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.     

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.     

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.     

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.     

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.     

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.     

Introducing a new sealant applicator for easy, safe, and quick closure of a mini-percutaneous nephrolitholapaxy access tract

PURPOSE: To achieve better hemostasis after mini-percutaneous nephrolitholapaxy (mini-PCNL), we developed a new application device that can be used to close the renal-access tract with gelatin matrix hemostatic sealant (GMHS). PATIENTS AND METHODS: After mini-PCNL was performed on 11 patients, a Double-J ureteral stent was placed antegrade. After retraction of the 18F Amplatz sheath out of the collecting system under vision without irrigation, the urothelium collapsed. The 15F metal applicator with a 10F working channel was then inserted and GMHS injected during further retraction of both the device and the Amplatz sheath. The skin was closed with Steri-strips. RESULTS: The renal parenchymal tract of the mini-PCNL can be sealed in 15 to 50 seconds. Postoperatively, no urinoma was observed. All patients had an uneventful follow-up. CONCLUSION: Closing the track of the mini-PCNL with the new application device and GMHS is a safe, easy, and quick alternative to the common nephrostomy tube.     

Improvement of hemostasis in laparoscopic and open partial nephrectomy with gelatin thrombin matrix (FloSeal)

Long-term follow-up studies have demonstrated that effective local tumor control and long-term tumor-free progression rates can be achieved by nephron-sparing surgery. However, hemostasis is a major issue and the lack of effective means of hemostasis has limited a wider use of the laparoscopic approach to nephron-sparing surgery. Between January 2001 and August 2002, a total of 36 patients with renal cell carcinomas were treated by partial nephrectomies using a two-component tissue sealant (FloSeal). The median age was 55.2 years (range: 34-71 years). Follow-up time was 1-18 months (median: 5.5 months). The tumor diameter ranged from 2 to 5 cm (median: 2.9 cm). Open retroperitoneal surgery was performed in 17 cases and laparoscopic partial nephrectomy in 19 cases. The two-component tissue sealant (consisting of a gelatin matrix with granular and thrombin components) was applied after resection of the tumor and before perfusion of the kidney. The following parameters were recorded: (1) time until complete hemostasis was achieved, (2) decrease in postoperative hemoglobin level, (3) postoperative bleeding, and (4) presence or absence of a perirenal hematoma 24 h and 10 days postoperatively by ultrasound. After application of the tissue sealant for 1-2 min to the moist resection site, hemostasis was immediate in all cases. During the laparoscopic partial nephrectomies, a laparoscopic applicator was used that avoided wasting the tissue sealant within the dead space of the instrument. When reperfusion of the kidney was established, hemostasis was maintained. The decrease in postoperative hemoglobin level ranged from 0.3 to 1.2 points (median: 0.8 points). None of the patients required blood transfusions. There were no cases of postoperative bleeding. An ultrasound examination 24 h and 10 days postoperatively demonstrated the absence of a significant perirenal hematoma. The two-component tissue sealant FloSeal provided immediate and durable hemostasis in open and laparoscopic partial nephrectomies. The tissue sealant may provide a tool to expand the possibilities of laparoscopic nephron-sparing surgery.     

Controlled survival study of the effects of Tisseel or a combination of FloSeal and Tisseel on major vascular injury and major collecting-system injury during partial nephrectomy in a porcine model

