胶原海绵止血功能的实验研究

目的 验证国产胶原海绵的止血性能。方法 选用健康成年SD大鼠20只,随机分为二组,行肝脏和切口,分别用胶原及明胶少绵止血,观察止血情况;切除肝左前叶造成标准肝创伤模型,分别用二种海绵止血,观察止血情况,并记录即时止血时间及出血量。术后7、14及20天剖腹观察腹腔内粘连、腹腔内感染及肝脏愈合情况,并切除部分再生肝组织进行组织学检查。结果 胶原海绵下肝创面粘附良好,即时止因时间及出血量均明显优于对照组（P＜0.05）。组织切片显示胶原海绵吸收、降解快,可诱导肝细胞再生。结论 胶原海绵止血性能良好,能有效导肝再生,吸收降解快,使用方便,有应用、推广价值。     

几丁糖-胶原止血海绵的研制及其生物相容性评价

目的以几丁糖、胶原为主要原料,研制一种新型的创伤止血材料,并对其止血性能及生物相容性进行评价。方法首先制备高纯度的胶原蛋白溶液,使之与几丁糖溶液键合,冷冻干燥成为海绵体。然后进行毒理学检测,包括急性毒性试验、刺激性试验、过敏性试验和溶血性试验。再进行止血及埋植实验:在兔耳部制造1cm×1cm大小的出血创面,包括切断兔耳动脉,在兔肝脏切除1cm×1cm的组织形成渗血创面,分别用几丁糖—胶原海绵、明胶海绵压敷止血,记录止血时间,并把在肝脏止血的海绵缝合进行体内埋植实验。结果几丁糖-胶原海绵在兔耳动脉的平均止血时间为(120±6)s,而明胶海绵为(600±10)s;在兔肝脏的平均止血时间为(45±2)s,而明胶海绵为(75±3)s;体内肝埋植实验的实验组与对照组的结果一样,有轻微的炎性反应,5个月内能在体内完全降解。其余毒理学试验均呈阴性结果。结论几丁糖—胶原海绵具有优良的止血性能及良好的生物相容性。     

皮下腔隙预制粘膜衬里的实验研究

目的：探讨明胶海绵一微粒粘膜移植于皮下腔隙预制粘膜衬里的可行性。方法：将口腔粘膜剪成粘膜微粒,直径〈1mm。实验纽以4：1,8：1,16：1,的面积比例移植,分为Ⅰ组、Ⅱ组和Ⅲ组。将微粒粘膜均匀涂抹于明胶海绵上,然后移植于皮下腔隙,中间以硅胶片分开,防止间隙闭合,关闭切口,对照组不加微粒粘膜。术后1周、2周、3周行大体观察及HE染色,免疫组织化学染色。结果：术后1周可见粘膜散在存活,上皮细胞长入明胶海绵内,各组创面未完全愈合。不同组别之间愈合率有差别。术后二周可见皮下腔隙包膜表面粘膜成活。Ⅰ组、Ⅱ组创面愈合率在80％以上,Ⅰ组、Ⅱ组优于Ⅲ组（P〈0．05）。Ⅰ组、Ⅱ组间差别无统计学意义。术后3周时各实验组创面愈合率均达90％以上,上皮细胞呈极性排列。术后1周时各组明胶海绵均未见明显吸收,3周时仍见部分明胶存留。各实验组在角蛋白抗体免疫组化染色均为阳性,证实为上皮组织。不同组别上皮厚度有差别。结论：微粒粘膜-明胶海绵复合移植在皮下腔隙,可以形成粘膜衬里;微粒粘膜一明胶海绵复合移植在密闭的皮下腔隙后,3周上皮质量最好;复合移植可以增加上皮的厚度,明胶海绵的支架作用可能是上皮层数增多的原因,但是明胶降解较慢,有待寻找降解速率更快的支架材料。     

