Autologous Fibrin Sealant Research Articles

Autologous fibrin sealant (Vivostat®) in the neurosurgical practice: Part I: Intracranial surgical procedure

Background:Hemorrhages, cerebrospinal fluid (CSF) fistula and infections are the most challenging postoperative complications in Neurosurgery. In this study, we report our preliminary results using a fully autologous fibrin sealant agent, the Vivostat® system, in achieving hemostasis and CSF leakage repair during cranio-cerebral procedures.Methods:From January 2012 to March 2014, 77 patients were studied prospectively and data were collected and analyzed. Autologous fibrin sealant, taken from patient's blood, was prepared with the Vivostat® system and applied on the resection bed or above the dura mater to achieve hemostasis and dural sealing. The surgical technique, time to bleeding control and associated complications were recorded.Results:A total of 79 neurosurgical procedures have been performed on 77 patients. In the majority of cases (98%) the same autologous fibrin glue provided rapid hemostasis and dural sealing. No patient developed allergic reactions or systemic complications in association with its application. There were no cases of cerebral hematoma, swelling, infection, or epileptic seizures after surgery whether in the immediate or in late period follow-up.Conclusions:In this preliminary study, the easy and direct application of autologous fibrin sealant agent helped in controlling cerebral bleeding and in providing prompt and efficient dural sealing with resolution of CSF leaks. Although the use of autologous fibrin glue seems to be safe, easy, and effective, further investigations are strongly recommended to quantify real advantages and potential limitations.

Erratum to: Incidence of Gastrojejunostomy Stricture in Laparoscopic Roux-en-Y Gastric Bypass Using an Autologous Fibrin Sealant

Erratum to: Incidence of Gastrojejunostomy Stricture in Laparoscopic Roux-en-Y Gastric Bypass Using an Autologous Fibrin Sealant

Vivostat®: an autologous fibrin sealant as useful adjunct in endoscopic transnasal CSF-leak repair

The benefit of fibrin glue for reduction of postoperative CSF-leaks after endoscopic skull base surgery is not clearly evident in literature. However, its use is supposed to be beneficial in fixing grafting material. As of today there is no specific data available for otolaryngological procedures. A retrospective data analysis at a tertiary care referral center on 73 patients treated endoscopically transnasally for CSF-leaks at the ENT-department Graz between 2009 and 2012 was performed. Primary closure rate between conventional fibrin glue and autologous fibrin glue were analyzed. The Vivostat(®) system was used in 33 CSF-leak closures and in 40 cases conventional fibrin glue was used. Comparing the two methods the primary closure rate using the autologous Vivostat(®) system was 75.8 and 85.0 % with conventional fibrin glue. The secondary closure the rates were 90.9 % with Vivostat(®) 92.5 % with conventional fibrin glue. The Vivosat(®) system is a useful adjunct in endoscopic CSF-leak closure. Its advantages over conventional fibrin glue are its application system for fixation of grafting material particularly in underlay techniques. Despite this advantage it cannot replace grafting material or is a substitute for proper endoscopic closure which is reflected by the closure rates.

Current State and Use of Biological Adhesives in Orthopedic Surgery

Bone and tissue adhesives are common and beneficial supplements to standard methods of musculoskeletal tissue suture repair. Knowledge and development of biologically derived or inspired adhesives useful in orthopedic surgery are rapidly advancing. Recent literature demonstrates the increased adjunct or primary use of biological adhesives in the repair of musculoskeletal soft tissues, chondral fractures, and osteochondral fractures. Adhesives offer more benefits and enhancements to tissue healing than current fixation methods afford, including improved biocompatibility, resorbability, and non-immunogenicity. Further investigation is required to determine the extent of the role that these bioadhesives can play in orthopedic surgery. The largest group of biologically derived adhesives and sealants is fibrin sealants, which include first- and second-generation commercially available fibrin sealants, autologous fibrin sealants, and variants. Other groups include gelatin-resorcin aldehydes, protein-aldehyde systems, collagen-based adhesives, polysaccharide- based adhesives, mussel adhesive proteins, and various biologically inspired or biomimetic glues. Potential uses include applications in orthopedic-related blood conservation, arthroplasty, articular cartilage disorders, sports medicine, spine surgery, trauma, and tumors. The development of an adhesive with universal application is likely unfeasible, given the unique characteristics of various musculoskeletal tissues. However, the literature demonstrates the overall underuse of adhesives and indicates the rising probability of the development of a successful variety of bioadhesives for use in orthopedic surgery. As a result of reading this article, physicians should be able to: 1. Describe the difference between adhesives and sealants. 2. Recognize fibrin adhesives commonly used in practice today and identify other biological adhesives with rising potential. 3. Analyze how fibrin sealants work relative to fibrin and fibrinogen. 4. Identify anatomical areas and techniques in which fibrin sealants are used.

