Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Gelatin–thrombin-based Hemostatic Sealant for Intraoperative Bleeding in Vascular Surgery
 Effective management of bleeding during tumor resection with a collagen-based hemostatic agent. Evaluation of the Hemostatic Effects of Ankaferd Blood Stopper During Dental Extractions in Patients on Antithrombotic Therapy Comparison of the hemostatic effect of endoscopic injection with fibrin glue and hypertonic saline-epinephrine for peptic ulcer bleeding: a prospective randomized trial. A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding. Effective control of hepatic bleeding with a novel collagen-based composite combined with autologous plasma: results of a randomized controlled trial. Control of bleeding in endoscopic sinus surgery: use of a novel gelatin-based hemostatic agent. Prospective, Randomized, Controlled Clinical Trial of a Novel Matrix Hemostatic Sealant in Children Undergoing Adenoidectomy A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. A Randomized Clinical Trial Comparing the Effect of Different Haemostatic Agents for Haemostasis of the Liver after Hepatic Resection Comparison of a new fibrin sealant with standard topical hemostatic agents. Hemostatic effect of tranexamic acid mouthwash in anticoagulant-treated patients undergoing oral surgery. Hemostasis in endoscopic sinus surgery using a specific gelatin-thrombin based agent (FloSeal).
BACKGROUND Topical hemostatic agents composed of a gelatin-based matrix and thrombin have been reported to be effective , in addition to traditional means , in terminating bleeding during cardiac operations . We compared a hemostatic matrix sealant agent ( FloSeal ; Baxter Inc , Deerfield , IL ) with alternative topical hemostatic agents in a mixed cohort of elective cardiac and thoracic aortic operations . METHODS Following sample size calculation , in a prospect i ve r and omized study design , 209 patients were treated with FloSeal matrix sealant ( FloSeal group ) and 206 patients received alternative agents as topical hemostatic material s ( comparison group ) . FloSeal is composed of a self-exp and able gelatin matrix component and purified bovine thrombin . Comparisons included hemostatic patches or sponges composed of either oxidized regenerated cellulose or purified porcine skin gelatin . Study endpoints were the following : rate of successful intraoperative hemostasis ( identified by cessation of bleeding ) and time required for hemostasis ; overall postoperative bleeding ; rate of transfusion of blood products ; rate of surgical revision for bleeding ; postoperative morbidity ; and intensive care unit stay . RESULTS Statistically higher rates of successful hemostasis and shorter time-to-hemostasis were observed in the FloSeal group ( p < 0.001 both ) . Time-to-event analysis confirmed this finding ( p = 0.0025 ) . Postoperative bleeding and rate of transfusion of blood products were statistically decreased in the FloSeal group ( p < 0.001 both ) . Rates of revision for bleeding and of minor complications were not statistically different among groups in the overall cohort , but were significantly lesser in the FloSeal group if only patients with overt intraoperative bleeding are considered ( p = 0.04 both ) . The advantages observed in the FloSeal group were not offset in patients undergoing systemic hypothermia . CONCLUSIONS The topical hemostatic agent used in the FloSeal group is effective in terminating intraoperative bleeding as an adjunct to traditional surgical methods for stopping bleeding . Its judicious use is associated with lesser need for transfusion of blood products and rate of revision for bleeding . Its cost-utility profile should be addressed in dedicated trials Vascular surgical procedures may be prolonged because of intraoperative bleeding that is not easily controlled by cautery or suture ligation . This trial compared the ability of a new hemostat , FloSealTM Matrix ( FM ) , with a known hemostat , Gelfoam ® plus thrombin ( GT ) , to control intraoperative bleeding . Patients undergoing vascular surgery procedures at four institutions were entered in the trial . After a bleeding site was identified , patients were r and omized to one of the study agents : ( 1 ) FM , a cross-linked gelatin of bovine origin combined with thrombin , or ( 2 ) GT . The assigned agent was applied and the site observed for bleeding at 1 , 2 , 3 , 6 , and 10 min . The primary end point was cessation of bleeding within 10 min for the first identified site treated . Secondary end points were cessation of bleeding within 10 min for all sites and time to cessation of bleeding . Patients were assessed for morbidity at 30 days and 6 - 8 weeks after the operation . Analysis was performed on an intent-to-treat basis for analysis of hemostasis at 10 min and on protocol -valid patients for analysis of time to hemostasis . From our results we concluded that for patients undergoing vascular surgery procedures , the new topical hemostat , FloSeal Matrix , provides more rapid and effective hemostasis than Gelfoam plus thrombin In a prospect i ve controlled trial hemostatic effectiveness of a novel collagen-based composite ( CoStasis ) was compared with a collagen sponge applied with manual pressure at diffusely bleeding sites after surgical tumor resection .  