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Hemopatch® 与 Surgicel® Original 控制轻度和中度肝出血的效果比较。

Effectiveness of Hemopatch® versus Surgicel® Original to control mild and moderate liver bleeding.

机构信息

Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria.

Section for Surgical Research, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.

出版信息

BMC Surg. 2022 Aug 14;22(1):316. doi: 10.1186/s12893-022-01747-0.

DOI:10.1186/s12893-022-01747-0
PMID:35965336
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9375927/
Abstract

BACKGROUND

Adjunct hemostats can be of use in certain surgical settings. We compared the effectiveness of two hemostats, Hemopatch® and Surgicel® Original in controlling bleeding from liver lesions in an experimental model.

METHODS

Control of grades 1 (mild) and 2 (moderate) bleeding (according to the Validated Intraoperative Bleeding [VIBe] SCALE) was assessed for 10 min after Hemopatch® (n = 198) or Surgicel® Original (n = 199) application on 397 liver surface lesions. The primary endpoint was hemostatic success (reaching VIBe SCALE grade 0 at 10 min). The secondary endpoint was time to hemostasis (time to reach and maintain grade 0). A generalized linear mixed model and an accelerated failure time model were used to assess the primary and secondary endpoints, respectively.

RESULTS

The overall hemostatic success rate of Hemopatch® was statistically significantly superior to that of Surgicel® Original (83.8% versus 73.4%; p = 0.0036; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.33-4.27) and time to hemostasis was reduced by 15.9% (p = 0.0032; 95% CI 0.749-0.944). Grade 2 bleeds treated with Hemopatch® had statistically significantly higher hemostatic success (71.7% versus 48.5%; p = 0.0007; OR 2.97, 95% CI 1.58-5.58) and shorter time to hemostasis (49.6% reduction, p = 3.6 × 10); differences for grade 1 bleeds (hemostatic success rate or time to hemostasis) were not statistically significant.

CONCLUSIONS

Hemopatch® provided better control of VIBe SCALE bleeding compared to Surgicel® Original for Grade 2 bleeds in this porcine model, highlighting the importance of choosing a suitable hemostat to optimize control of bleeding during surgery.

摘要

背景

辅助止血剂在某些手术环境中可能有用。我们比较了两种止血剂 Hemopatch® 和 Surgicel® Original 在控制猪肝损伤出血方面的效果。

方法

在 397 个肝表面损伤处,评估 198 例 Hemopatch®和 199 例 Surgicel® Original 应用后 10 分钟内控制 1 级(轻度)和 2 级(中度)出血(根据经验证的术中出血[VIBe] SCALE 评估)。主要终点是止血成功(10 分钟时达到 VIBe SCALE 0 级)。次要终点是止血时间(达到和维持 0 级的时间)。采用广义线性混合模型和加速失效时间模型分别评估主要和次要终点。

结果

Hemopatch®的总体止血成功率明显优于 Surgicel® Original(83.8%比 73.4%;p=0.0036;优势比[OR]2.38,95%置信区间[CI]1.33-4.27),止血时间缩短了 15.9%(p=0.0032;95%CI0.749-0.944)。Hemopatch®治疗的 2 级出血止血成功率明显更高(71.7%比 48.5%;p=0.0007;OR2.97,95%CI1.58-5.58),止血时间更短(缩短 49.6%,p=3.6×10);1 级出血的止血成功率或止血时间差异无统计学意义。

结论

在该猪模型中,与 Surgicel® Original 相比,Hemopatch®在 2 级出血中能更好地控制 VIBe SCALE 出血,强调在手术中选择合适的止血剂以优化出血控制的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c6/9375927/decb3d8d6643/12893_2022_1747_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c6/9375927/d6909636bbe9/12893_2022_1747_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c6/9375927/decb3d8d6643/12893_2022_1747_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c6/9375927/d6909636bbe9/12893_2022_1747_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99c6/9375927/decb3d8d6643/12893_2022_1747_Fig2_HTML.jpg

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