Autologous or heterologous fibrin sealant scaffold: which is the better choice?

Univ Estadual Paulista, Ctr Study Venoms & Venomous Anim CEVAP, BR-18610307 Botucatu, SP, Brazil

Current State and Use of Biological Adhesives in Orthopedic Surgery

Bone and tissue adhesives are common and beneficial supplements to standard methods of musculoskeletal tissue suture repair. Knowledge and development of biologically derived or inspired adhesives useful in orthopedic surgery are rapidly advancing. Recent literature demonstrates the increased adjunct or primary use of biological adhesives in the repair of musculoskeletal soft tissues, chondral fractures, and osteochondral fractures. Adhesives offer more benefits and enhancements to tissue healing than current fixation methods afford, including improved biocompatibility, resorbability, and non-immunogenicity. Further investigation is required to determine the extent of the role that these bioadhesives can play in orthopedic surgery. The largest group of biologically derived adhesives and sealants is fibrin sealants, which include first- and second-generation commercially available fibrin sealants, autologous fibrin sealants, and variants. Other groups include gelatin-resorcin aldehydes, protein-aldehyde systems, collagen-based adhesives, polysaccharide- based adhesives, mussel adhesive proteins, and various biologically inspired or biomimetic glues. Potential uses include applications in orthopedic-related blood conservation, arthroplasty, articular cartilage disorders, sports medicine, spine surgery, trauma, and tumors. The development of an adhesive with universal application is likely unfeasible, given the unique characteristics of various musculoskeletal tissues. However, the literature demonstrates the overall underuse of adhesives and indicates the rising probability of the development of a successful variety of bioadhesives for use in orthopedic surgery. As a result of reading this article, physicians should be able to: 1. Describe the difference between adhesives and sealants. 2. Recognize fibrin adhesives commonly used in practice today and identify other biological adhesives with rising potential. 3. Analyze how fibrin sealants work relative to fibrin and fibrinogen. 4. Identify anatomical areas and techniques in which fibrin sealants are used.

Fistula Fiberscope–assisted Percutaneous Glue Sealing for Enterocutaneous Fistulas

Endoscopic therapy is a valuable option for glue sealing in fistula patients with low-output volume to enable more complete filling of internal openings. However, no special endoscopes were designed and made for fistula tracts. This brief report concerns about the application of an autologous platelet-rich fibrin sealant through a refined fistula fiberscope. Symptoms achieved resolutions and the follow-up computed tomography scans revealed no intestinal fluid leakage. To our knowledge, this is the first report on this percutaneous endoscope-assisted glue procedure.

Autologous fibrin sealant in tubeless percutaneous nephrolithotomy; a prospective study.

To evaluate the efficacy of autologous single-donor fibrin glue after tubeless percutaneous nephrolithotomy (PCNL). Forty-three patients were planned for tubeless PCNL in a prospective cohort study and randomized in two groups with or without using fibrin glue. Randomization method was based on the computer-generated random numbers. Transfusion, urinary leakage, or major complications were found in neither of the groups. There was no difference between two groups in stone free rate (P = .53), and changes in hemoglobin (P = .61) and serum creatinine (P = .63) level. Although autologous fibrin glue did not play any significant role in improving results or decreasing complications after tubeless PCNL in our study, its use was safe and did not increase complications.

Fibrin sealant and lipoabdominoplasty in obese grade 1 and 2 patients.

