Objective To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
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Objective Multilevel or revisional posterior spinal surgery is prone to infection and delayed wound healing, related with the wound closure time and suture strength. Knotless barbed suture is an innovative self-locking, multianchor suture. This study aims to evaluate the safety and efficacy of the knotless barbed suture and self-adhering mesh with polymeric glue in multilevel or revisional posterior spinal surgery.
Methods This is a single-center retrospective matched cohort study. Patients were divided into 2 groups based on the wound closure method: barbed suture group with novel wound closure, and conventional suture group with conventional wound closure, 1:1 matched by the level of surgery and sex, resulting in 120 subjects each. Total operation time and wound closure time were measured intraoperatively, and perioperative clinical outcome parameters including postoperative wound complication were investigated for the first 3 months postoperatively. The distribution of continuous variables was assessed for normality by Shapiro-Wilk test, then parametric or nonparametric tests were applied accordingly (paired t-test or Wilcoxon signed-rank test).
Results Wound closure time was significantly shorter with the novel barbed suture than with conventional suture in all subgroups divided by the level of spinal surgery: 3–5, 6–9, ≥ 10 levels (p < 0.001). The 2 groups showed no significant differences in surgical complications (p = 1.000). Specially, total operation time and wound-closing time were significantly shorter in revisional subgroup.
Conclusion Absorbable knotless barbed suture and self-adhering mesh with polymeric glue can shorten spinal wound closure time with noninferiority in complications for multilevel or revisional spinal surgery.
Citations
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