采用明胶海绵置入法建立大鼠皮肤切口瘢痕模型的实验研究

目的 采用明胶海绵置入皮肤切除型切口的方法增加大鼠皮肤切口的瘢痕宽度.方法 在SD大鼠背部右侧作皮肤全层切除型切口,置入特定规格的无菌明胶海绵,左侧作同等长度线性切口后用镊子夹闭;对照组1的两侧均作切除型切口,伤口内均置入明胶海绵;对照组2两侧也均作切除型切口,但仅在一侧置入明胶海绵.于术后不同时段取材进行各项检测.结果 置入明胶海绵后,伤口或瘢痕宽度为对照侧的4～11倍(P＜0.01),伤口上皮化延迟.对照组1的两侧伤口或瘢痕宽度无差别,同一伤口或瘢痕不同部位宽度一致.对照组2未加明胶海绵侧伤口收缩呈不规则状而非线性.结论 采用明胶海绵置入的方法可以稳定增加大鼠皮肤伤口愈合后的瘢痕宽度,从而为皮肤瘢痕研究提供一种新的动物模型.     

纤维蛋白粘合胶动物实验研究

纤维蛋白粘合胶在小鼠腹腔存留二周;对大鼠肝切口具有可靠的止血作用,对小血管吻合口的粘合效果满意。纤维蛋白粘合胶不引起组织发生病理学变化,不引起豚鼠过敏反应。纤维蛋白粘合胶是一种安全、可靠的止血剂和组织粘合剂,优于凝血酶及明胶海绵。     

医用胶原蛋白海绵治疗重度肝破裂的临床研究

目的：探讨医用胶原蛋白海绵对重度肝破裂创面的治疗作用。方法：将重度肝破裂患者以入院先后为序，随机分成治疗组（68例）和对照组（64例）。治疗组和对照组分别用医用胶原蛋白海绵片和明胶海绵片对肝创面进行止血和填塞。结果：治疗组的止血时间为(19.65±1.28)min，术中出血量为(301.57±56.18)mL均少于对照组［分别为(34.3±1.2)min及(642.3±61.8)mL］(均P<0.05)。治疗组术后腹腔引流量为(380.45±12.34)mL,并发胆瘘(1.5%)及再出血(3.0%)均少于对照组［分别为(693.2±219.4)mL,6.3%及9.5%］(均P<0.05);治疗组术后住院时间(24.01±4.89)d短于对照组(35.8±5.9)d(P<0.05)。术后CT复查显示治疗组创面肝组织修复时间(30.30+6.42)d短于对照组(62.1±7.2)d(P<0.05)。结论：胶原蛋白海绵对肝创面止血效力强于明胶海绵，与创面的黏附力强，术后并发症少，恢复快，是一种治疗肝破裂的有效、安全而可靠的生物材料。     

泰绫联合胶原蛋白海绵在肝切除术中的临床应用

目的 探讨泰绫联合胶原蛋白海绵在肝切除断面的止血、防漏效果。方法 随机将51例择期行肝部分切除术的患者分为治疗组和对照组,治疗组肝断面处理中使用泰绫联合胶原蛋白海绵,对照组不使用任何止血材料,比较两组术后24、48、72 h腹腔引流量、引流管放置时间及创面发生渗血、胆漏的几率。结果 治疗组术后腹腔引流量明显少于对照组,拔管时间缩短,创面渗血、胆漏发生率低于对照组,两组间差异有统计学意义（P＜0.05）。结论 泰绫联合胶原蛋白海绵在肝切除术中具有安全、可靠的止血、防胆漏效果,能显著减少术后腹腔引流量,缩短腹腔引流时间。     

明胶海绵栓塞肝脏穿刺腔道止血的临床研究

目的：研究明胶海绵栓塞肝脏穿刺所致腔道出血的止血效果。方法：对16例经皮肝穿胆道造影引流术（PTCD）患者的穿刺腔道以明胶海绵条栓塞止血。结果：16例实施栓塞者均起到了良好的止血作用。结论：明胶海绵栓塞为肝脏穿刺后有效的止血方法。     