The proportion of subjects achieving complete cessation of bleeding within 10 minutes ( i.e. , hemostatic success ) and the time to " complete hemostasis " were determined at raw surgical sites after tumor resection among 23 experimental and 30 control subjects . There was a similar distribution in tumor types ( e.g. , benign vs malignant ) evaluated between treatment groups . A significantly greater proportion of experimental subjects achieved complete hemostasis within 10 minutes of observation compared with controls [ 23 of 23 ( 100 % ) vs 21 of 30 ( 70 % ) ; P = 0.003 ] . The median time required to achieve complete hemostasis was more than three times longer for subjects treated with the collagen sponge compared with subjects treated with CoStasis ( 243 vs 78 seconds ; P = 0.0001 ) . Approximately 80 per cent of experimental subjects achieved complete hemostasis within 2 minutes compared with only 35 per cent of controls . There were no adverse events related to the experimental treatment in this study . These results support the use of this novel hemostatic agent to control diffuse surgical site bleeding  after tumor resection at diverse anatomical locations This study evaluated the early hemostatic effects of a novel hemostatic agent ( Ankaferd blood stopper [ ABS ] ) during dental extraction s in patients on antithrombotic therapy  , without interruption or diminution of the medication . In total , 25 patients , who are on antithrombotic therapy and in need of simple dental extraction s , were r and omized into 2 groups . In group I ( control group ) , which consisted of 10 patients , local hemostasis was achieved with direct packing with gauze . In group II , which consisted of 15 patients , local hemostasis was achieved by the local application of ABS on the extraction sockets . The bleeding time was compared between 2 groups following the tooth extraction . The bleeding time in the dental sockets treated with ABS was statistically lower compared to the sockets of the control group ( p = 0.0001 ) . It is concluded that the dental extraction s could be performed without interruption of the medication in patients on antithrombotic therapy . The ABS appears to be sufficient as an alternative hemostatic agent BACKGROUND AND STUDY AIMS Although endoscopic injection therapy using various agents has been considered the least expensive and most effective technique in obtaining hemostasis in peptic ulcer bleeding , most of these agents induce tissue necrosis or degeneration . Theoretically the injection of fibrin glue ( FG ) to halt peptic ulcer bleeding may be safer than the use of other agents , but r and omized clinical trials to compare the efficacy of FG and other agents are rare . The aim of this study was to compare the hemostatic efficacy between FG and hypertonic saline-epinephrine ( HSE ) in peptic ulcer bleeding . PATIENTS AND METHODS From March 1992 to December 1993 we conducted a prospect i ve r and omized trial in 127 patients with peptic ulcer bleeding , in whom a visible vessel or active bleeding was identified . Patients were r and omized into two groups , an FG group comprising 64 patients who received FG injections , and an HSE group , comprising 63 patients who received HSE injections . RESULTS The two groups were comparable with regard to age , sex , bleeding focus and bleeding stigma . Permanent hemostasis using only endoscopic treatment was achieved in 59 cases ( 92.2 % ) in the FG group and in 54 cases ( 85.7 % ) in the HSE group . Rebleeding occurred in seven cases ( 10.9 % ) in the FG group and in 14 cases ( 22.2 % ) in the HSE group ( P=0.087 ) ; emergency surgery was undertaken in four ( 6.3 % ) and seven cases ( 11.1 % ) , respectively ( P = 0.33 ) ; death occurred in one case ( 1.6 % ) and four cases ( 6.3 % ) , respectively ( P = 0.165 ) . CONCLUSIONS These results suggest that endoscopic injection of FG is an effective method in the control of peptic ulcer bleeding . However , even though there is a strong trend supporting the hypothesis that fibrin glue is superior to HSE , no statistically significant differences are noted . A trial involving larger numbers may