Gelatin matrix treatment of complex renal injuries in a porcine model

PURPOSE: We developed a complex porcine renal laceration model at our laboratory to test the efficacy of an abbreviated, sutureless treatment regimen using FloSeal gelatin matrix hemostatic sealant (Baxter Healthcare Corp., Fremont, California). We evaluated the influence of preliminary renal arterial occlusion on hemostatic efficacy and assessed the risk of delayed hematoma or urinoma formation after treatment. MATERIALS AND METHODS: A total of 21 commercial swine underwent celiotomy with creation of a complex upper pole renal injury using a 4 x 4 cm cruciate press instrument. The injury was uniformly produced at the caudal extent of the upper third portion of the left kidney. Subjects were prospectively randomized into 3 treatment groups. Experimental animals were treated with the application of gelatin matrix with (7 in group 1) or without (7 in group 2) preliminary renal arterial occlusion. Control subjects (7 in group 3) were treated with conventional horizontal mattress sutured gelatin sponge bolsters over the capsular injury. Operative blood loss, time to hemostasis and volume of gelatin matrix required for hemostasis were compared among the groups. Abdominal computerized tomography with intravenous contrast medium was performed in each animal 7 days postoperatively. RESULTS: Gelatin matrix use resulted in significantly less mean blood loss (80.7 and 99.0 ml in groups 1 and 2, respectively) vs conventional suture treatment (191.8 ml in group 3, p = 0.036). Time to hemostasis was similarly decreased (1.1, 2 to 2.5 and 5.8 minutes in groups 1 to 3, respectively, p = 0.009). Followup abdominal computerized tomography with contrast medium revealed no clinically significant perinephric fluid collections (greater than 2 cm). CONCLUSIONS: FloSeal gelatin matrix hemostatic sealant provided effective hemostasis after complex renal injury with and without preliminary vascular control. No delayed bleeding or clinically significant urinoma formation was noted. These findings suggest a possible increased role for FloSeal gelatin matrix in renal salvage 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.     

Effects of commonly used hemostatic agents on the porcine collecting system

PURPOSE: Topical hemostatic agents have been particularly useful for preventing bleeding in tubeless percutaneous nephrolithotomy. In the present study, we investigated the effect of gelatin matrix hemostatic sealant (FloSeal), fibrin glue (Tisseel,), polyethylene glycol polymers (CoSeal), and bovine serum albumin/ glutaraldehyde (BioGlue) in the pig urinary collecting system after injection through a percutaneous nephrostomy (PCN) tract. MATERIALS AND METHODS: Percutaneous nephrostomy was performed in 40 kidneys in 24 domestic pigs. Animals were divided into four groups of six each: (1) FloSeal; (2) Tisseel; (3) CoSeal; and (4) BioGlue. In 16 animals that tolerated the procedure, the contralateral kidney was used as a control for PCN only. All tracts were dilated to 30F with the Amplatz dilator, and 2 mL of the hemostatic agent was injected into the collecting system before pulling back to seal the puncture. RESULTS: Among the control PCN kidneys, no obstruction was detected at the end of a 5-day period. However, three of six kidneys injected with FloSeal, Tisseel, or CoSeal and four of six kidneys injected with BioGlue were obstructed. In each of these cases, there was an associated retroperitoneal urinoma. CONCLUSION: FloSeal, Tisseel, CoSeal, and BioGlue, if injected directly into the porcine collecting system, can result in significant obstruction that does not resolve over a 5-day period. Until there are clinical data to the contrary, we believe that when using one of these hemostatic agents in association with a tubeless percutaneous procedure, a retrograde occlusion balloon catheter should be considered to prevent inadvertent injection of these materials into the collecting system.     