康复新明胶海绵在治疗干槽症中的应用

目的观察康复新明胶海绵治疗干槽症的临床疗效。方法将干槽症患者随机分成两组,实验组应用康复新明胶海绵填塞治疗28例,对照组应用碘仿纱条填塞治疗22例。结果统计学分析显示实验组和对照组疗效差异有统计学意义(P<0.05)。实验组疼痛减轻程度和肉芽生长情况明显优于对照组。结论康复新明胶海绵具有止痛、促进切口愈合的作用,是治疗干槽症较好的方法。     

三种皮肤修复材料对糖尿病大鼠皮肤损伤修复的有效性评价

目的评价胶原蛋白膜、羧甲基壳聚糖止血海绵和明胶生物活性玻璃复合材料对于修复糖尿病大鼠背部皮肤损伤的有效性。方法 SD雄性大鼠腹腔单次注射不同浓度的STZ溶液,并在背部切除不同大小的全层皮肤,以期建立最佳的糖尿病大鼠皮肤损伤模型。三种皮肤修复材料直接贴在损伤处,并用无菌敷料贴覆盖,观察这三种材料对创面恢复情况和伤口愈合速率的影响。结果单次腹腔注射75 mg/Kg的STZ溶液、构建2 cm×2 cm的背部皮肤损伤可建立最佳糖尿病大鼠皮肤损伤模型。胶原和明胶生物玻璃均有一定程度促进该模型皮肤愈合的作用,愈合率与空白对照相比有统计学差异。结论胶原和明胶生物玻璃对糖尿病大鼠的皮肤损伤有治疗作用,羧甲基壳聚糖仅在早期发挥止血作用。     

Combination of a liquid fibrin sealant with sheet‐type hemostatic agents: Experimental evaluation in partial nephrectomy animal model

Liquid fibrin sealants, together with sheet‐type hemostatic agents, have been used during partial nephrectomies to secure effective hemostasis at the suture site. Using animal kidneys, we investigated which hemostatic agent might adhere most effectively to the renal tissue and serve best as a bolster. Liquid fibrin sealant alone, or in combination with a sheet‐type hemostat, such as collagen, gelatin or oxidized‐cellulose hemostat, was applied to the cut surface of the kidney of anesthetized rabbits, and the differences in the degree of adherence to the kidney and resultant hemostatic efficacy were evaluated. Histological analyses were also carried out to compare the degree of adherence of each of the aforementioned hemostats to the kidney tissue. Fibrin sealant plus the collagen or gelatin hemostat was found to have a stronger hemostatic effect than fibrin sealant applied alone or fibrin sealant plus oxidized‐cellulose hemostat. The histological investigation showed that the fibrin sealant adhered well to kidney tissue when it was applied with the collagen or gelatin hemostat, showing the advantage of combining these two materials for achieving effective hemostasis. Fibrin sealant used in combination with the collagen or gelatin hemostat was the most suitable for obtaining a reinforced hemostatic effect at the suture site in a partial nephrectomy animal model.     

防粘连几丁糖膜的制备和部分性能测定

目的制备防粘连几丁糖膜及测定其部分性能.方法在透析后的几丁糖与明胶混合液中加入戊二醛交联后置入冻干机冻干制得几丁糖膜.测定湿润时间、吸水量和吸水率表示其吸水性能.动物实验研究膜的止血性能,观察与创面的粘附情况,记录出血时间,以膜或纱布中Hbo光度吸收值表示出血量.结果几丁糖膜具有良好的吸水性能,适合用于止血.与创面粘附良好,几丁糖膜组、纱布组的出血时间分别为(78.25±6.42)s、(119.05±11.39)s,Hb光度吸收值为0.76±0.51、1.63±0.72,明显优于纱布对照组(P＜0.01).结论几丁糖膜具有一定的止血性能.     

