Hemostatic effect of Vivostat patient-derived fibrin sealant on split-thickness skin graft donor sites

Topical hemostatic agents are used frequently to control bleeding of skin graft donor sites. In this study, the hemostatic properties of Vivostat (Vivolution A/S, Birker?d, Denmark) patient-derived fibrin sealant were compared with a control group of spray thrombin solution, which is considered an industry standard for topical hemostasis. Treatments were applied simultaneously to two randomly chosen halves of a single split-thickness single donor site in patients in five United States surgical centers. The time to achieve satisfactory hemostasis (< or =10 min) was estimated on each half of the wound as the time at which active bleeding had stopped and the wound was suitable for application of a surgical dressing. The time to hemostasis of wounds treated with Vivostat (Vivolution A/S) patient-derived sealant was significantly shorter in comparison with wounds treated with thrombin solution (medians: Vivostat, 31 seconds; thrombin, 58 seconds; p=0.0012). No abnormalities in wound healing were reported for either treatment site 1 week after the operation. Vivostat (Vivolution A/S) sealant is a more rapidly effective topical hemostatic agent than thrombin on split-thickness skin graft donor sites.     

Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study

A multicenter study was conducted to test the efficacy and safety of fibrin sealant as a topical hemostatic agent in patients undergoing either reoperative cardiac surgery (redo) or emergency resternotomy. A total of 333 patients from 11 centers in the United States were included in the study. Patients were randomly assigned to initially receive the fibrin sealant or a conventional topical hemostatic agent when such was required during an operation. The end point used to evaluate the agent's efficacy was local hemostasis, the number of bleeding episodes controlled within 5 minutes. The fibrin sealant group from the prospective study was compared with historical matched control subjects for postoperative blood loss, need for resternotomy, blood products received, and hospital stay. It was also compared with historical nonmatched control subjects for the incidence of resternotomy and mortality. The results showed a 92.6% success rate for fibrin sealant in controlling bleeding within 5 minutes of application, compared with only a 12.4% success rate with conventional topical agents (p less than 0.001). Fibrin sealant also rapidly controlled 82.0% of those bleeding episodes not initially controlled by conventional agents. High-volume postoperative blood loss was significantly less (p less than 0.05) in the fibrin sealant group than in the matched controls. Additionally, resternotomy rates after redo operations were significantly lower in the fibrin sealant group (5.6%) than in the nonmatched historical control group (10%) (p less than 0.0089). There were no significant differences in hospital stay or blood products received between the fibrin sealant group and matched historical controls and no difference in mortality between the fibrin sealant group and nonmatched historical controls. There were no documented instances of adverse reactions, transmission of viral infection (hepatitis B, non-A/non-B hepatitis), or human immunodeficiency virus seroconversion. This study shows that fibrin sealant is safe and highly effective in controlling localized bleeding in cardiac operations. Fibrin sealant reduces postoperative blood loss and decreases the incidence of emergency resternotomy. These findings make fibrin sealant a valuable hemostatic agent in cardiac surgery.     

Multicenter trial to evaluate the safety and potential efficacy of pooled human fibrin sealant for the treatment of burn wounds

OBJECTIVE: The primary purpose of this multicenter study was to evaluate the safety and potential efficacy of a solvent/detergent-treated commercial fibrin sealant (human) for topical hemostasis in skin grafting. METHODS: The study involved a prospective evaluation of changes in viral titers in patients with burns less than 15% after treatment with fibrin sealant (human). Each patient served as his/her own control for an unblinded, randomized comparison of donor site hemostasis and healing. Preoperative serum was obtained to screen for viral titers. At autografting, the recipient site and one of two randomly chosen donor sites were treated with fibrin sealant (human). The use of other hemostatic agents, including epinephrine was prohibited. Each donor site was covered with gauze to collect blood for estimation of the relative amount of bleeding. The healing of the graft and donor sites was observed. Viral titers and wounds were checked monthly for 6 months, and at 9 and 12 months postoperatively. RESULTS: Viral titers for human immunodeficiency virus; hepatitis A, B, and C; Epstein-Barr virus; and cytomegalovirus were obtained before and after treatment. Of 47 patients, 34 completed the full year of observation. After treatment, there were no seroconversions to any of the aforementioned viruses. Bleeding at the recipient site appeared well controlled with fibrin sealant (human). Although investigators felt that fibrin sealant (human) improved donor site hemostasis, differences in hemoglobin measurements of blood-soaked dressings failed to reach significance. No differences were noted with regard to acceleration of donor site healing, graft take, or scar maturation at the two groups of donor sites. Anecdotally, the maturation of the recipient site appeared to be accelerated. CONCLUSION: Fibrin sealant (human) is safe for use during excision and grafting, and its topical hemostatic potential needs to be examined in patients with larger burns. Its role in scar maturation also needs to be investigated.     

Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients

OBJECTIVE: To evaluate the efficacy, amount of hemorrhage, biliary leakage, complications, and postoperative evolution after fibrin glue sealant application in patients undergoing liver resection. SUMMARY BACKGROUND DATA: Fibrin sealants have become popular as a means of improving perioperative hemostasis and reducing biliary leakage after liver surgery. However, trials regarding its use in liver surgery remain limited and of poor methodologic quality. PATIENTS AND METHODS: A total of 300 patients undergoing hepatic resection were randomly assigned to fibrin glue application or control groups. Characteristics and debit of drainage and postoperative complications were evaluated. The amount of blood loss, measurements of hematologic parameters liver test, and postoperative evolution (particularly involving biliary fistula and morbidity) was also recorded. RESULTS: Postoperatively, no differences were observed in the amount of transfusion (0.15 +/- 0.66 vs. 0.17 +/- 0.63 PRCU; P = 0.7234) or in the patients that required transfusion (18% vs. 12%; P = 0.2), respectively, for the fibrin glue or control group. There were no differences in overall drainage volumes (1180 +/- 2528 vs. 960 +/- 1253 mL) or in days of postoperative drainage (7.9 +/- 5 vs. 7.1 +/- 4.7). Incidence of biliary fistula was similar in the fibrin glue and control groups, (10% vs. 11%). There were no differences regarding postoperative morbidity between groups (23% vs. 23%; P = 1). CONCLUSIONS: Application of fibrin sealant in the raw surface of the liver does not seem justified. Blood loss, transfusion, incidence of biliary fistula, and outcome are comparable to patients without fibrin glue. Therefore, discontinuation of routine use of fibrin sealant would result in significant cost saving.     

Fibrin solutions to control hemorrhage in the trauma patient

Fibrin sealant has been used by a variety of surgical subspecialties as a biological adhesive, sealant, and hemostatic agent. The advantages of these fibrin solutions make them ideal adjunctive hemostatic agents for patients with intra-abdominal solid organ injury. Control of hemorrhage from large stellate wounds of the liver and splenic salvage has been documented in the literature by surgeons from Europe and the United States. Due to the unavailability of a commercial product, surgeons in the United States have had to rely on blood bank-produced fibrin sealant. The purpose of this review is to describe research directed towards developing and evaluating fibrin solutions, both commercial and blood bank-produced, for hemostasis of injuries to the liver and spleen.     

Effectiveness of second-generation fibrin glue in endonasal operations.

We evaluated the efficacy and safety of the Quixil fibrin sealant after its application to endonasal operative sites. A total of 153 patients underwent nasal surgery. The rate of hemorrhagic complications was compared in the group with nasal packing and in the group in whom fibrin glue was used to stop postoperative bleeding. Our results indicate that the application of Quixil fibrin glue to the operative sites in various endonasal operations provides effective hemostasis and sealing. This fibrin glue is a more effective hemostatic agent than foam nasal packing and provides no complications, as can occur with packing. Patients with hypertension have no greater risk for postoperative bleeding if Quixil is used.     

Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop® compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study,NCT00918619)

Background

Despite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection.

Methods

Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period.

Results

A total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [?6.0 %, 19.8 %] does not include the lower noninferiority margin (?10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups.