produce a positive result BACKGROUND Periodontal plastic surgery has increased the use of palatal wounds for donor tissue , with the most common complication being excessive bleeding from the palate after harvesting tissue . This study was conducted to evaluate the efficacy of 3 methods for achieving hemostasis on the palate after harvesting donor tissue for autogenous soft tissue grafts . METHODS Thirty sites were evaluated at surgery for hemostasis and followed over 21 days for healing and adverse events . Three treatment groups were r and omly selected and patients received either a test product or control comprising : 1 ) oxidized regenerated cellulose ; 2 ) absorbable gelatin sponge ; or 3 ) sterile gauze with external pressure as the control .  All patients received a surgical stent for the palate .  RESULTS The results were analyzed for smokers and non-smokers , and the median time to hemostasis was significantly shorter when a hemostatic agent was applied to the palatal wounds compared to controls in both groups . Pain assessment showed no differences across treatment groups . However , by 21 days , only the oxidized regenerated cellulose group had complete healing based on blinded clinical evaluation with all sites rated as normal to rapid healing , compared to the absorbable gelatin sponge group where 40 % of the sites were rated as slow healing . Adverse events , primarily bleeding episodes during the first 7 days after surgery , were found in 40 % of the oxidized regenerated cellulose and gauze control groups , while no sites in the absorbable gelatin sponge group had an adverse event . The patients were followed for an average of 10 months and demonstrated a mean shrinkage of their recipient grafts of 24 % in total surface area . CONCLUSIONS This study concluded that the use of hemostatic agents for palatal wounds is confirmed as the treatment of choice when performing free soft tissue grafts HYPOTHESIS A novel collagen-based composite of bovine microfibrillar collagen and bovine thrombin combined with autologous plasma is more effective than st and ard hemostasis ( collagen sponge applied with pressure ) in controlling diffuse hepatic bleeding  after hemihepatectomy or segmental resection of the liver . DESIGN R and omized controlled trial . SETTING Seven university-affiliated medical centers . PATIENTS Sixty-seven adult patients scheduled for hemihepatectomy or segmental resection who received hemostatic intervention with an investigational treatment ( n = 38 ) or control ( n = 29 ) . INTERVENTION Bleeding hepatic tissue was managed in all control subjects with a collagen sponge with manual pressure . Subjects in the experimental group had the sprayable liquid composite intraoperatively applied to the surgical site . The liquid immediately formed a collagen-fibrin gel that was used without concomitant tamponade . MAIN OUTCOME MEASURES Hemostatic success was defined as the proportion of subjects in each treatment group who achieved complete hemostasis within 10 minutes . Success rates and median times required to achieve controlled bleeding ( ie , slight oozing ) and complete hemostasis were compared between treatment groups . RESULTS All 38 subjects in the experimental group achieved complete hemostasis within 10 minutes compared with only 69 % ( 20/29 ) of control subjects ( P<.001 ) . The median time to controlled bleeding was approximately 4 times longer ( 250 vs 62 seconds ) for control subjects than for experimental group subjects ( P<.001 ) . The median time required to achieve complete hemostasis also favored the experimental group ( 150 vs 360 seconds ; P<.001 ) . No adverse events related to the use of the experimental hemostatic agent were detected . CONCLUSIONS The experimental composite is more effective at controlling and stopping diffuse hepatic bleeding than a collagen sponge applied with pressure ; it may be a useful hemostatic agent for patients undergoing hemihepatectomy , segmental resection , and related surgical procedures OBJECTIVE To determine whether FloSeal Matrix Hemostatic Sealant is a safe and effective means of controlling bleeding  post-endoscopic sinus surgery ( ESS ) and to assess postoperative healing . DESIGN Prospect i ve clinical study . SETTING University of Toronto . METHODS Eighteen patients with FloSeal placed on a total of 30 operative sites post-ESS .  Time to cessation of bleeding was assessed intraoperatively . Patients had the operative sites assessed at 30 days postoperatively . MAIN OUTCOME MEASURES Effectiveness of FloSeal in controlling bleeding and aiding in healing of the operative site . RESULTS FloSeal adequately controls postoperative bleeding in patients post-ESS .  