Haemostatic efficacy and inflammatory response of a novel beta-chitin patch in a cerebral small vessel injury model - A pilot study.

OBJECTIVE: Rapid and efficacious haemostasis is paramount in neurosurgery. Assessing the efficacy and short- and long-term safety of haemostatic agents utilised within cerebral tissue is essential. This pilot study investigates the haemostatic efficacy and long-term safety of a novel beta-chitin patch against traditionally used agents, bipolar and Floseal, within cerebral tissue. METHODS: Eighteen Merino sheep underwent standardised distal cortical vessel injury via temporal craniotomy. Sheep were randomised to receive 2 mls Floseal, 2 cm novel beta-chitin patch, or bipolar cautery to manage bleeding. All sheep underwent cerebral magnetic resonance imaging (MRI) at three months, before euthanasia and brain harvesting for histological assessment. RESULTS: Beta-chitin demonstrated a trend towards a faster mean time to haemostasis (TTH) compared to Floseal (223.3 ± 199 s v. 259.8 ± 186.4 s), albeit non-significant (p = 0.234). Radiologically, cerebrocortical necrosis (p = 0.842) and oedema (p = 0.368) were noted slightly more frequently in the beta-chitin group. Histologically, severe fibrotic (p = 0.017) and granulomatous changes at the craniotomy sites were only present in the beta-chitin group (p = 0.002). Neuronal degeneration was seen in all with Floseal, but beta-chitin showed a trend towards more severe reaction when present. Bipolar use predominantly showed an inflammatory cortical reaction with substantial microvascular proliferation, and Floseal showed worse severity and depth of subpial oedema, however no statistical significance was reached. CONCLUSION: All haemostats controlled bleeding, with beta-chitin demonstrating a non-inferior TTH compared to Floseal. However, it resulted in intense granulomatous and fibrotic changes, including degenerative neuronal reactions. More extensive studies are needed to assess these trends, to make further clinical inferences.

Local and systemic metal ion release occurs intraoperatively during correction and instrumented spinal fusion for scoliosis.

STUDY DESIGN: Prospective pilot study. OBJECTIVES: The aim of this study was to measure titanium, niobium and aluminium levels in various intraoperative and postoperative samples to determine patterns of metal ion release that occur within the first month following instrumented spinal fusion. Raised serum metal ion levels are reported following instrumented spinal fusion in adolescent idiopathic scoliosis. The exact topological origin and chronology of metal ion release remains conjectural. Recent literature suggests an immediate rise in serum metal levels within the first postoperative week. METHODS: Titanium, niobium and aluminium levels were measured before, during and after surgery in serum and local intraoperative fluid samples obtained from two pediatric patients undergoing posterior correction and instrumentation for scoliosis. RESULTS: Measurable metal ion levels were detected in all local samples obtained from wound irrigation fluid, cell saver blood, and fluid that immersed metal universal reduction screw tabs. Postoperative serum metal ion levels were elevated compared to baseline preoperative levels. In general, metal ion levels were considerably higher in the intraoperative fluid samples compared to those observed in the serum levels. CONCLUSION: Our findings of contextually high metal ion concentrations in intraoperative and early postoperative samples provide further empirical support of a 'putting-in' phenomenon of metal ion release following instrumented spinal fusion. This challenges existing beliefs that metal ion release occurs during an intermediate 'wearing-in' phase. We recommend thorough irrigation of the operative site prior to wound closure to dilute and remove intraoperative metal ion debris. Possibilities of filtering trace metal ions from cell saver content may be considered.