Conclusion

The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.     

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 Fibrin Sealant in Neck Contouring

Background: The “suture suspension” platysmaplasty technique has been shown to be an effective and reliable procedure over the last decade. Objective: We investigated the effectiveness of fibrin sealant in reducing the recovery time after suture suspension platysmaplasty. Methods: After contouring the neck with our standard suture sling, hemostasis was assured. The instruments and gloves were wet with saline to prevent adherence to the sealant once it was applied. The 2 syringes were mounted on a Duploject applicator. The fibrin sealant was then sprayed simultaneously into the pockets in thin layers for 60 seconds, the time required for the liquid sealant to activate. Gentle manual pressure was applied over the neck skin, with the surgeon's fingers spread evenly over the whole neck, to prevent pooling of the fibrin sealant in any given area. This pressure was applied for 3 minutes, the time required for the tissue fibrin sealant to solidify. The incisions were closed in a standard fashion. Paper tape was used to cover the neck, and dressings were placed. Results: In 60 patients who underwent neck contouring with lipoplasty and suture suspension and lipoplasty with fibrin sealant between January and July 2001, the time necessary to return to activities of daily living was reduced from 7 to 10 days to 2 to 3 days by the use of fibrin sealant. No complications were reported. Conclusions: The use of fibrin tissue sealant has markedly improved the postoperative course of patients who underwent the neck suture suspension procedure by both eliminating most potential complications and decreasing recovery time. (Aesthetic Surg J 2002;22:519-525.)     

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.     

Hemostatic efficacy of latest-generation fibrin sealant after hepatic resection: a randomized controlled clinical study

Purpose

This randomized, controlled, single-blinded multicenter study evaluated the efficacy of latest-generation fibrin sealant containing synthetic aprotinin as fibrinolysis inhibitor as supportive treatment for hemostasis after elective partial hepatectomy.

Methods

Adult subjects undergoing resection of at least one liver segment were assigned to treatment with fibrin sealant or manual compression with a surgical gauze swab if persistent oozing necessitated additional hemostatic measures after primary control of arterial and venous bleeding. The primary outcome measure was the proportion of subjects with intraoperative hemostasis at 4 min after start of randomized treatment application. Secondary efficacy outcome measures included intraoperative hemostasis at 6, 8, and 10 min, intra- and postoperative rebleedings, transfusion requirements, and drainage volume.

Results

Seventy subjects were randomized. Hemostasis at 4 min was achieved in 29/35 (82.9 %) fibrin sealant subjects compared with 13/35 (37.1 %) control subjects (p?p?p?=?0.028), and 10 min (p?=?0.017). The number of rebleedings was low in both study arms. Transfusion requirements and 48-h drainage volumes were similar between the study arms. No adverse events related to study treatment were reported.

Conclusions

Fibrin sealant was shown to be safe and superior to manual compression in the control of parenchymal bleeding after hepatic resection. The use of synthetic aprotinin as fibrinolysis inhibitor further improves the safety margin of fibrin sealant by eliminating the risk of transmission of bovine spongiform encephalopathy and other bovine pathogens.     

Hemostatic efficacy of two advanced dressings in an aortic hemorrhage model in Swine