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。     

Evaluation of FloSeal as a potential intracavitary hemostatic agent

BACKGROUND: Noncompressible hemorrhage is a major cause of death in combat and civilian trauma. When surgery is unavailable, one potential solution to such hemorrhage might be the introduction of an agent into the closed body cavity to provide hemostasis via a combination of coagulative and tamponade effects. FloSeal is an agent containing collagen and thrombin with proven hemostatic efficacy when applied with manual pressure to a bleeding site. The current studies were conducted to analyze the ability of FloSeal to reduce blood loss and increase survival time when applied directly, immediately, and without additional pressure to a severe liver injury in rats. METHODS: Male rats were anesthetized and catheters were placed in the carotid artery (for measurement of blood pressure) and jugular vein (for resuscitation with lactated Ringers, 3.3 mL/min/kg BW). After midventral laparotomy, the liver was exposed and caudal portions of both medial lobes ( approximately 1% of body weight) were rapidly excised. FloSeal (5 mL, 800 units Thrombin/mL) or vehicle (5 mL, 0.9% NaCl) was directly and immediately applied to the cut liver surface. The abdominal cavity was closed and resuscitation initiated. After hemorrhage-induced death, or after euthanasia at 90 minutes, fluid loss (blood + resuscitation fluid) was measured. RESULTS: Compared with the control group, direct and immediate application of FloSeal was associated with a reduction in the amounts of fluid lost into the abdominal cavity (p < 0.01) (19.2 +/- 1.5 versus 25.1 +/- 1.5 g) and enhanced mean arterial pressure at 5, 20, and 30 minutes after injury (p = 0.02), but neither survival time (p = 0.12) nor percent survival (p = 0.17) differed between treated and control groups. CONCLUSIONS: Reductions in fluid loss after liver injury and hemorrhage in FloSeal-treated rats in the absence of additional applied pressure are encouraging, and provide evidence for the ability of FloSeal to reduce blood loss when applied immediately and directly to a bleeding tissue.     

Tubeless percutaneous nephrolithotomy using hemostatic gelatin matrix

We describe using hemostatic gelatin matrix (FloSeal; Baxter Inc., Irvine, CA) to provide hemostasis of the tract after percutaneous nephrolithotomy, thereby obviating a nephrostomy tube. For patients who are rendered stone free, a 7F, 11.5-mm occlusion balloon catheter, passed retrograde, is used to occlude the collecting system at the level of entry of the 30F Amplatz sheath. FloSeal is then injected through the partially retracted Amplatz sheath while withdrawing the applicator and the sheath in tandem. The guidewire is withdrawn per urethra until its tip resides in the renal pelvis. A 36-cm, 7F tail stent is passed retrograde, and the skin is closed with cyanoacrylate adhesive (Ethicon, Somerville, NJ). A Foley catheter is placed, to be removed the next morning; the patient can be discharged on postoperative day 1. The ureteral stent is removed in 5 to 7 days as an outpatient procedure.     

High-pressure fibrin sealant foam: an effective hemostatic agent for treating severe parenchymal hemorrhage

BACKGROUND: The majority of early trauma deaths are related to uncontrolled, noncompressible, parenchymal hemorrhage from truncal injuries. The purpose of this study was to formulate a fibrin sealant foam (FSF) able to control severe parenchymal bleeding without compression or vascular control. MATERIALS AND METHODS: FSF with high fibrinogen concentration (20 mg/mL) and low thrombin activity (5 U/mL) was prepared and pressurized by addition of liquid gas propellant. The efficacy of this foam was tested against a severe parenchymal hemorrhage, created by partial resection of liver lobes in anticoagulated rabbits (n = 7) and compared to untreated injury (n = 8) and placebo treatment (n = 7). The hemostatic efficacy of pressurized FSF (n = 8) was also compared to a commercially available liquid fibrin sealant (n = 8) and a developing dry powdered fibrin sealant product (n = 8) in the same model. RESULTS: The liver injury resulted in 122 +/- 11.5 mL blood loss and death of 75% of untreated rabbits (3.2-3.4 kg) within 1 h. Treatment with placebo foam had no effect on blood loss or mortality rate. Pressurized FSF significantly reduced bleeding, resulting in 56% (P < 0.05) and 66% (P < 0.01) reduction in blood loss as compared to untreated or placebo-treated animals, respectively, and 100% survival (P = 0.008). When pressurized FSF was compared with liquid and powdered forms of fibrin sealant, only foam significantly reduced blood loss (49%, P < 0.05) and mortality rate (54%, P < 0.05) of rabbits as compared to untreated control animals (n = 9). CONCLUSION: Biological nature, rapid preparation, coverage of large wound areas, and effective hemostatic properties make pressurized FSF an ideal candidate for treating nonoperable parenchymal injuries in damage control procedures.     