PURPOSE: We report the results of a controlled survival study in a porcine model investigating Tisseel or a combination of FloSeal and Tisseel in dealing with vascular and collecting-system injury during partial nephrectomy. MATERIALS AND METHODS: We performed an open right lower-pole partial nephrectomy on 15 large female pigs. The defect was repaired using standard open techniques (N = 5; controls), Tisseel only (N = 6; group I), or FloSeal followed by Tisseel (N = 4; group II). A Jackson-Pratt drain was placed. Nephrectomy and retrograde pyelography were performed at 1 week. RESULTS: Operative times were shorter in both study groups, achieving statistical significance in group I (P = 0.008). Warm-ischemia times were significantly improved in both study groups (P = 0.029 and P = 0.00005 in groups I and II, respectively). Time to hemostasis was significantly shorter in group II only (P = 0.002) but approached significance in Group I as well (P = 0.09). Estimated blood loss was not significantly different from the controls in either group. When Tisseel was placed alone after hilar control, hematoma formation under the Tisseel was noted on release of the hilar clamp. After 1 week, there was one urinoma and three urine leaks in the control group. In group I, there was one urinoma and four urine leaks, and there was only one urine leak and no urinomas in group II. There were no hematomas in any of the groups. CONCLUSIONS: Tisseel alone is not adequate for either hemostasis or management of major collecting-system injury. FloSeal capped with Tisseel appears sufficient to control major vascular and collecting-system injuries without adjunctive surgical measures. A proposed technique for laparoscopic partial nephrectomy without reconstructive techniques is presented that warrants clinical study.     

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.     

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.     

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.     

Use of Hemostatic Matrix for Hemostasis of the Cavernous Sinus during Endoscopic Endonasal Pituitary and Suprasellar Tumor Surgery

The endoscopic endonasal approach offers a wide, panoramic exposure of the sellar floor, planum, and clivus. The ability to expose fully the tumor margins, through lateral extension of cavernous sinuses, increases the exposure and ability to resect the tumor but increases the risk of bleeding. The authors describe achieving hemostasis using a hemostatic matrix, FloSeal (Baxter Biosciences, Vienna, Austria) sealant, during endoscopic endonasal tumor removal, specifically for pituitary and suprasellar tumors. Thirty-nine cases (33 pituitary adenomas, 4 craniopharyngiomas, 1 clival plasmacytoma, and 1 planum meningioma) are described using this technique. FloSeal was injected directly to the site of bleeding, and a cottonoid was used for further tamponade, immediately achieving hemostasis with no hemorrhagic complications in any of the patients. Surgery could be immediately pursued without any delay. This simple nuance can be used as a safe method in cavernous sinus hemostasis during endoscopic endonasal surgery and may decrease operative time.     

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.     

Comparative study of the efficacy of the common topical hemostatic agents with fibrin sealant in a rabbit aortic anastomosis model

OBJECTIVE: The purpose of this study was to compare the hemostatic efficacy of the common surgical hemostatic agents with fibrin sealant (FS) and to assess their functional strength to secure hemostasis in lieu of placing additional sutures. METHODS: End-to-end anastomosis of transected abdominal aorta was performed in moderately anticoagulated rabbits using 4 or 6 interrupted sutures. The suture line was covered either with gauze alone ("untreated") or with gauze plus Gelfoam, Avitene, Surgicel, FloSeal, or FS, following which blood flow was restored. Blood loss was absorbed by gauze and measured. The surviving rabbits were recovered and the repaired vessel was examined histologically 4 weeks after operation. The investigators were blinded to the treatment groups. Aortic anastomoses using 8 or 12 sutures (untreated) were also performed. RESULTS: Untreated 4-suture anastomosis of aorta resulted in a profuse hemorrhage with an average 108.0 +/- 19.2 (mean +/- SD) ml blood loss and 100% mortality (n = 4). FS application sealed the anastomoses, prevented blood loss (P < 0.01 vs untreated) and exsanguination of the rabbits (n = 4). Other hemostatic agents reduced the bleeding to varying degrees compared to the untreated animals (Gelfoam 66.4 +/- 17.6, Avitene 80.6 +/- 34, Surgicel 66.7 +/- 16.7, FloSeal 44.2 +/- 8.5 ml blood loss, n = 4/group), but the changes were not statistically significant. One to three rabbits in each group survived the operation. Six-suture aortic anastomoses, untreated, resulted in 67.7 +/- 21.8 ml blood loss and 100% survival (n = 6). Application of FS produced immediate and sustained hemostasis in all the animals (P < 0.01 vs untreated). Other hemostatic agents also reduced the bleeding (Gelfoam 42.5 +/- 10, Avitene 50.9 +/- 12.4, Surgicel 32.1 +/- 14, FloSeal 33.9 +/- 5.4 ml blood loss, n = 6/group), but the changes were not statistically significant. The 8- and 12-suture aorta repairs resulted in a moderate blood loss (43.9 +/- 19 and 21.3 +/- 14.9 ml, respectively), followed by a stable hemostasis that precluded the need to use any hemostatic agent. The aortic cross-clamping time of the 12-suture and time to hemostasis for both the 8- and the 12-suture techniques were significantly longer than those of the 4-suture plus FS application (P < 0.01, P < 0.01 and P < 0.05, respectively). CONCLUSION: In a moderate coagulopathy, FS was proven to be the most efficacious hemostatic agent, producing immediate and sustained hemostasis at the arterial anastomotic site. This high efficacy is in part attributed to the strong tissue adhesive property of this agent. FS application may potentially ease the anastomosis and shorten the duration of timely critical vascular procedures.     

Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing adenoidectomy.

PROBLEM ADDRESSED: Floseal is a novel matrix hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin. It is applied as a high-viscosity gel for hemostasis and has been clinically proven to control bleeding. This study is a prospective, randomized, controlled clinical trial of Floseal sealant compared to traditional suction cautery hemostasis in children undergoing adenoidectomy. METHODS AND MEASURES: Seventy patients (mean age 7.0 yrs, 45.7% male) with obstructive sleep apnea underwent traditional cold steel adenoidectomy with an adenoid curette and were then randomized to receive the hemostatic sealant (Floseal) or cautery to obtain hemostasis. Patients were crossed over to the other hemostatic technique if hemostasis was not achieved after more than 100 mL of blood loss or 15 minutes elapsed time. Objective data collected included time to hemostasis and blood loss during hemostasis. Visual analog scales (VAS) were used to record subjective data by the operating surgeon including bleeding following adenoid pack removal (0 = none, 3 = brisk) and ease of operation (1 = extremely easy, 6 = extremely difficult). Parents recorded diet on a journal and were contacted by phone at postoperative day 7 and questioned with regard to return to regular diet and use of narcotics. RESULTS: Compared to patients in the cautery group (n = 35), Floseal patients (n = 35) had significantly shorter times to hemostasis (0.6 +/- 1.3 minutes vs 9.5 +/- 5.4 minutes [mean +/- SD], P < 0.001), less blood loss (2.5 +/- 9.2 mL vs 29.4 +/- 27.1 mL, P < 0.001), less subjective bleeding (0.0 +/- 0.6 vs 2.0 +/- 0.7, [median 4-point VAS +/- SD], P < 0.001), and subjectively easier operations (2.6 +/- 1.0 vs 5.2 +/- 1.0 [mean 6-point VAS +/- SD], P < 0.001). Furthermore, Floseal patients returned to regular diet earlier (2.7 +/- 0.7 vs 4.1 +/- 0.5 days [mean +/- SD], P < 0.001) and had less use of narcotics at 7 days postoperatively (40% vs 69%, P < 0.05). Lastly, three patients in the cautery group were crossed over to the Floseal group, but no Floseal subjects were crossed over to the cautery group. The retail cost of Floseal is US 85 dollars. Operating room costs are estimated at US 12 dollars/minute. Reducing the operative length by 8.9 minutes on average produces a cost savings of US 106.80 dollars per operation. There were no complications in either experimental group including postoperative hemorrhage, hospitalization, blood transfusion, or aspiration. CONCLUSIONS: Floseal matrix hemostatic sealant is a safe, efficacious, easy, and cost-effective technique for obtaining hemostasis in children undergoing adenoidectomy. Limitations of the study include the fact that it is nonblinded, which does allow for some bias in the subjective data recorded. However, utilizing 4 different operating surgeons, 3 of whom were not affiliated with the study, minimized this. CLINICAL SIGNIFICANCE OF STUDY: This study demonstrates the safety and efficacy of a novel hemostatic sealant in children undergoing adenoidectomy. Floseal matrix hemostatic sealant can be used as a first-line hemostatic agent, and it is a good tool in the armamentarium of otolaryngologists who encounter significant bleeding following adenoidectomy.     

