Fibrin Tissue Adhesive

纤维蛋白组织粘连
  • 文章类型: Journal Article
    长骨不愈合是骨折治疗中的一个共同挑战。骨移植通常用于治疗萎缩性骨不连,但是移植物可能会发生机械移位,导致治疗延误或失败。纤维蛋白胶在神经外科和口腔颌面外科的骨缺损治疗中显示出积极的结果。然而,关于其在长骨骨折中的应用还没有任何研究。
    我们在一个三级中心进行了一项前瞻性随机对照试验,涉及长骨骨折不愈合且仅需要植骨的成年患者。自体髂骨骨移植到清创不愈合部位,与额外的纤维蛋白胶应用于干预臂。对患者进行连续X光片随访,直到临床和影像学结合。
    10名患者(3名男性,7女),平均年龄41.7(19-63)的人被招募了五年,一个人退出。9个骨折中有8个在治疗后合并。一名患者经历了肥厚性不连,需要重新固定和植骨。纤维蛋白胶组(19.5周)与对照组(18.75周)的患者愈合时间没有差异(p=0.86)。使用纤维蛋白胶没有并发症。
    纤维蛋白胶似乎是治疗不同骨折部位的长骨骨折不愈合的安全辅助手段,尽管没有显示更快的愈合时间。
    UNASSIGNED: Non-union of long bones is a common challenge in the treatment of fractures. Bone grafting is commonly used to treat atrophic non-union, but mechanical displacement of the graft may occur, resulting in delay or failure of treatment. Fibrin glue has demonstrated positive results in management of bone defects in neurosurgery and oromaxillary facial surgery, however, there has yet to be any study on its use in long bone fractures.
    UNASSIGNED: We conducted a prospective randomised controlled trial at a single tertiary centre involving adult patients with long bone fractures that had undergone non-union and requiring bone grafting only. Autologous iliac crest bone graft was applied to the debrided non-union site, with additional fibrin glue applied for the intervention arm. Patients were followed-up with serial radiographs until clinical and radiographical union.
    UNASSIGNED: Ten patients (3 male, 7 female), of mean age 41.7 (19 - 63) were recruited over five years, with one drop out. Eight out of nine fractures united after treatment. One patient underwent hypertrophic non-union requiring re-fixation and bone grafting. There was no difference in the time to union for patients in the fibrin glue group (19.5 weeks) versus the control group (18.75 weeks) (p=0.86). There were no complications sustained from usage of fibrin glue.
    UNASSIGNED: Fibrin glue appears to be a safe adjunct for treatment of non-union of long bone fractures across varying fracture sites by holding the bone graft in place despite not demonstrating a faster time to union.
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  • 文章类型: Journal Article
    血友病患者经常需要补充干预措施,要么是侵入性的(缝合,凝胶泡沫,或烧灼)或非侵入性(纤维蛋白密封剂/胶水),在牙科手术后实现止血。这项研究旨在比较纤维蛋白密封剂与传统方法在牙科手术后实现止血的功效。因子VIII或IX缺乏症患者的医疗记录,或者vonWillebrand病,他在牙科部门接受了牙科手术,SethGSMC和KEM医院,在这项回顾性配对队列研究中进行了纳入评估。队列1包括使用纤维蛋白密封剂(TisseelLyo)治疗的患者,术后有/没有传统的止血措施,而队列2(对照)包括未使用纤维蛋白密封剂的患者。共有128名患者,每组64人,进行了评估。人口统计学差异无统计学意义,疾病相关变量,牙科投诉,或组间给予术前治疗。然而,止血的二次手术(缝合,凝胶泡沫应用,和/或烧灼)和与对照组相比,纤维蛋白胶组的术后因素置换需求(P=0.003)。在这项研究中,纤维蛋白密封剂在减轻主动止血控制的必要性方面表现出优异的功效。
    Patients with hemophilia frequently require supplementary interventions, either invasive (suturing, gel foam, or cauterization) or non-invasive (fibrin sealant/glue), to attain hemostasis post dental procedures. This study aimed to compare the efficacy of fibrin sealant against traditional methods for achieving hemostasis post dental surgery. The medical records of patients with factor VIII or IX deficiency, or von Willebrand disease, who underwent dental procedures in the Department of Dentistry, Seth GSMC and KEM Hospital, were evaluated for inclusion in this retrospective matched cohort study. Cohort-1 included those treated with a fibrin sealant (Tisseel Lyo) with/without traditional hemostatic measures post-procedure, while cohort-2 (controls) included those in whom no fibrin sealant was used. A total of 128 patients, 64 in each group, were evaluated. There was no statistically significant difference in demographics, disease-related variables, dental complaints, or preoperative treatment given between the groups. However, there was a significant reduction (P < 0.001) in the requirement for secondary procedures for hemostasis (suturing, gel foam application, and/or cauterization) and postoperative requirement for factor replacement (P = 0.003) in the fibrin glue group as compared to the controls. In this study, fibrin sealant demonstrated superior efficacy in mitigating the necessity for active hemostasis control.