BackgroundEver since lipoabdominoplasty was first developed to achieve better aesthetic outcomes and less morbidity, the rate of seroma formation, especially in obese patients, has disturbed plastic surgeons. The aim of this study was to evaluate the effect of fibrin sealant in the prevention of seroma formation after lipoabdominoplasty in obese patients.MethodsSixty patients with a body mass index (BMI) between 30 and 39.9 were assigned randomly to 1 of 2 groups (30 patients each). Group A underwent lipoabdominoplasty with fibrin glue, while group B underwent traditional lipoabdominoplasty; both had closed suction drainage applied to the abdomen. The patients' demographics and postoperative complications were recorded. Seroma was detected using abdominal ultrasound examinations at two postoperative periods: between postoperative days 10 and 12 and, between postoperative days 18 and 21.ResultsThe age range was 31 to 55 years (38.5±9.5 years) in group A and 25 to 58 years (37.8±9.1 years) in group B, while the mean BMI was 31.4 to 39.9 kg/m2 (32.6 kg/m2) in group A and 32.7 to 37.4 kg/m2 (31.5 kg/m2) in group B. In group A, the patients had a complication rate of 10% in group A versus 43% in group B (P<0.05). The incidence of seroma formation was 3% in the fibrin glue group but 37% in the lipoabdominoplasty-alone group (P<0.05).ConclusionsLipoabdominoplasty with the use of autologous fibrin sealant is a very effective method that significantly reduces the rate of postoperative seroma.

Using an autologous fibrin sealant in the preventing of cerebrospinal fluid leak with large skull base defect following endoscopic endonasal transsphenoidal surgery

Postoperative cerebrospinal fluid (CSF) leak following endoscopic endonasal transsphenoidal surgery (EETS) is associated with increased morbidity and mortality. This prospective study is the first evaluation of using autologous fibrin sealant for preventing postoperative CSF leak and related complications. 200 endoscopic endonasal transsphenoidal approaches were included in the study and reviewed retrospectively from September 2010 to June 2012. A total of 55 patients who have large skull base and diafragma sella defects, connected with basal cisterns or ventricles, were chosen for the study. The patients were operated via extended or classical endoscopic endonasal transsphenoidal approach. The skull base has been repaired using AFS combined with multilayer reconstruction in all cases. The incidence of CSF leak as a complication of EETS was analyzed. The ages of the patients ranged from 20 to 83 years (mean 49.3 years). There were 25 (46%) male patients and 30 (54%) females. All patients had tumors with suprasellar or parasellar extension. Postoperative CSF leak was determined in 2 patients (3.6%). There were no complications and allergic reactions associated with the use of AFS. Using of AFS combined with multilayer reconstruction technique is a safe and effective method to prevent CSF leak in large defects following EETS.

Haemostasis control during laparoscopic partial nephrectomy without parenchymal renorrhaphy: The Vivostat® experience

ObjectiveTo present our experience using an autologous fibrin sealant prepared with the Vivostat system® to control haemostasis without any renal parenchymal reconstruction. Material and methodsWe performed 45 laparoscopic partial nephrectomies using this haemostatic agent. The surgical steps were: colon mobilization, identification of ureter, renal vessels and renal tumor, renal artery control with Rummel tourniquet, tumor excision with harmonic scalpel, and application of fibrin glue to the resection bed twice (before and after kidney reperfusion). Patients were evaluated for acute or delayed bleeding. ResultsMean age was 63.9 years (33–80); mean tumor size was 2.5cm (1.5–4); mean operative time was 136.1min (90–180). Mean warm ischemia time was 19.2min (10–30). Mean blood loss was 97ml (50–300). Individual haemostatic stitches were performed before application of the sealant if acute bleeding was observed (14 cases). We did not record any case of postoperative bleeding or renal failure. One patient required transfusion due to a big hematoma on the abdominal wall. 65% were clear cell carcinoma, 10% were papillary carcinoma, 20% were oncocitoma. Free margin rate was 100%. Mean hospital stay was 4 days (2–6). Mean follow-up was 14 months (5–45). ConclusionsExcluding renorrhaphy during laparoscopic partial nephrectomy is feasible and safe. Our initial experience with the vivostat system in laparoscopic partial nephrectomy has been encouraging, but longer follow-up is needed to determine the real benefit of this surgical technique in laparoscopic partial nephrectomy.

Off pump repair of left ventricular rupture following mitral valve replacement: The crucial assistance of the IntraAortic Balloon Pump

INTRODUCTIONLeft ventricular (LV) rupture is a not as frequent, but potentially lethal complication of mitral valve replacement or repair. PRESENTATION OF CASEWe report a case of a 67-year-old man who underwent mitral valve replacement and Cox Maze IV procedure. A massive bleed from the LV rupture was noted postoperatively while the patient was extubated. The control of bleeding was impossible until an IntraAortic Balloon Pump (IABP) was inserted. A bovine pericardial patch was applied, overlapping an extensive epicardial area, perimetrically of the hematoma. Between the epicardium and the pericardial patch we applied an autologous fibrin sealant. DISCUSSIONThe off-pump technique used to repair the LV rupture after a MVR, is more feasible when the patient is supported by an IABP that subsequently decreases the tension of the myocardial suture site. CONCLUSIONThe IABP, is a necessary device, that decreases the tension along the suture site post a left ventricular rupture following a MVR.