Effective control of hepatic bleeding with a novel collagen-based composite combined with autologous plasma: results of a randomized controlled trial

HYPOTHESIS: A novel collagen-based composite of bovine microfibrillar collagen and bovine thrombin combined with autologous plasma is more effective than standard hemostasis (collagen sponge applied with pressure) in controlling diffuse hepatic bleeding after hemihepatectomy or segmental resection of the liver. DESIGN: Randomized controlled trial. SETTING: Seven university-affiliated medical centers. PATIENTS: Sixty-seven adult patients scheduled for hemihepatectomy or segmental resection who received hemostatic intervention with an investigational treatment (n = 38) or control (n = 29). INTERVENTION: Bleeding hepatic tissue was managed in all control subjects with a collagen sponge with manual pressure. Subjects in the experimental group had the sprayable liquid composite intraoperatively applied to the surgical site. The liquid immediately formed a collagen-fibrin gel that was used without concomitant tamponade. MAIN OUTCOME MEASURES: Hemostatic success was defined as the proportion of subjects in each treatment group who achieved complete hemostasis within 10 minutes. Success rates and median times required to achieve controlled bleeding (ie, slight oozing) and complete hemostasis were compared between treatment groups. RESULTS: All 38 subjects in the experimental group achieved complete hemostasis within 10 minutes compared with only 69% (20/29) of control subjects (P<.001). The median time to controlled bleeding was approximately 4 times longer (250 vs 62 seconds) for control subjects than for experimental group subjects (P<.001). The median time required to achieve complete hemostasis also favored the experimental group (150 vs 360 seconds; P<.001). No adverse events related to the use of the experimental hemostatic agent were detected. CONCLUSIONS: The experimental composite is more effective at controlling and stopping diffuse hepatic bleeding than a collagen sponge applied with pressure; it may be a useful hemostatic agent for patients undergoing hemihepatectomy, segmental resection, and related surgical procedures.     

Effect on hemostasis of an absorbable hemostatic gelatin sponge after transrectal prostate needle biopsy

Objectives

To examine the usefulness of an absorbable hemostatic gelatin sponge for hemostasis after transrectal prostate needle biopsy.

Subjects and Methods

The subjects comprised 278 participants who underwent transrectal prostate needle biopsy. They were randomly allocated to the gelatin sponge insertion group (group A: 148 participants) and to the non-insertion group (group B: 130 participants). In group A, the gelatin sponge was inserted into the rectum immediately after biopsy. A biopsy-induced hemorrhage was defined as a case in which a subject complained of bleeding from the rectum, and excretion of blood clots was confirmed. A blood test was performed before and after biopsy, and a questionnaire survey was given after the biopsy.

Results

Significantly fewer participants in group A required hemostasis after biopsy compared to group B (3 (2.0%) vs. 11 (8.5%), P=0.029). The results of the blood tests and the responses from the questionnaire did not differ significantly between the two groups. In multivariate analysis, only “insertion of a gelatin sponge into the rectum” emerged as a significant predictor of hemostasis.

Conclusion

Insertion of a gelatin sponge into the rectum after transrectal prostate needle biopsy significantly increases hemostasis without increasing patient symptoms, such as pain and a sense of discomfort.     

可吸收止血流体明胶在钩椎关节切除术中的应用

目的探讨可吸收止血流体明胶(Surgiflo~(TM))应用于钩椎关节切除术中的有效性和安全性。方法 2017年1月—2019年5月海军军医大学附属长征医院采用钩椎关节切除术治疗神经根型颈椎病患者126例,术中使用可吸收止血流体明胶止血61例(Surgiflo组),采用明胶海绵止血65例(明胶海绵组)。记录2组术中止血时间、术中出血量、术后1 d和2 d引流量、术后1 d和末次随访日本骨科学会(JOA)评分,以及术后有无过敏、感染等并发症,综合评价2组治疗效果。结果 Surgiflo组术中止血时间、术中出血量、术后1 d和2 d引流量、术后1 d JOA评分均优于明胶海绵组,差异有统计学意义(P 0.05);2组末次随访JOA评分差异无统计学意义(P 0.05)。Surgiflo组和明胶海绵组术后伤口感染发生率分别为0和1.5%(1/65)。结论可吸收止血流体明胶是一种安全、有效的止血剂,在钩椎关节切除手术中可减少术中止血时间、术中出血量、术后引流量,且围手术期症状缓解迅速,不增加伤口感染的风险。     