Cross-linked matrix tissue sealant protects against mortality and hemorrhage in an acute renal injury model in heparinized rats

PURPOSE: We evaluated the efficacy of a cross-linked matrix tissue sealant compared with oxidized cellulose and electrocautery in an acute renal injury model. MATERIALS AND METHODS: Sprague-Dawley rats underwent partial nephrectomy after intravenous heparin anticoagulation. The cut surface received 1 of 4 therapies, namely no treatment, cross-linked matrix tissue sealant, electrocautery or Surgicel (Johnson & Johnson, New Brunswick, New Jersey) oxidized cellulose. Blood pressure was continually monitored, survival time was determined and total blood loss was quantified in each animal. RESULTS: Animals that received no treatment, electrocautery or oxidized cellulose died within 13 minutes of injury with a decline in blood pressure to 0 mm. Hg. In cross-linked matrix treated rats hemostasis was immediate, resulting in no blood loss after cross-linked matrix application. Mean arterial pressure +/- SEM was maintained at 136 +/- 6 mm. Hg. All cross-linked matrix treated animals survived. CONCLUSIONS: Cross-linked matrix tissue sealant provided immediate hemostasis and protection from a decline in blood pressure after renal trauma in heparinized rats. Cross-linked matrix tissue sealant may benefit patients with severe renal injuries. In the future cross-linked matrix may be useful for long-term partial nephrectomy repair.     

Prevention of post-operative pain and haemorrhage in PPH (Procedure for Prolapse and Hemorrhoids) and STARR (Stapled Trans-Anal Rectal Resection). Preliminary results in 261 cases

Intra- and early (first week) post-operative haemorrhages are the most common complications in stapled hemorrhoidectomy PPH (Procedure for Prolapse and Hemorrhoids) and in circumferential resection of the rectal prolapse STARR (Stapled Trans Anal Rectal Resection). Performing PPH and STARR we employed a gelatin based haemostatic sealant with thrombin component (FloSeal) to control intra-operative bleeding and to reduce post-operative bleeding avoiding haemostatic stitches on suture line. We report the preliminary results on 197 PPH and 64 STARR; 44 PPH (22.4%) and 27 STARR (42.2%) were treated by FloSeal. No major post-operative bleeding was observed in all patients treated by FloSeal, compared to 1.3% and 2.7% of hemorrhage respectively in PPH and STARR patients treated without sealant. Post-operative pain was less severe in patients treated by FloSeal, without a difference statistically significant. The data are preliminary and must be confirmed in prospective randomized trials in larger series.     

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。     

Treatment of grade 4 renal stab wounds with absorbable fibrin adhesive bandage in a porcine model

PURPOSE: In a porcine model we evaluated the efficacy of the absorbable fibrin adhesive bandage and other novel fibrin products for treating major renal stab wounds. MATERIALS AND METHODS: In commercial swine we produced an almost lethal, grade 4 renal stab wound via a 3.5 cm. sagittal, centrally located, through-and-through laceration. Each pig then received treatment in random fashion, including conventional oversewing of capsular defects with absorbable gelatin sponge and horizontal mattress sutures in 6, external absorbable fibrin adhesive bandage that was pressure held for 60 seconds in 6, external and internal absorbable fibrin adhesive bandage that was applied externally, inserted into the renal defect and pressure held for 60 seconds in 6, liquid fibrin sealant that was placed in the laceration and held for 60 seconds in 8, fibrin foam that was applied in the same manner as liquid fibrin in 5 and closing of the peritoneum over the lacerated kidney without further treatment in 6. Blood loss and time to hemostasis were recorded. Animals were sacrificed at 6 weeks to evaluate the injured renal unit. RESULTS: Compared with conventional therapy the absorbable fibrin adhesive bandage applied externally alone or externally and internally resulted in significantly less bleeding and significantly less time to hemostasis (p <0.001). Liquid fibrin and fibrin foam did not reliably achieve hemostasis. Postoperatively computerized tomography and histological sectioning suggested that the absorbable fibrin adhesive bandage results in a stable, durable clot and healing is at least as successful as with conventional treatment. CONCLUSIONS: The absorbable fibrin adhesive bandage appears to be a safe, rapid means of renal salvage after injury.