Control de la hemostasia durante la nefrectomía parcial laparoscópica sin renorrafia parenquimatosa: la experiencia Vivostat®

ObjectiveTo present our experience using an autologous fibrin sealant prepared with the Vivostat system® to control haemostasis without any renal parenchymal reconstruction. Material and methodsWe performed 45 laparoscopic partial nephrectomies using this haemostatic agent. The surgical steps were: colon mobilization, identification of ureter, renal vessels and renal tumor, renal artery control with Rummel tourniquet, tumor excision with harmonic scalpel, application of fibrin glue to the resection bed twice (before and after kidney reperfusion). Patients were evaluated for acute or delayed bleeding. ResultsMean age was 63.9 years (33-80); mean tumor size was 2.5cm (1.5-4); mean operative time was 136.1min (90-180). Mean warm ischemia time was 19.2min (10-30). Mean blood loss was 97ml (50-300). Individual haemostatic stitches were performed before application of the sealant if acute bleeding was observed (14 cases). We did not achieve any case of postoperative bleeding from resection bed or renal failure. 1 patient required transfusion due to an abdominal wall haematoma. 65% were clear cell carcinoma, 10% were papillary carcinoma, 20% were oncocitoma. Free margin rate was 100%. Mean hospital stay was 4 days (2-6). Mean follow-up was 14 months (5-45). ConclusionsExcluding renorrhaphy during laparoscopic partial nephrectomy is feasible and safe. Our initial experience with the vivostat system in laparoscopic partial nephrectomy has been encouraging, but longer follow-up is needed to determine the real benefit of this surgical technique in laparoscopic partial nephrectomy

Does the use of DuraSeal in head and spinal surgeries reduce the risk of cerebrospinal fluid leaks and complications when compared to conventional methods of dura mater closure?

INTRODUCTION Cerebrospinal fluid (CSF) fistula is a common neurosurgical complication, occurring in 1% to 27% of cases. The main clinical manifestations are postural headache, nausea, dizziness, photophobia, and tinnitus. This condition may be associated with inadequate wound healing and infection, meningitis, and pseudomeningocele, factors that increase patient morbidity and mortality. Despite the limitations, hermetic closure of the dura mater has been recommended for the prevention and treatment of CSF fistula. In recent years, techniques have been developed to reinforce the site of the dura mater closure, such as additional suture, autologous tissue grafts, fibrin sealants, and collagen sponges. DuraSeal is a dura mater sealant consisting of polyethylene glycol hydrogel (PEG hydrogel), to be applied at the site of suture, and has been indicated for head and spinal surgery with opening of the dura mater.

Biochemical, mechanical, and morphological properties of a completely autologous platelet-rich wound sealant

The optimal composition of fibrin sealant preparations is not known. We, therefore, sought to construct a series of sealants from autologous components and compare their functioning to Bioseal a commonly used sealant. Characteristics of the platelet-rich plasma, cryoprecipitate, and thrombin were determined and compared to commercial glue from composition, function, and microscopy aspects. The concentrations of platelets as well as fibronectin in autologous fibrin glues were significantly higher than those in commercial ones (P < 0.001). Mechanical values (maximum amplitude and clot strength) obtained from thrombelastograph assays in two groups were not significantly different (P > 0.05). A dense platelet surface and fibrin net structures could be observed in the autologous samples, whereas there were only sparse fibrin nets without cellular components in Bioseal. Characterization of autologous and Bioseal fibrin sealants and their performance do not have significant difference in biochemical and mechanical properties. The entirely autologous platelet-rich gel in the present study may get wide application in future practice after confirmation of its safety, efficiency, and economic benefits.