诱发电位监测脊髓缺血性损害的实验研究

目的：探索术中诱发电位对脊髓缺血性损害的监测作用。方法：12只犬,随机分为3组,分别行单纯主射造影剂、使用明胶海绵和碘油作栓塞剂栓塞单侧肋间动脉（左T8／9）造成脊髓缺血,术中应用运动诱发电位（MEPs)和体感诱发电位（SEPs)监测,观察术中,术后MEPs与SEPs的变化,比较各各组术后运动分级和病理检查结果。结果：注射造影剂或栓塞剂时SEPst MPEs潜伏期均有不同程度的延长,波幅均有不同程度的下降,但单纯造影组5min后恢复,明胶海绵组30min恢复,碘油组30min仍未见恢复。MEPs变化与运动功能分级一致,SEPs和MEPs都与病理形态相关。结论：SEPs、MEPs对脊髓缺血性损害具有良好的监测作用;MEPs 的改变与术后脊髓运动功能相关。     

Controlled clinical trial of a novel hemostatic agent in cardiac surgery. The Fusion Matrix Study Group

BACKGROUND: We performed a prospective randomized trial to compare FloSeal Matrix (Fusion Medical Technologies, Inc, Mountain View, CA), a gelatin-based hemostatic sealant, with Gelfoam-Thrombin (Gelfoam, Pharmacia and Upjohn, Kalamazoo, MI; Thrombin, Gentrac Inc, Middeton, WI) (control group) to control perioperative bleeding. METHODS: A total of 93 patients undergoing cardiac operations were randomized into the FloSeal or control group after standard surgical means to control bleeding had failed. The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after applying the hemostatic agent. If bleeding stopped within 10 minutes, the application was considered to be successful. In the case of a failure, the surgeon could use any means preferred (except FloSeal) to achieve hemostasis. All bleeding sites in a patient were treated with the hemostatic agent to which the patient was randomized. Follow-up evaluation was performed at 12 to 36 hours and 6 to 8 weeks after operation. RESULTS: FloSeal stopped bleeding in 94% of the patients (first bleeding site only) within 10 minutes, compared to 60% in the control group (p = 0.001). At 3 minutes, successful hemostasis was achieved in 72% of the FloSeal group compared with 23% in the control group (p = 0.0001). There was no difference in the adverse event profile between the two groups. CONCLUSIONS: FloSeal Matrix demonstrated efficacy superior to that of Gelfoam-Thrombin and had a safety profile similar to that of Gelfoam-Thrombin when used as a topical hemostatic agent during cardiac surgery procedures.     

What happens to hemostatic agents in contact with urine? An in vitro study

BACKGROUND AND PURPOSE: As the indications for topical hemostatic agents increase in urology, the question arises: what happens to these agents when they enter the urinary collecting system? To answer this question, we performed a series of in-vitro experiments mixing three hemostatic agents with normal and sanguineous urine. MATERIALS AND METHODS: Four commercially available topical hemostatic products: oxidized regenerated cellulose (Surgicel; Ethicon, Somerville, NJ), fibrin sealant (Tisseel VH Kit; Baxter Health Care Corporation, Irvine, CA), gelatin matrix hemostatic sealant (FloSeal; Baxter Health Care), and polyethylene glycol (CoSeal; Cohesion Technologies, Palo Alto, CA) were studied. Human urine (10 mL) was added to samples of each substance; this was done in triplicate. The 12 sample tubes were then capped and placed on a tube shaker at slow speed and 37 degrees C. Observations regarding consistency of the material were made at 6, 12, 24, 48, 72, 96, and 120 hours (5 days). Gelatin matrix hemostatic sealant was further tested in urine with various amounts of blood or blood clot; observations were again recorded out to 5 days. RESULTS: Surgicel maintained its solid form when it initially came in contact with urine, but over a period of 5 days, it transformed into a mucoid substance with visible free-floating fibers. It did not dissolve completely in urine within 5 days. Gelatin matrix was immediately transformed by urine into a fine colloidal suspension that did not change over the 5 days of the study. Fibrin glue, after mixing of the two components (fibrinogen and thrombin) directly in the urine, and polyethylene glycol immediately formed a solid clot at the bottom of the test tube on contact with the urine. When the mixture of fibrin sealant was allowed to form for 15 minutes and then added to urine, it again maintained a solid form. After 72 hours, the fibrin glue became a semisolid gelatinous plug. On analysis at 5 days, the fibrin sealant clot had transformed into a cohesive mucoid gel, and the polyethylene glycol clot had not changed. The gelatin matrix hemostatic sealant, when in contact with blood or blood clot, appeared to either become part of a clot or to remain in a colloidal suspension. At 5 days, all clots had dissolved to fine particulate suspensions, and the gelatin matrix appeared as a fine suspension. CONCLUSION: Fibrin glue and oxidized regenerated cellulose maintain a solid form when initially placed in direct contact with urine and then assume a semisolid gelatinous state, which is still present at 5 days. Polyethylene glycol forms a solid clot initially and does not change after 5 days. Only hemostatic gelatin matrix remained as a fine particulate suspension in both normal and sanguineous urine. The implications of these findings with regard to sealing the renal parenchyma or small violations of the collecting system after percutaneous or laparoscopic surgery await in-vivo testing.     

