Clinical Evidence

Modern health care is evidence-based. Below you will find a selection of different evidence related to the Spincare System. More and different evidence is constantly being given and will be offered in near future.

Articles

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Outcome of Facial Burn Injuries Treated by a Nanofibrous Temporary Epidermal Layer

The face is commonly affected in thermal injuries, with a demand for proper recognition and the correct choice of treatment to guarantee optimal aesthetic and functional outcomes. It is highly vascularized and often heals conservatively, highlighting the particular relevance of conservative treatment modalities, many of which require daily re-applications or dressing changes, which can be painful and tedious for both the patient and the healthcare providers. Motivated by encouraging results of a novel temporary nanofibrous epidermal layer, we herein present a case series of this technology in a case series of patients suffering from facial burns and treated in our Burn Center. Patients and Methods: Patients with superficial partial-thickness facial burns and mixed pattern burns, which were treated with SpinCare™, an electrospun nanofibrous temporary epidermal layer, between 2019 and 2021, at our institution were analyzed retrospectively.

Vasella, M., Cirebea, J., Gousopoulos, E., Wang, A., Schweizer, R., Waldner, M., Grieb, G., Buehler, P., Plock, J. A., & Kim, B. S. (2023, August 13). Outcome of Facial Burn Injuries Treated by a Nanofibrous Temporary Epidermal Layer. Journal of Clinical Medicine, 12(16), 5273. https://doi.org/10.3390/jcm12165273

Summary poster

Personalized burn treatment: bedside electrospun nanofiber scaffold with cultured autologous keratinocytes: a case study

Grafting healthy autologous skin from a donor site to the damaged areas remains the gold standard treatment for extensive burn wounds, nearly four decades after cultured epidermal autografts (CEA) were initially used. Furthermore, the clinical use of current skin substitutes is constrained. Spincare®, a portable wound care system, involves direct on-site application of an electrospun polymer nanofibrous matrix. The innovative method mimics epidermal-dermal connective tissue structure, promoting cellular regeneration and enhancing wound healing. Additionally, a personalized treatment strategy is suggested for hard-to-heal regions, involving not only CEA, but also the direct application of suspended autologous keratinocytes integrated with in situ Spincare matrix onto the wound bed, allowing for larger wound coverage than CEA.

Segni, A. D., BenShoshan, M., Harats, M., Melnikov, N., Barzilay, C. M., Dothan, D., Liaani, A., Kornhaber, R., & Haik, J. (2023, July 2). Personalised burn treatment: bedside electrospun nanofibre scaffold with cultured autologous keratinocytes: a case study. Journal of Wound Care, 32(7), 428–436. https://www.magonlinelibrary.com/doi/abs/10.12968/jowc.2023.32.7.428

Advances in the Use of Electrospun Nanofibrous Polymeric Matrix for Dermal Healing at the Donor Site After the Split-Thickness Skin Graft Excision: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study

Dressings used to manage donor site wounds (DSWs) have up to 40% of patients experiencing complications that may cause suboptimal scarring. We evaluated the efficacy and safety of a portable electrospun nanofibrous matrix that provides contactless management of DSWs compared with standard dressing techniques. This study included adult patients who underwent an excised split-thickness skin graft (STSG) with a DSW area of 10 to 200 cm2. Patients were allocated into two groups; ie, the nanofiber group managed with a nanofibrous polymer-based matrix, and the control group managed using the standard of care such as Jelonet® or Biatain® Ibu dressing. Primary outcomes were postoperative dermal healing efficacy assessed by Draize scores. The time to complete re-epithelialization was also recorded. Secondary outcomes included postoperative adverse events, pain, and infections during the first 21 days and extended 12-month follow-up. The itching and scarring were recorded during the extended follow-up (months 1, 3, 6, 9, and 12) using Numerical-Analogue-Score and Vancouver scores, respectively. The nanofiber and control groups included 21 and 20 patients, respectively. The Draize dermal irritation scores were significantly lower in the nanofiber vs control group (Z = −2.509; P = .028) on the first postoperative day but became similar afterward (Z ≥ −1.62; P ≥ .198). In addition, the average time to re-epithelialization was similar in the nanofiber (17.9 ± 4.4 days) and control group (18.3 ± 4.5 days; Z = −0.299; P = .764), so were postoperative adverse events, pain, and infection incidence, itching and scarring. The safety and efficacy of electrospun nanofibrous matrix are similar to standard wound care allowing its use as an alternative donor site dressing following the STSG excision.

Haik, J., Ullman, Y., Gur, E., Ad-El, D., Egozi, D., Kruchevsky, D., Zissman, S., Biros, E., Nir, R. R., Kornhaber, R., Cleary, M., & Harats, M. (2021, November 9). Advances in the Use of Electrospun Nanofibrous Polymeric Matrix for Dermal Healing at the Donor Site After the Split-Thickness Skin Graft Excision: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study. Journal of Burn Care & Research, 43(4), 889–898. https://doi.org/10.1093/jbcr/irab216

Our initial experience in the customized treatment of donor site and burn wounds with a new nanofibrous temporary epidermal layer

Recently, electrospinning technology has gained increasing attention for wound care. Spincare® electrospun polymer
nanofibrous temporary epidermal layer is one of the latest developments in the market. Our objective was to explore the potential use
of the new Spincare® system for treating burns and wounds.

Schulz A., Fuchs P.C., Heitzmann W., Kanho C.H., Schiefer J.L. (2021). Our initial experience in the customized treatment of donor site and burn wounds with a new nanofibrous temporary epidermal layer. Annals of Burns and Fire Disasters – vol. XXXIV – n. 1.

The Feasibility of a Handheld Electrospinning Device for the Application of Nanofibrous Wound Dressings

The aim of this study was to determine the feasibility of a portable electrospinning device for the application of wound dressings.

Used on partial thickness wounds, polymer electrospun nanofiber dressings provide excellent surface topography and are a nontouch, feasible, and safe method to promote wound healing with the potential to reduce wound infections. Such custom-made nanofibrous dressings have implications for the reduction of pain and trauma, number of dressing changes, scarring, and an added cost benefit.

Haik, J., Kornhaber, R., Blal, B., & Harats, M. (2017). The feasibility of a handheld electrospinning device for the application of nanofibrous wound dressings. Advances in wound care, 6(5), 166-174.

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