BACKGROUND: An effective hemostatic agent capable of stopping severe arterial bleeding and sustaining hemostasis over a prolonged time is required. The U.S. Army recently distributed fibrin sealant (under an Investigational New Drug-approved protocol) and chitosan dressings among deployed medics for treating severe external hemorrhage on the battlefield. The purpose of this study was to evaluate the efficacy of these dressings, as compared with the standard gauze army field dressing, to provide initial and sustained hemostasis up to 96 hours in a lethal uncontrolled arterial hemorrhage model. METHODS: Anesthetized pigs were splenectomized and chronically instrumented for fluid/drug administration and continuous monitoring of vital signs. An infrarenal aortotomy was created using a 4.4-mm aortic hole punch and free bleeding was allowed for 5 seconds. While bleeding profusely, a dressing was applied and pressed into the wound for 4 minutes (occluding the distal flow) and then released. If hemostasis was not obtained, the dressing was replaced with a new one (maximum, two dressings per experiment) with another 4-minute compression. If hemostasis was achieved, the abdomen was closed; the animal was then recovered and monitored up to 96 hours. Initial hemostasis, duration of hemostasis, survival time, blood loss, and other variables were measured. RESULTS: Application of army field dressing (gauze) did not stop the arterial hemorrhage and led to exsanguination of all the pigs (n = 6) within 10 to 15 minutes of the injury. Chitosan dressing produced initial hemostasis in five of seven pigs. However, the dressings failed to maintain hemostasis for more than 1.6 hours (range, 28-102 minutes), resulting in secondary bleeding and death of the animals. Fibrin sealant dressing produced initial hemostasis in all the pigs (n = 6) and maintained hemostasis in five cases, with one failure at 2.2 hours. These pigs resumed normal activities and lived for the 96-hour experiment duration. Computed tomographic images and histologic sections of the aortas from surviving fibrin sealant dressing-treated animals showed formation of pseudoaneurysms and early granulation tissue at the aortotomy site. The posttreatment blood loss, duration of hemostasis, and survival time were significantly different in the fibrin sealant dressing group than the chitosan dressing and army field dressing groups. CONCLUSION: Both chitosan dressing and fibrin sealant dressing stopped initial arterial bleeding that could not be controlled by the standard army field dressing. However, although the fibrin sealant dressing secured hemostasis for up to 4 days, the chitosan dressing consistently failed within 2 hours after application. There may be a risk of rebleeding for high-pressure arterial wounds treated with chitosan dressings, particularly in situations where definitive care is delayed substantially.     

Use of Fibrin Sealants in Cardiovascular Surgery: A Systematic Review

Background

Fibrin sealants are used for hemostasis and tissue adherence.

Aim of Study

This systematic review summarizes published clinical data for fibrin sealant use in cardiovascular surgery.

Methods

A literature search for the following terms was conducted using PubMed and EMBASE: (TISSEEL or Tissucol or Beriplast P or Evicel or Quixil or Crosseal or Reliseal or Fibringluraas or Bolheal or Tachosil or Vivostat or Vitagel or Artiss or “fibrin glue” or “fibrin sealant” or “fibrin tissue adhesive”) and (cardiac or cardiovascular or vascular or heart or coronary or surgery). Case reports and series were excluded; although reports of controlled trials were preferred, uncontrolled trial data were also considered.

Results

Clinical trials and chart review analyses of fibrin sealants were identified and summarized. Although clinical trial data were available for other agents, the majority of published studies examined TISSEEL. Overall, TISSEEL and other fibrin sealants showed improvements over standard of care or control groups for a variety of predefined endpoints. Safety findings are also summarized.

Conclusions

Data from these studies showed that fibrin sealants were well tolerated and provided effective hemostasis in a range of cardiac and aortic surgeries. doi: 10.1111/jocs.12099 (J Card Surg 2013;28:238–247)     

Fibrin sealant treatment of splenic injury during open and laparoscopic left radical nephrectomy

PURPOSE: We describe the use of fibrin sealant for rapid and definitive hemostasis of splenic injuries incurred during open and laparoscopic left nephrectomy. MATERIALS AND METHODS: In 2 patients undergoing left nephrectomy for a suspicious renal mass splenic laceration occurred during mobilization of the colonic splenic flexure at open nephrectomy and laparoscopic upper pole dissection, respectively. Fibrin sealant was applied topically in each case. RESULTS: In each patient fibrin sealant achieved immediate hemostasis and each recovered without further splenic bleeding. CONCLUSIONS: The topical application of fibrin sealant safely, rapidly and reliably achieves definitive hemostasis of splenic injuries. It is simple to use in the open and laparoscopic approaches.     

Comparative efficacy of topical hemostatic agents in a rat kidney model.