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  • 文章类型: Journal Article
    早期三阴性乳腺癌术后局部复发是一项重大挑战。为了控制残留肿瘤的再生长,我们开发了一种用于术中植入的自体治疗混合纤维蛋白胶。使用自体血清蛋白作为稳定剂,我们优化了高载药量拉帕替尼-纳米血清(Lap-NS;~66%L.C.)和咪喹莫特-微血清(IMQ-MS;~92%L.C.)。此外,还开发了在980nm激光照射下具有67%光热转换效率的等离子体纳米血清(PNS)。虽然Lap-NS或PNS的局部单一疗法降低了肿瘤的再生长速率,它们与IMQ-MS的组合放大了免疫原性细胞死亡的影响,并在手术部位通过免疫细胞进行高水平的肿瘤浸润。具有基于Nano-MicroSera的杂合纤维蛋白植入物的局部组合免疫疗法显示出优异的肿瘤抑制和存活,具有用于临床转化的显著希望。
    Local recurrence post-surgery in early-stage triple-negative breast cancer is a major challenge. To control the regrowth of a residual tumor, we have developed an autologous therapeutic hybrid fibrin glue for intra-operative implantation. Using autologous serum proteins as stabilizers, we have optimized high drug-loaded lapatinib-NanoSera (Lap-NS; ∼66% L.C.) and imiquimod-MicroSera (IMQ-MS; ∼92% L.C). Additionally, plasmonic nanosera (PNS) with an ∼67% photothermal conversion efficiency under 980 nm laser irradiation was also developed. While localized monotherapy with either Lap-NS or PNS reduced the tumor regrowth rate, their combination with IMQ-MS amplified the effect of immunogenic cell death with a high level of tumor infiltration by immune cells at the surgical site. The localized combination immunotherapy with a Nano-MicroSera based hybrid fibrin implant showed superior tumor inhibition and survival with significant promise for clinical translation.
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  • 文章类型: Journal Article
    目的:评价应用纤维蛋白胶(FG)对翼状胬肉手术患者局部应用环孢素A(CsA)0.05%的疗效。
    方法:对原发性鼻状翼状胬肉患者进行回顾性分析,分为两组:第1组38例41只眼作为对照组,第2组39只眼来自36例接受CsA治疗的患者,每天两次,持续6个月。评估患者的复发率,泪膜参数,副作用,术后1-7天的并发症;第1,3rd,第6个月和第12个月。随访期为1年。
    结果:两组年龄(p=0.934)和性别(p=0.996)匹配。1周后,由于烧灼感和结膜充血,一名患者停止了CsA滴剂。第1组的术前和术后第1年的平均SchirmerI和泪液破裂时间(TBUT)值之间没有统计学上的显着差异(p=0.136;p=0.069)。尽管第2组的术前和术后第1年TBUT平均值之间的差异无统计学意义(p=0.249),SchirmerI结果术后较高(p=0.003)。术前Schirmer之间无统计学差异(p=0.496),术后Schirmer(p=0.661),术前TBUT(p=0.240)和术后TBUT(p=0.238)结果比较。仅在第1组的一名患者中观察到复发。
    结论:第2组无复发性翼状胬肉病例。第2组术后SchirmerI值较高;因此,外用CsA治疗可改善泪腺分泌,并在翼状胬肉手术后有效。
    OBJECTIVE: To evaluate the effect of topical cyclosporine A (CsA) 0.05% in patients with pterygium surgery using fibrin glue (FG).