Healing was also not adversely affected . CONCLUSIONS FloSeal is a safe and effective treatment for controlling blood loss after EES . It may also provide support to the middle meatus as well as improve healing of the operative site compared with the use of traditional nasal packing . However , r and omized clinical trials are needed to further evaluate this 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 clinical ly proven to control bleeding . This study is a prospect i ve , r and omized , 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 r and omized 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 question ed 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 $ 85 . Operating room costs are estimated at $ 12/minute . Reducing the operative length by 8.9 minutes on average produces a cost savings of $ 106.80 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 The development of inhibitory antibodies to factor VIII is a serious complication of hemophilia .  FEIBA ( factor VIII inhibitor-bypassing activity ) , an activated prothrombin complex concentrate ( aPCC ) , and NovoSeven , recombinant factor VIIa ( rFVIIa ) , are used as hemostatic bypassing agents in treating patients with inhibitors . The FENOC study was design ed to test equivalence of the products in the treatment of ankle , knee , and elbow joint bleeding . A prospect i ve , open-label , r and omized , crossover , equivalency design was used . The parameters of interest were the percentage of patients who reported efficacy in response to FEIBA and the percentage that reported efficacy in response to NovoSeven . A difference in these percentages of no more than 15 % was determined to be a clinical ly acceptable magnitude for equivalence of the 2 products . The primary outcome was evaluation 6 hours after treatment .  Data for 96 bleeding episodes contributed by 48 participants were analyzed . The criterion for declaring the 2 products equivalent at 6 hours was not met ; however , the confidence interval of the difference in percentages of efficacy reported for each product only slightly exceeded the 15 % boundary ( -11.4%-15.7 % ) , P=.059 . FEIBA and NovoSeven appear to exhibit a similar effect on joint bleeds , although the efficacy between products is rated differently by a substantial proportion of patients . This trial was registered at www . clinical trials.gov as # NCT00166309 Introduction . Operative blood loss is still a great obstacle to liver resection , and various topical hemostatic agents were introduced to reduce it . The aim of the current study is to evaluate effects of 3 different types of these agents . Methods . In this r and omized clinical trial , 45 patients undergoing liver resection were assigned to receive TachoSil , Surgicel , and Glubran 2 for controlling bleeding . Intraoperative and postoperative findings were compared between groups . Results . Postoperative bleeding ( 0 versus 33.3 % , P = 0.04 ) and drainage volume first day after surgery ( 281.33 ± 103.98 versus 150.00 ± 60.82 mL , P = 0.02 ) were significantly higher in Surgicel than in TachoSil group . Postoperative complications included bile leak ( 3 cases in Surgicel , 1 case in TachoSil and Glubran 2 ) , noninfectious collection ( 2 cases in TachoSil and Surgicel and 1 case in Glubran 2 ) , perihepatic abscess , and massive hematoma around hepatectomy site both in Surgicel group . There was no death during the study period . Conclusion . Due to higher complications in Surgicel group , its application as hemostatic agent after liver resection is not recommended . Better results in TachoSil in comparison to the other two are indicative of its better efficacy and superiority in controlling hemostasis BACKGROUND Bleeding following liver resection continues to be a significant morbidity of the procedure . Fibrin sealants represent an improvement over conventional topical hemostatic agents , because they contain components that actively form clot . However , most available agents contain nonhuman protein , which represents an immunologic risk . HYPOTHESIS An investigational surgical fibrin sealant ( Crosseal ; American Red Cross , Washington , DC ) composed of human clottable proteins and human thrombin is more effective than st and ard topical hemostatic agents in reducing the time required to achieve hemostasis after liver resection . DESIGN Prospect i ve , r and omized , controlled trial . SETTING Fifteen major referral centers in the United States and the United Kingdom . METHODS After liver resection using st and ard surgical techniques , 121 patients seen between May 1999 and May 2000 were r and omized to treatment with a 2-component fibrin sealant ( n=58 ) or to st and ard topical hemostatic agents , used singly or in combination ( n=63 ) . Up to 10 