Radiofrequency tissue ablation in an experimental model of grade IV renal trauma: a preliminary report

Background The kidney is one of the most frequently injured intraabdominal organs. In this study, we investigated the efficacy and safety of radiofrequency ablation (RFA) as a kidney-preserving hemostatic technique for grade IV renal trauma.Methods A grade IV injury was induced in the right kidney of 12 Landrace pigs. Then RFA was applied around the injury in 10 animals until hemostasis was achieved; two animals were not treated (control group). The treated animals were killed humanely on days 0, 3, 7, 14 and 21 and examined. The kidneys were subjected to histologic and radiologic examination.Results The two untreated animals died from hypovolemic shock. Hemostasis was achieved in all treated animals. We had no operative deaths and no morbidity. No blood, pus, urine, or other fluid was found at the time of death. In one animal, a fistulous lesion leading to the collecting system was identified, but no urine leakage was observed. At histology, the ablated areas were found to consist of three zones: an inner necrotic one, a zone of neutrophils digesting necrotic tissue, and an outer zone with possibly reversible damage.Conclusions Radiofrequency ablation is an efficient and safe hemostatic method for grade IV renal trauma. Further study is needed to investigate the possible application of this method to humans and its percutaneous or laparoscopic use.     

Assessment of topical hemostats in a renal hemorrhage model in heparinized rats

Various topical hemostatic agents or devices have been employed to address the challenges associated with hemorrhage from parenchymal organs during surgery or trauma. Their relative efficacy, however, has not been assessed in a single animal model. The objective of this study was to develop a small animal renal hemorrhage model for comparing hemostatic efficacy of various topical agents, and then to compare fibrin sealant (FS) to an existing standard of care for topical hemostasis. A left heminephrectomy was performed in anesthetized adult male Sprague-Dawley rats. Animals were anticoagulated with 2000 IU/kg heparin IV and various topical hemostatic agents were applied to the injury. Treatment groups included FS applied as a spray; FS applied through a cannula; gelatin sponge (GS) soaked in 1000 IU/mL thrombin solution; GS soaked in 300 IU/mL thrombin; dry GS; and fibrinogen without thrombin applied as a spray. The main endpoints of the study were incidence of hemostasis, blood loss, acute survival trends, and maintenance of mean arterial pressure (MAP). Three treatment groups, the two FS groups and the GS soaked in 1000 IU/mL thrombin, afforded significant hemostasis compared to the controls (P < 0.01). Both FS groups had significantly less blood loss, longer survival times, and maintained higher MAPs than the GS-treated groups. Quantitative dose effects and functional deficiencies in topical hemostatic products could be assessed using this animal model. The study demonstrated that liquid FS was significantly more efficacious than a GS soaked in thrombin for abating hemorrhage from a renal excision in a heparinized rat.     

