Department of Surgery, RadboudUMC, Nijmegen, The Netherlands.
GATT Technologies BV, Nijmegen, The Netherlands.
J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18.
A new cost-effective NHS functionalized polyoxazoline (POx) loaded polymer with strong hemostatic properties has been developed. In this study, we investigate POx loaded hemostatic patches regarding hemostatic efficacy, local inflammatory reaction and wound-healing, as compared to the non-POx treated blanks and commercially available hemostatic products. Hundred and ten rats divided into 11 groups of 10 animals underwent partial liver lobe resection. Eight groups received experimental patches, two groups commercially available hemostatic patches (TachoSil® and Veriset™, positive controls), one group with gauzes (negative control). Each animal received twice a patch with a size 1.5 × 2.5 cm, on each partially resected lobe. Primary endpoint was time to hemostasis (TTH). The rats were sacrificed at different time points (1, 3, or 7 days) to measure local inflammatory response and early wound healing. Of the POx loaded patches, GFC NHS-POx (TTH 20.4 s, p = .019) and GFC-NHS-POx1.5 (TTH 0.0 s, p = .003) showed significantly faster TTH compared to TachoSil® (TTH 95.4 s), and were comparable to Veriset™ (TTH 17.0 s). Three patches, GFC-NHS-POx 1.5 (TTH 0.0 s, p = .016), ORC NHS-POx:NU-POx (TTH 91.4 s, p = .033), and ORC-PLGA NHS-POx:NU-POx (TTH 105.6 s, p = .04) had a lower TTH compared to their own blank carrier (TTH 74.9, 157.8, and 195.7 s, respectively). With regard to biocompatibility, all POx loaded patches showed results comparable to TachoSil® and Veriset™. NHS-POx-loaded hemostatic patch demonstrate fast and effective hemostasis, comparable or better than commercially available hemostatic patches, with similar early biocompatibility.
一种新的具有成本效益的 NHS 功能化聚恶唑啉(POx)负载聚合物,具有强大的止血性能。在这项研究中,我们研究了 POx 负载的止血贴片在止血效果、局部炎症反应和伤口愈合方面的情况,与未处理的 POx 空白对照和市售止血产品进行了比较。
110 只大鼠分为 11 组,每组 10 只,进行部分肝叶切除术。8 组接受实验性贴片,2 组接受市售止血贴片(TachoSil®和 Veriset™,阳性对照),1 组接受纱布(阴性对照)。每个动物在每个部分切除的肝叶上各接受大小为 1.5×2.5cm 的贴片两次。主要终点是止血时间(TTH)。在不同时间点(1、3 或 7 天)处死大鼠,以测量局部炎症反应和早期伤口愈合。
在 POx 负载的贴片中,GFC NHS-POx(TTH 20.4s,p=0.019)和 GFC-NHS-POx1.5(TTH 0.0s,p=0.003)与 TachoSil®(TTH 95.4s)相比,TTH 明显更快,与 Veriset™(TTH 17.0s)相当。
三种贴片,GFC-NHS-POx 1.5(TTH 0.0s,p=0.016)、ORC NHS-POx:NU-POx(TTH 91.4s,p=0.033)和 ORC-PLGA NHS-POx:NU-POx(TTH 105.6s,p=0.04)与各自的空白载体相比,TTH 更低(分别为 74.9、157.8 和 195.7s)。
就生物相容性而言,所有负载 POx 的贴片的结果与 TachoSil®和 Veriset™相似。NHS 负载的 POx 止血贴片具有快速有效的止血效果,与市售止血贴片相当或更好,早期生物相容性相似。