mL of Crosseal was administered by a spray applicator , as recommended by the manufacturer , whereas agents used in the control group were applied according to their instructions for use . MAIN OUTCOME MEASURES The primary outcome measured was time to hemostasis . Secondary outcomes measured included blood loss between application of the hemostatic agent and closure of the abdomen , duration of postoperative biliary drainage , and the occurrence of complications , defined a priori as reoperation for any reason , development of abdominal fluid collection s , or bilious appearance of drained fluid for at least 1 day postoperatively . RESULTS The mean time to hemostasis was 282 seconds with Crosseal , compared with 468 seconds with st and ard agents ( 2-sided ; P = .06 ) , for the 116 efficacy-evaluable patients .  Hemostasis was achieved within 10 minutes in 53 patients ( 91.4 % ) treated with the study fibrin sealant and in 44 control patients ( 69.8 % ) ( 2-sided ; P = .003 ) . Intraoperative blood loss was similar in the 2 groups . In the Crosseal group , the percentage of patients developing postoperative complications was 17.2 % , compared with 36.5 % in the control group ( 2-sided ; P = .02 ) . CONCLUSIONS Compared with the use of st and ard topical hemostatic agents , Crosseal fibrin sealant significantly reduced the time to achieve hemostasis following liver resection . Patients treated with the new fibrin sealant also experienced significantly fewer postoperative complications We carried out a placebo-controlled , double-blind , r and omized study of the hemostatic effect of tranexamic acid mouthwash after oral surgery in 39 patients receiving anticoagulant agents because of the presence of cardiac valvular stenosis , a prosthetic cardiac valve , or a vascular prosthesis . Surgery was performed with no change in the level of anticoagulant therapy , and treatment with the anticoagulant agent was continued after surgery . Before it was sutured , the operative field was irrigated in 19 patients with 10 ml of a 4.8 percent aqueous solution of tranexamic acid ( an inhibitor of fibrinolysis ) and in 20 patients with a placebo solution . For seven days thereafter , patients were instructed to rinse their mouths with 10 ml of the assigned solution for two minutes four times a day . There were no significant differences between the two treatment groups in base-line variables , including the level of anticoagulation at the time of surgery . Eight patients in the placebo group had a total of 10 postoperative bleeding episodes , whereas only 1 patient in the tranexamic acid group had a bleeding episode ( P = 0.01 ) . There were no systemic side effects . We conclude that local antifibrinolytic therapy is effective in preventing bleeding after oral surgery in patients who are being treated with anticoagulants The safety and efficacy of a new hemostatic sealant , based on a gel with collagen derived particles and topical thrombin ( FloSeal , Fusion Medical Technologies , Inc. Fremont , CA ) were assessed as an alternative to nasal packing for hemostasis in functional endoscopic sinus surgery . In a prospect i ve clinical study of 50 patients undergoing bilateral endoscopic anterior ethmoidectomy  , 2 ml FloSeal was used after surgery to stop bleeding . The results were compared to a control group of 50 patients with Merocel packing  and showed that intraoperative hemostasis was rapid and equal in both groups . The main advantages of the new hemostatic sealant included a higher degree of comfort during postoperative nasal breathing and absence of complaints due to pressure or pain . There was only one case of postoperative bleeding on the 6th day , which required nasal packing . There were no more cases of stenoses or synechia in the ostiomeatal complex than were found in the Merocel group . No systemic side effects due to FloSeal were observed . This specific hemostatic sealant was shown to be a safe and efficacious alternative method for hemostasis in endoscopic sinus surgery with high patient satisfaction and an easy and fast mode of application
Scanning electron microscopy revealed partial removal of the smear layer or an etching effect of dentin as a result of the application of hemostatic agents on dentin .
PRACTICAL IMPLICATION S Adhesive procedures may be affected adversely when performed on dentin and enamel contaminated by hemostatic agents .
Hemostatic agents may induce changes in the dentin surface morphology .
The results of this review indicate that the bond strength of self-etching adhesive systems is affected more negatively than is that of etch- and -rinse systems .
BACKGROUND Hemostatic agents have been used clinical ly in dentistry for many years to control bleeding .