Damage control management of experimental grade 5 renal injuries: further evaluation of FloSeal gelatin matrix

BACKGROUND: We developed a porcine grade 5 renal laceration damage control model to evaluate the hemostatic efficacy of FloSeal gelatin matrix (Baxter Healthcare, Corp., Deerfield, Ill). METHODS: Ten commercial swine underwent celiotomy, contralateral nephrectomy, and cooling to 32 degrees C after a well-established hypothermia protocol to simulate a damage control scenario. Following prospective randomization, a complex grade 5 renal injury was uniformly produced on the remaining kidney. Control animals (group 1, n = 5) were treated with direct manual compression with a gelatin sponge. Experimental animals (group 2, n = 5) were treated by application of FloSeal gelatin matrix followed by direct compression with a gelatin sponge. Operative blood loss and efficacy of hemostasis were compared. Creatinine levels were obtained daily until postoperative day 7. Abdominal computed tomography was performed at 10 days. RESULTS: Use of FloSeal gelatin matrix hemostatic sealant resulted in significantly less mean blood loss than gelatin sponge bolster compression alone (202.4 mL vs. 540.4 mL, respectively, p = 0.016). Hemostasis was complete in 60% (three out of five) of experimental animals after 2 minutes, but was incomplete in all control animals. After an initial increase, serum creatinine approached baseline by postoperative day 7 in all animals. Axial imaging 10 days postoperatively revealed no evidence of significant delayed perirenal hemorrhage. CONCLUSIONS: FloSeal gelatin matrix performed well as a rapidly deployable, effective hemostatic agent in a hypothermic grade 5 renal injury damage control model. The absence of delayed bleeding and nephrotoxicity suggests a possible increased role for FloSeal in the treatment of devastating renal injuries in damage control surgery.     

Central renal stab wounds: treatment with augmented fibrin sealant in a porcine model

PURPOSE: We determined whether fibrin sealant augmented by an absorbable bolster could salvage kidneys with major, centrally located stab wounds. MATERIALS AND METHODS: A grade 4 renal injury was created in 16 commercial swine via a 1.5 cm sagittal, centrally located, through-and-through right renal laceration. Animals were randomized to 1 of 4 treatment arms, including control groups that received conventional renal capsule suture repair with an absorbable gelatin sponge bolster (3 in group 1) or a microfibrillar collagen sheet (3 in group 2) and experimental groups that received sutureless treatment entailing fibrin sealant instillation into the knife tract augmented by an external gelatin sponge (5 in group 3) or an external microfibrillar collagen sheet (5 in group 4). Arterial occlusion was not performed. Blood loss and time to hemostasis were recorded. Abdominal computerized tomography was performed at 1 week and necropsy was done at 6 weeks. RESULTS: Renal reconstruction with fibrin sealant resulted in significantly lower blood loss (62 vs 155 ml, p <0.05) and time to hemostasis (3.5 vs 6.5 minutes, p <0.05) than in the conventional suture groups. There was no radiographic or gross evidence of significant postoperative bleeding, urinoma formation or abnormal tissue healing in the recovery period. Gelatin sponge and collagen sheet demonstrated similar hemostatic efficacy. CONCLUSIONS: In this porcine renal trauma model fibrin sealant augmented by absorbable gelatin sponge or a microfibrillar collagen sheet effectively promoted hemostasis and renal salvage. Because of its safety, ease of use and efficiency, fibrin sealant appears to be an appropriate adjunct for managing challenging renal injuries.