The efficacies of four topical hemostatic agents were compared in a rat model employing a standardized renal injury. The materials used to effect hemostasis were oxidized cellulose, microfibrillar collagen powder, positively charged modified collagen, and single donor heterologous fibrin glue. Animals that were treated only with surgical gauze served as controls. Hemostasis was achieved by application of one of the topical hemostatic agents plus moderate digital pressure. The time necessary to achieve complete hemostasis was recorded for each animal. Control animals bled profusely and suffered an increased postoperative mortality rate compared with the experimental animals. Microscopic studies demonstrated progressive healing of the injuries with varying degrees of inflammation and scar formation. Fibrin glue was by far the most effective agent in controlling hemostasis. The collagen materials, though effective, required a longer time to control bleeding and did not differ statistically in their activity from one another.     

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.     

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.     

Bleeding from the sternal marrow can be stopped using vivostat patient-derived fibrin sealant

BACKGROUND: Median sternotomy is the most important method of access to the heart. Bleeding from the sternal marrow may become significant, especially in elderly patients. Vivostat (ConvaTec, a Bristol-Myers Squibb Company, Skillman, NJ) patient-derived fibrin sealant is biocompatible and easily applied to the sternal marrow using the Vivostat Spraypen applicator. METHODS: Thirty patients undergoing elective cardiac operation were randomized to receive Vivostat fibrin sealant applied to either the right or left side of the sternum immediately after median sternotomy, with the untreated side serving as control. RESULTS: The average time to hemostasis was 43 seconds after treatment with Vivostat and 180 seconds on the control sides (p<0.001). At the end of the operation, complete hemostasis was observed on 24 of 30 sides treated with Vivostat compared with on 4 of 30 of the control sides (p<0.001). The average volume of sealant used to cover one side of the sternum was 0.9 mL. CONCLUSIONS: Vivostat patient-derived fibrin sealant is a biocompatible alternative to bone wax, with the results of this study showing that it provides effective control of bleeding after median sternotomy.     

A novel approach to closure of perineal wounds during abdominoperineal resection: use of fibrin sealant

Abdominoperineal resection is associated with significant morbidity. The perineal wound poses a unique risk and complications are common, including skin breakdown, abscess, sinus tracts, perineal herniation, and evisceration. A 2-component fibrin sealant made from pooled human plasma has been proven to achieve hemostasis and tissue sealing. We report a case series of 5 consecutive patients in whom we used this fibrin sealant during perineal wound closure. Of our patients, 2 patients (40%) were diabetic and 4 patients (80%) received preoperative radiotherapy. The median body mass index was 32 (calculated as weight in kilograms divided by height in meters squared). The patients were at increased risk of perineal wound dehiscence and infection. Median follow-up was 6 months, and no patients had perineal wound complications. A fibrin sealant could be used as an alternative to more invasive procedures, such as flap reconstruction, in patients at high risk of perineal wound dehiscence.     

Hemostatic effectiveness of fibrin glue derived from single-donor fresh frozen plasma

Fibrin glue derived from pooled human blood is an effective sealant for high-porosity vascular grafts and a valuable topical hemostatic agent in heparinized patients. Use of this agent in the United States is prohibited because of potential transmission of hepatitis B, acquired immunodeficiency syndrome, and other serologically transmitted illnesses. We have developed a cryoprecipitation technique that allows preparation of fibrin glue from single-donor fresh frozen plasma. Use of this agent presumably entails no greater risk of disease transmission than intravenous administration of single-unit fresh frozen plasma. This report describes our early clinical experience with this material. Fibrin glue was used as a sealant for porous woven Dacron tubular prostheses and cardiovascular patches in 19 patients. The fibrin glue sealant has also been employed to control bleeding from needle holes and small anastomotic tears in 22 patients. No patient in this series had a bleeding complication from a suture line or graft treated with fibrin glue. This experience indicates that like fibrin glue from pooled blood, fibrin glue from single-donor plasma is effective as a graft sealant and topical hemostatic agent. Preparation of fibrin glue from single-donor plasma is simple and economical, and may provide cardiothoracic surgeons in the United States with a widely available, valuable hemostatic adjunct.