Use of Nevelia Dermal-Epidermal Regenerative Template in the Management of Ischemic Diabetic Foot Postsurgical Wounds

Abstract

The purpose of this cross-sectional study is evaluate the effectiveness of a dermal-epidermal substitute (DES) composed of 3-dimensional porous matrix of type 1, purified, stabilized, bovin-origin collagen (Nevelia, SYMATESE, Chaponost, France) without a subsequent skin graft in the treatment ischemic postsurgical diabetic foot ulcers. This study group was composed of a sample of consecutive diabetic patients with critical limb ischemia and postsurgical wounds. All patients received a preset limb salvage protocol including the application of the DES, but none received a skin graft. Patients were closely followed until wound healing or different outcome. The outcome measures were healing, nonhealing, major amputation, and death evaluated at 1 and 2 years of follow-up. Forty-one patients were included. The average postsurgical wound area was 69.6 ± 50 cm2. Twenty-one patients (51%) healed; 10 patients (24%) did not heal after 1 year of follow-up; however, all of them achieved a mean ulcer size reduction >50%; 7 patients (17%) were amputees; 3 patients (7.3%) died. In a later follow-up (2 years), wounds in 8 additional patients healed. Successful revascularization was an independent predictor of healing (hazard ratio = 5.1, 95% confidence interval [CI] = 2.5-14-9; P = .0001), the postsurgical ulcer size (>50 cm2) was an independent predictor of nonhealing (hazard ratio = 6.2, 95% CI = 2.1-38.4; P = .0001) while recurrence of critical limb ischemia was an independent predictor of major amputation (odds ratio = 3.4, 95% CI = 1.1-4.5; P = .002). The DES composed of type 1 bovin-origin collagen is useful in the treatment of large postsurgical diabetic foot ulcers, even when the skin graft is not a suitable therapeutic option.

Reply to: Observation on the article “Long‐term follow‐up comparison of two different bilayer dermal substitutes in tissue regeneration: Clinical outcomes and histological findings”

“…For this reason, we add to the clinical outcome the histological and immunohistochemical evaluation, which showed the good quality of the newly formed regenerated tissue. The fastest angiogenesis may occur due to increased M2 polarisation, which is more angiogenic than M1, 13,14 as observed from Uccioli et al [11][12][13][14][15] Histological and immunohistochemical data obtained on traumatic lesion after Nevelia implants are comparable to the ones observed from our group in venous and arterial chronic ulcers treatment on 35 patients showing a regenerated skin architecture analogue to normal skin physiology. 16 Nevelia has a very limited number of studies [15][16][17][18][19][20] so far.…”

The Immune-Centric Revolution in the Diabetic Foot: Monocytes and Lymphocytes Role in Wound Healing and Tissue Regeneration—A Narrative Review

“…Moreover, after 6 months, 6 patients (60%) of the Nevelia ® completely healed, while only 1 patient (20%) healed in the control group, suggesting that this dermal substitute induce tissue reparative processes through macrophage activation and M2 reparative polarization in diabetic lesions [158]. The positive clinical outcome of this dermal substitute was previously observed by the sane authors in 41 patients with chronic diabetic wound [159]. In addition, Nevelia ® dermal substitute was observed to polarize in M2 and also in an in vitro model [160].…”

“…No glycosaminoglycan (GAG) added to improve cell attachment and proliferation. Glutaraldehyde Cross-linking [157][158][159] Integra Bilayer system for skin replacement made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The Integra pore size of 20 to 125 µm allows influx of cells.…”

Trichoderma longibrachiatum and Aspergillus fischeri Infection as a Cause of Skin Graft Failure in a Patient with Critical Burns after Liver Transplantation

“…Nevelia ® (Symatese Aesthetic, Chaponost, France) is a relatively new bi-layered dermal substitute. It consists of a three-dimensional porous matrix of Type I bovine collagen covered by a silicone layer reinforced with polyester, which represents pseudo-epidermis [ 9 ]. The pore size in the collagen matrix is optimized to approx.…”