collagen and vascularization at earlier time points than in wounds treated with a bi-layered xenograft. Treatment with this fully synthetic material may represent a new standard of care by facilitating full-thickness wound closure while eliminating the risks of inflammatory response and disease transmission associated with biologic modalities.
ÖZAmaç: Bu çalışmada yaşlılarda çift kolon kırıklarında osteosenteze (plak ve vida tespiti) kıyasla kalça artroplastisi ile desteklenen aynı yöntemin (hibrid çözüm) mekanik stabilitesi karşılaştırıldı. Hastalar ve yöntemler: Çift kolon kırıkları için geliştirilen ileri sonlu eleman pelvis modelinde mekanik araştırmalar yapıldı. İncelenen simüle edilen implant kombinasyonları şunlardı: poliaksiyel vidalı ve U plaklı, halkalı, modüler asetabüler sepet; medial horizontal (linea terminalis) ve kuadrilateral kemik yüzeylerine yerleştirilen poliaksiyel vidalı plaklar; U plaklı, modüler asetabüler kap ve çeşitli ebatlarda sonlu eleman modeline (FEM) göre optimize edilen poliaksiyel vidalar. Bu modellerde yük, gerilim ve implant deformasyonuna bağlı farklı hareket paternlerinden doğan pik yük pozisyonlarındaki muhtemel kaymalar ölçüldü. Bulgular: Hibrid sistemler, piyasada bulunan implantlarda minimum deformasyona neden oldu. Tek başına konvansiyonel osteosenteze kıyasla, asetabüler kırık bölgelerinde daha az muhtemel kayma ve daha yüksek stabilite gözlendi. Mevcut ve uygun implant ebatlarına göre optimizasyon yapıldığında, stabilitede anlamlı düzeyde ilave bir artış izlendi. Sonuç: Yaşlılarda çift kolon kırıklarının tedavisinde biyomekanik modellerde osteosentez ve protez implantasyonunu içeren hibrid yöntem daha fazla stabilite sağlamaktadır.Anahtar sözcükler: Asetabüler kırık, asetabulum, sonlu eleman modeli, pelvik travma, plak osteostentezi, total kalça replasmanı. ABSTRACTObjectives: This study aims to compare mechanical stability of osteosynthesis (plate and screw fixation) alone versus the same method supplemented with hip arthroplasty (hybrid solution) for double column fractures in elderly. Patients and methods: Mechanical investigations were performed on an advanced finite element pelvis model developed for double column fractures. The following simulated implant combinations were analyzed: modular acetabular basket with a ring with polyaxial screws and U-plate; plates with polyaxial screws placed on the medialhorizontal (linea terminalis) and quadrilateral bone surfaces; modular acetabular cup with U-plates; and polyaxial screws in sizes optimized based on a finite element model (FEM). Using the models, the possible shifts in peak load positions arising in different movement patterns caused by load and tension and implant deformation were measured. Results: Hybrid systems resulted in minimal deformation of the implants already available on the market. We observed less possible shifts and greater stability in the acetabular fracture zones, compared to conventional osteosynthesis alone. Optimization with available and compatible implant sizes led to a further significant increase in stability. Conclusion: Hybrid method combining osteosynthesis and prosthesis implantation provide more stability in biomechanical models in the treatment of double column fractures in elderly.
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