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Use of Hyaluronate-Alginate Gel-coated Small Intestine Submucosa for Nerve Protection in a Preclinical Adhesion Model
Nesreen Zoghoul Alsmadi, PhD
1; Curt Deister, PhD
2; Peter Evans, MD, PhD
3; Tamer Ghanem, MD, PhD
4; Brandon S. Smetana, MD
5; Deana M. Mercer, MD
61Axogen, Alachua, FL; 2Clinical and Translational Sciences, AxoGen Inc, Alachua, FL; 3Hand & Upper Extremity Surgery, Cleveland Clinic, Cleveland, OH; 4Premier Head and Neck Surgery, Flint, MI; 5Indiana Hand to Shoulder Center, Indianapolis, IN; 6The University of New Mexico, Albuquerque, NM
IntroductionThis study evaluated the use of a hyaluronate-alginate gel-coated small intestine submucosa (HA-SIS) wrap to protect an intact non-traumatized nerve in a disrupted wound bed. We hypothesized that using HA-SIS wrap may reduce adhesion formation, decrease scarring within the nerve, and improve vascularity compared to an unwrapped nerve in a similar wound environment.
Materials & Methods60 rats were divided into three groups (Table 1). The sciatic nerve was isolated. In two groups, the muscle surrounding the nerve was disrupted by cauterization using a 3D printed guide to maintain size and location consistency. In the HA-SIS group, the nerve was wrapped in Axoguard HA+™ (Axogen Corp., Alachua, FL). The contralateral leg served as a control.
Animals from each group were randomized into 6 or 26-week explantation groups of 10. Samples were analyzed utilizing gross pathology and histology.
ResultsGastrocnemius muscle wet weight was significantly higher in the HA-SIS group than in the untreated injury and sham groups at 26 weeks, p=0.008 and p=0.04, respectively. At both timepoints, a translucent connective tissue consistent with scar tissue formation was noted around the nerve of all samples explanted from the surgical leg. At 6 weeks, adhesion scores of the untreated injury and HA-SIS groups were significantly higher than the sham, p<0.001 and p = 0.03, respectively. At 26 weeks, the adhesion score trended higher in the untreated injury group than the HA-SIS and was significantly higher in the untreated injury group than the sham group, p < 0.001. At 6 and 26 weeks, extraneural collagen deposition was significantly higher in the untreated injury group than the sham and the HA-SIS, p=0.02 and p<0.001, respectively for both timepoints. CD68-positive macrophages were similar across groups at 6 weeks explant. At 26 weeks, CD68-positive macrophages in the untreated injury group were significantly higher than the HA-SIS group, p = 0.01. No differences were noted across groups for intraneural collagen-to-cell ratio and blood vessels numbers.
ConclusionsThe results show that using HA-SIS as a nerve wrap in an injured muscle bed results in less functional deficit, less adhesion, less extraneural collagen deposition, and fewer CD68-positive macrophages as compared to an unwrapped nerve. Nerves receiving HA-SIS showed equivalent vascularization as a sham procedure.
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