    METHODS: Patients with primary nasal pterygium were retrospectically analyzed and categorized into two groups: Group 1 with 41 eyes from 38 patients as a control group and group 2 with 39 eyes from 36 patients who received topical CsA twice a day for 6 months. Patients were assessed for recurrence rate, tear film parameters, side effects, and complications at postoperative intervals of 1-7 days; 1st, 3rd, 6th and 12th months. The follow-up period was 1 year.
    RESULTS: The two groups were age (p = 0.934) and sex (p = 0.996) matched. CsA drop was discontinued in one patient due to burning sensation and conjunctival hyperemia after 1 week. There was no statistically significant difference between the mean preoperative and postoperative 1st year Schirmer I and tear break-up time (TBUT) values in group 1 (p = 0.136; p = 0.069). Although the difference between the mean preoperative and postoperative 1st year TBUT values in group 2 was not statistically different (p = 0.249), Schirmer I results were higher postoperatively (p = 0.003). There was no statistically significant difference between preoperative Schirmer (p = 0.496), postoperative Schirmer (p = 0.661), preoperative TBUT (p = 0.240) and postoperative TBUT (p = 0.238) results of the two groups. Recurrence was observed in only one patient from group 1.
    CONCLUSIONS: No recurrent pterygium cases were observed in group 2. Schirmer I values were higher postoperatively in group 2; thus,topical CsA treatment may improve lacrimal secretion and be effective after pterygium surgery with FG.
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  • 文章类型: Case Reports
    背景:牙周和牙髓联合病变的成功取决于消除这两种疾病过程。在合并内围手术期病变的情况下,牙髓治疗导致参与的牙髓成分愈合,而牙齿的预后最终取决于牙周结构的愈合。
    方法:本病例报告评估自体纤维蛋白胶和植骨的疗效,也就是说,粘骨在治疗与子宫内膜病变相关的骨缺损中的应用。内周病变首先进行牙髓治疗,其次是牙周治疗。结论:患者随访9个月,在骨填充和口袋深度减少方面获得了令人满意的结果。
    在治疗围手术期病变时,粘骨可增强再生。
    BACKGROUND: The success of a combined periodontal and endodontic lesion depends on the elimination of both these disease processes. In the case of a combined endo-perio lesion, endodontic therapy results in healing of the endodontic component of involvement, while the prognosis of teeth would finally depend on the healing of the periodontal structure.
    METHODS: This case report evaluates the efficacy of autologous fibrin glue and bone graft, that is, sticky bone in the management of bone defects associated with endo-perio lesion. The endo-perio lesion is first treated endodontically, followed by periodontal therapy. Conclusion: The patient was kept on follow-up for 9 months, and satisfactory results in terms of bone fill and reduction in pocket depth were obtained.
    UNASSIGNED: The sticky bone enhances regeneration in treatment of endo-perio lesions.