Use of FloSeal hemostatic sealant in transsphenoidal pituitary surgery: technical note

OBJECTIVE: Bleeding during transsphenoidal pituitary surgery can lead to a variety of operative difficulties. When the endonasal transsphenoidal approach is used, even mild intraoperative hemorrhage can lessen visibility in the confined operative field of view. This technical note describes the use of a hemostatic agent we have found of benefit in obtaining prompt hemostasis during this operation. METHODS: Operative records were reviewed for an 18-month period for all patients who underwent transsphenoidal surgery since we began using FloSeal hemostatic sealant in January 2000. RESULTS: During the study period, 293 transsphenoidal operations were performed for pituitary lesions. Of these, 20 procedures involved vigorous or persistent bleeding. When the standard techniques for hemostasis failed or were inadequate, FloSeal, a sterile mixture of a gelatin matrix and thrombin component mixed at the time of use, was applied to the site of hemorrhage by use of a 14-gauge angiocatheter to reach the sella. We observed complete hemostasis immediately on application of FloSeal in all cases except one, which required a second application. Hemostasis was obtained immediately after the second application. No operations were aborted during this period as a consequence of undue bleeding. CONCLUSION: We detail the method in which we use FloSeal in transsphenoidal surgery and report our impression of its effectiveness. FloSeal has been demonstrated to be safe and biocompatible as compared with hemostatic agents currently in use.     

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。     

Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA

Bleeding after total knee arthroplasty increases the risk of pain, delayed rehabilitation, blood transfusion, and transfusion-associated complications. The authors compared pre- and postoperative decreases in hemoglobin as a surrogate for blood loss in consecutive patients treated at a single institution by the same surgeon (J.L.C.) using conventional hemostatic methods (electrocautery, suturing, or manual compression) or a gelatin and thrombin-based hemostatic matrix during total knee arthroplasty. Data were collected retrospectively by chart review. The population comprised 165 controls and 184 patients treated with hemostatic matrix. Median age was 66 years (range, 28-89 years); 66% were women. The arithmetic mean ± SD for the maximal postoperative decrease in hemoglobin was 3.18 ± 0.94 g/dL for controls and 2.19 ± 0.83 g/dL for the hemostatic matrix group. Least squares means estimates of the group difference (controls-hemostatic matrix) in the maximal decrease in hemoglobin was 0.96 g/dL (95% confidence interval, 0.77-1.14 mg/dL; P<.0001). Statistically significant covariate effects were observed for preoperative hemoglobin level (P<.0001) and body mass index (P=.0029). Transfusions were infrequent in both groups. The frequency of acceptable range of motion was high (control, 88%; hemostatic matrix, 84%). In both groups, overall mean tourniquet time was approximately 1 hour, and the most common length of stay was 3 to 5 days. No serious complications related to the hemostatic agent were observed. These data demonstrate that the use of a flowable hemostatic matrix results in less reduction in hemoglobin than the use of conventional hemostatic methods in patient undergoing total knee arthroplasty.     

颈椎前路手术中硬膜损伤的预防与治疗

目的探讨如何预防与治疗颈椎前路手术中出现的硬膜损伤。方法回顾分析2011年10月—2015年10月在本院接受治疗的72例颈椎前路手术中硬膜损伤患者的临床资料。术中行明胶海绵、生物蛋白胶封堵30例,皮下筋膜组织覆盖缺损处加明胶海绵、生物蛋白胶黏合加固42例。其中32例术后48 h切口引流200 m L/d,后续采用持续常压引流加弹力绷带适度绕颈环形加压的方法治疗;40例术后48 h切口引流200 m L/d,后续采用腰大池引流结合弹力绷带适度绕颈环形加压的方法治疗。术后常规卧床,预防感染,营养支持治疗。结果 32例持续常压引流的患者恢复至脑脊液漏停止的平均时间为6.4 d,40例腰大池引流的患者平均恢复时间为11.2 d。所有患者术后神经功能均显著改善,切口愈合良好,无感染发生。仅1例发生颈前脑脊液假性囊肿,经反复穿刺抽吸加腰大池引流无效,于术后半年行颈椎前路囊肿切除修补术后痊愈。结论充分的术前评估及熟练的手术技巧对于减少颈椎前路手术中硬膜损伤至关重要。对于已经形成的硬膜损伤,术中采取明胶海绵、生物蛋白胶封堵或皮下筋膜组织覆盖缺损处结合明胶海绵、生物蛋白胶黏合加固,再辅以术后伤口引流、腰大池引流等措施,可以取得满意疗效。     