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  • 文章类型: Journal Article
    与平头钉和缝线相比,使用纤维蛋白胶进行腹股沟疝网片固定术已被认为可有效预防血肿并减轻术后疼痛。.纤维蛋白胶的作用可基于所使用的装置而显著变化。这项研究根据离体系统中使用的设备类型评估了纤维蛋白胶的功效。将兔子的腹壁修剪成3.0×6.0cm的尺寸,并用金属固定装置固定在边缘处。要测量粘合破坏点处的最大拉伸强度,用纤维蛋白胶将疝网片固定在2厘米见方的兔腹壁上,离开3分钟,然后以50cm/min的速度拉动。每组进行10次测试。使用喷涂的中值(最小-最大)抗拉强度值,双液混合,顺序分层方法为3.58(1.99-4.95),0.51(0.27-1.89),和1.32(0.63-1.66)N,分别。与双液混合和顺序分层方法相比,喷涂方法具有更高的拉伸强度值(P<0.01)。总之,在疝网片固定术中,可以采用喷涂方法来达到适当的粘合效果。
    The use of fibrin glue for inguinal hernia mesh fixation has been suggested to be effective in preventing hematomas and reducing postoperative pain compared to tacks and sutures.. The effect of fibrin glue can vary significantly based on the device used. This study assessed the efficacy of fibrin glue based on the type of devices used in an ex vivo system. The rabbit\'s abdominal wall was trimmed to a size of 3.0 × 6.0 cm and was secured at the edges with metal fixtures. To measure the maximum tensile strength at the point of adhesion failure, the hernia mesh was fixed to the rabbit\'s abdominal wall using fibrin glue in a 2 cm square area, left for 3 min, and then pulled at a speed of 50 cm/min. The test was conducted 10 times for each group. The median (minimum-maximum) tensile strength values using the spraying, two-liquid mixing, and sequential layering methods were 3.58 (1.99-4.95), 0.51 (0.27-1.89), and 1.32 (0.63-1.66) N, respectively. The spraying method had predominantly higher tensile strength values than the two-liquid mixing and sequential layering methods (P < 0.01). In conclusion, in hernia mesh fixation, the spraying method can be adopted to achieve appropriate adhesive effects.
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  • 文章类型: Journal Article
    生物粘附材料和贴片是有希望的外科缝合线和U形钉的替代品。然而,许多现有的生物粘合剂不满足当前外科手术和干预的功能要求。这里,我们提出了一种平移贴片材料,它表现出对组织的即时粘附力(比蒂塞尔强2.5倍,FDA批准的纤维蛋白胶),超拉伸性(拉伸至原始长度的300%而不失去弹性),与快速照片投影的兼容性(<2分钟制造时间/补丁),和提供治疗的能力。使用我们建立的各向异性拉胀贴片的计算机设计和优化程序,我们创造了下一代贴剂,用于即时附着到组织上,同时符合广泛的离体和体内器官力学。用源自间充质干细胞的细胞外囊泡涂覆的贴片在体内表现出强大的伤口愈合能力,而不诱导异物反应,并且不需要可引起疼痛和出血的贴片去除。我们进一步展示了一种基于单一材料的,设计用于治疗肺穿刺伤口的空隙填充拉胀补片。
    Bioadhesive materials and patches are promising alternatives to surgical sutures and staples. However, many existing bioadhesives do not meet the functional requirements of current surgical procedures and interventions. Here, we present a translational patch material that exhibits instant adhesion to tissues (2.5-fold stronger than Tisseel, an FDA-approved fibrin glue), ultra-stretchability (stretching to >300% its original length without losing elasticity), compatibility with rapid photo-projection (<2 min fabrication time/patch), and ability to deliver therapeutics. Using our established procedures for the in silico design and optimization of anisotropic-auxetic patches, we created next-generation patches for instant attachment to tissues while conforming to a broad range of organ mechanics ex vivo and in vivo. Patches coated with extracellular vesicles derived from mesenchymal stem cells demonstrate robust wound healing capability in vivo without inducing a foreign body response and without the need for patch removal that can cause pain and bleeding. We further demonstrate a single material-based, void-filling auxetic patch designed for the treatment of lung puncture wounds.
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  • 文章类型: Journal Article
    The article presents literature and our own data on surgical treatment and options for solving the problem of restenosis for congenital choanal atresia in children under one year of age. A new stentless choanoplasty technique using fibrin glue for fixation of posterior septal flaps is presented. This method has patent No. 2789967 dated February 14, 2023.
    OBJECTIVE: Evaluation of the effectiveness of the choanoplasty method using fibrin glue for fixation of flaps without the use of a stent in children of the first year of life with choanal atresia.
    METHODS: For the period from 2019 to 2023, a team of authors in the Department of Otorhinolaryngology of the Veltishchev Research Clinical Institute of Pediatrics and Pediatric Surgery operated on 34 patients under the age of one year with a diagnosis of choanal atresia using this choanoplasty technique.
    RESULTS: The results of this new surgical technique using fibrin glue are presented. Endoscopy of the nasal cavity and choanal area in all 34 patients during follow-up (from 1 to 2 years) showed no signs of restenosis.
    CONCLUSIONS: The proposed method of choanoplasty without the use of stents with fixation of mucosal flaps with fibrin glue has proven itself well and can be used in children at any age, can be one of the ways to solve the problem of restenosis and seems to us to be the method of choice in the treatment of choanal atresia.
    В статье приведены данные литературы и собственные данные о хирургическом лечении и вариантах решения проблемы рестенозирования при врожденной атрезии хоан у детей на первом году жизни. Представлен новый метод хоанопластики, позволяющий не использовать стенты и тампонаду в послеоперационном периоде. Предложенный способ основан на применении фибринового клея для фиксации задних септальных лоскутов (патент РФ №RU 2789967 C1 от 14.02.23).
    UNASSIGNED: Оценить эффективность эндоскопического транссептального метода хоанопластики с формированием задних септальных лоскутов и фиксацией их медицинским фибриновым клеем у детей первого года жизни с атрезией хоан.
    UNASSIGNED: За период с 2019 по 2023 г. коллективом авторов в отделении оториноларингологии ОСП «Научно-исследовательский клинический институт педиатрии и детской хирургии им. акад. Ю.Е. Вельтищева ФГБОУ ВО «РНИМУ им. Н.И. Пирогова» Минздрава России прооперированы 34 пациента в возрасте от 14 дней жизни до 1 года с диагнозом «врожденная атрезия хоан» с применением данного метода хоанопластики.
    UNASSIGNED: В процессе катамнестического наблюдения (1—2 года) при эндоскопическом исследовании полости носа и носоглотки у всех 34 пациентов признаки рестенозирования не обнаружены.
    UNASSIGNED: Предложенный метод хоанопластики впервые в Росийской Федерации позволил достичь клинического эффекта у грудных детей без применения стентов, что в значительной мере улучшает качество жизни ребенка в раннем послеоперационном периоде, позволяет избежать необходимости трахеостомии, продленной искусственной вентиляции легких и зондового питания. Новый перспективный вариант решения проблемы рестенозирования представляется нам методом выбора при лечении врожденной атрезии хоан.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    目的:脑脊液(CSF)泄漏是硬膜内颅手术的一个有挑战性的并发症,儿童尤其处于危险之中。硬脑膜密封剂的使用赋予成人保护,但是儿科研究很少。我们评估了Evicel®纤维蛋白密封剂作为头颅手术儿童原发性硬膜缝合的辅助手段的安全性和有效性。
    方法:一项多中心试验前瞻性招募接受颅神经外科手术的儿科受试者(<18岁),完成一期硬脑膜缝合修复后,有脑脊液渗漏。根据EMAEvicel®儿科调查计划的同意,40名受试者在术中2:1随机分配至Evicel®或其他缝线(“缝线”)。数据分析是描述性的。疗效终点为治疗成功率,成功定义为挑衅性Valsalva动作后的术中水密闭合(主要终点)。安全终点为术后脑脊液漏(切口脑脊液漏,假性脑膜膨出或两者兼有)和手术部位并发症(次要终点)。
    结果:40名受试者(0.6-17岁)被随机分为Evicel®(N=25)或Sutures(N=15)(意向治疗)。颅内肿瘤是最常见的适应症,手术多为幕上开颅手术。Evicel®的成功率为92.0%,缝线为33.3%,估计成功率为2.76(Farrington-Manning95%CI[1.53,6.16])。每个方案和安全性集中的敏感性分析显示出类似的结果。尽管抢救治疗率较高,与Evicel®相比,缝线术后脑脊液漏和伤口并发症的发生率更高.
    结论:这项小规模前瞻性研究表明,在儿科人群中,Evicel®治疗作为原发性缝合硬脑膜闭合的辅助治疗是安全有效的。与额外的缝线相比,Evicel®与术后脑脊液漏和手术部位并发症减少有关。(试验登记:试验登记为NCT02309645和EudraCT2013-003558-26)。
    OBJECTIVE: Cerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.
    METHODS: A multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel® or additional sutures (\'Sutures\'). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints).
    RESULTS: Forty subjects (0.6-17 years) were randomized to Evicel® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel®.
    CONCLUSIONS: This small-scale prospective study shows Evicel® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).
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