纤维蛋白原-胶原海绵片在肝手术创面的止血及组织封闭作用的动物实验研究

目的探讨纤维蛋白原鄄胶原海绵片在手术创面的止血性能、封闭创面的效果及在体内降解吸收的状况。方法将SD大鼠20只随机分成实验组和对照组。实验组用纤维蛋白原鄄胶原海绵片进行止血,对照组用明胶海绵片止血。结果在大鼠肝表面的切口,两种止血材料均能即刻止血。纤维蛋白原鄄胶原海绵片与切口粘附紧;而明胶海绵片较易脱落。在大鼠左肝前叶切除术中,纤维蛋白原鄄胶原海绵片组在止血时间及出血量的指标上均优于明胶海绵片组(P<0.05)。组织学检查:创面炎症消退、止血材料降解和促肝细胞再生,实验组均优于对照组。结论纤维蛋白原鄄胶原海绵片能有效地止血,与创面的粘附力强,吸收降解快,且能诱导肝创面肝细胞再生。因而,纤维蛋白原鄄胶原海绵片是一种安全的局部止血、组织封闭和促进细胞再生的生物材料。     

Use of gelatin-thrombin matrix hemostatic sealant in cranial neurosurgery

The present study evaluated the hemostatic efficacy and handling of gelatin-thrombin matrix hemostatic sealant during intracranial procedures. A retrospective analysis of 478 consecutive patients undergoing intracranial procedures identified seven patients with acute intense or persistent intraoperative bleeding which could not be arrested in time by standard hemostatic methods. The efficacy of gelatin-thrombin matrix was assessed by determining bleeding severity before and after application, time to hemostasis, amount of gelatin-thrombin matrix necessary, need for additional hemostatic measures, and need for reoperation to control hemorrhage. Immediate hemostasis was achieved in five of seven patients. Two of these five patients had abnormal clotting parameters. Cessation of bleeding was achieved by additionally applying either fibrinogen or gelatin sponge to the bleeding site in the other two patients. No complications attributable to gelatin-thrombin matrix use were recorded. The gelatin-thrombin matrix was ready to use within 1 minute in every case. Gelatin-thrombin matrix appears to be an effective, easy-to-use, and readily available hemostatic agent for cranial neurosurgery. Combination with fibrinogen is recommended in special situations.     

Small bowel obstruction after FloSeal use

Objective:

FloSeal is a thrombin-gelatin hemostatic matrix that is used to obtain hemostasis. There have been isolated case reports of FloSeal causing bowel obstructions, requiring surgical intervention. We report 3 cases of what we believe were FloSeal-induced small bowel obstructions (SBO).

Methods:

We present a series of small bowel obstructions after FloSeal use. Our series includes urology, gynecologic oncology, and general surgery cases at the same institution where the product was appropriately used and resulted in the same complication.

Results:

FloSeal was used for hemostasis in all patients. In each instance, a small bowel obstruction developed in 7 days to 9 days. All patients were reexplored laparoscopically and found to have an intense inflammatory reaction at the site of the FloSeal. The adhesions were lysed and the obstructions resolved.

Conclusions:

Although further study is needed, the common factor in all these SBOs was a hemostatic agent. In our and others’ series, the time to SBO was 7 days to 9 days. If an early postoperative SBO occurs after FloSeal is used, prompt reexploration should be considered.     

The effectiveness of FloSeal® matrix hemostatic agent in thyroid surgery: a prospective,randomized, control study

Background

The objective of this study was to compare the effectiveness of FloSeal® matrix hemostatic agent with hemostatic surgical procedures and Tabotamp® in thyroid surgery.

Methods

One hundred fifty-five consecutive total thyroidectomy patients were recruited at our institution between January 2005 and December 2007. Exclusion criteria were applied. Patients were randomized to one of three hemostatic approaches: 49 received surgical procedures only, and 52 received oxidized regenerated cellulose patch (Tabotamp Fibrillar 2.5?×?5 cm) and 54 FloSeal (5,000 U/5 mL). The same surgeon performed all operations.

Results

Mean operating time was reduced in the FloSeal group (105 min) vs. surgical (133 min, p?=?0.02) and vs. Tabotamp (122 min, p?=?0.0003). Also, wound drain removal occurred earlier with FloSeal (p?=?0.006 vs. surgical; p?=?0.008 vs. Tabotamp) resulting in shorter postoperative hospital stay in the FloSeal group (p?=?0.02 vs. surgical; p?=?0.002 vs. Tabotamp).

Conclusions

FloSeal matrix is an effective additional agent to conventional haemostatic procedures in thyroid surgery.