Use of autologous platelet rich fibrin in urethracutaneous fistula repair: preliminary report

Urethrocutaneous fistula (UCF) is one of the most common complications occurring after hypospadias repair. Despite the surgical advancement in hypospadias, multiple failed fistula closures are commonly referred to paediatric urologists. Although several techniques have been described to interpose a waterproof layer between urethral and skin closures, occurrence of urethrocutaneous fistula cannot be eliminated completely. In addition to several local tissue grafts, autologous and homologous fibrin sealants are used to prevent UCF. Platelet rich fibrin (PRF) is known as an autologous source of growth factors obtained from the sera of the patient. PRF supports collagen synthesis and tissue repair and accelerates wound healing. We aimed to present our initial experience about the use of autologous PRF in a 3-year-old boy with a UCF after hypospadias repair.

Several clinical interests regarding lung volume reduction surgery for severe emphysema: meta-analysis and systematic review of randomized controlled trials

ObjectivesWe aim to address several clinical interests regarding lung volume reduction surgery (LVRS) for severe emphysema using meta-analysis and systematic review of randomized controlled trials (RCTs).MethodsEight RCTs published from 1999 to 2010 were identified and synthesized to compare the efficacy and safety of LVRS vs conservative medical therapy. One RCT was obtained regarding comparison of median sternotomy (MS) and video-assisted thoracoscopic surgery (VATS). And three RCTs were available evaluating clinical efficacy of using bovine pericardium for buttressing, autologous fibrin sealant and BioGlue, respectively.ResultsOdds ratio (95%CI), expressed as the mortality of group A (the group underwent LVRS) versus group B (conservative medical therapies), was 5.16(2.84, 9.35) in 3 months, 3(0.94, 9.57) in 6 months, 1.05(0.82, 1.33) in 12 months, respectively. On the 3rd, 6th and 12th month, all lung function indices of group A were improved more significantly as compared with group B. PaO2 and PaCO2 on the 6th and 12th month showed the same trend. 6MWD of group A on the 6th month and 12th month were improved significantly than of group B, despite no difference on the 3rd month. Quality of life (QOL) of group A was better than of group B in 6 and 12 months. VATS is preferred to MS, due to the earlier recovery and lower cost. And autologous fibrin sealant and BioGlue seems to be the efficacious methods to reduce air leak following LVRS.ConclusionsLVRS offers the more benefits regarding survival, lung function, gas exchange, exercise capacity and QOL, despite the higher mortality in initial three postoperative months. LVRS, with the optimization of surgical approach and material for reinforcement of the staple lines, should be recommended to patients suffering from severe heterogeneous emphysema.

Topical use of autologous fibrin glue in high-risk CABG patients

BACKGROUND: Surgical site wound complications following cardiothoracic surgery are associated with increased costs, morbidity, and mortality. Several factors have been shown to be associated with an increase in deep and superficial wound healing problems. Recent publications have suggested protective effects of topical autologous blood components with regard to wound healing disturbances after various surgical procedures. The aim of this retrospective analysis was to assess the impact of autologous fibrin glue on surgical site complications in high-risk coronary artery bypass graft patients. METHODS: 1394 consecutive patients who underwent CABG surgery from a single centre were included in the study. Autologous fibrin glue was used in 122 patients (8.8%) with elevated risk for wound complications according to institutional guidelines. The demography of both groups was compared and the following outcome variables were analyzed: deep sternal wound infection, sternal re-wiring, bleeding, re- exploration rate, and the use of a vacuum assisted closure system. RESULTS: No treatment-related adverse events were noted. The group of patients who received autologous fibrin sealant had significantly higher BMI levels, included more diabetics and repeat cardiac procedures and they underwent percutaneous coronary intervention more often. Furthermore, they were more likely to receive bilateral mammary artery grafts. Despite the high-risk profile of the Fibrin glue group rates of revision, deep sternal wound healing problems tended to be lower than in the control group. CONCLUSIONS: In our experience autologous fibrin glue does not invoke any adverse events and serves as a useful adjunct to haemostasis in cardiac surgery. However, the incidence of wound disturbances was similar in both arms of the study. In light of the ever-increasing clinical use a prospective randomized controlled trial examining the impact of autologous fibrin glue is warranted.

Allogeneic single‐donor cryoseal produced from fresh‐frozen quarantine apheresis plasma as alternative for multidonor or autologous fibrin sealants

Fibrin sealant is a human blood product consisting of two components: cryoprecipitate and thrombin. Commercial fibrin sealants are produced from multidonors, increasing the viral risk, and contain fibrinolytic inhibitors such as tranexamic acid or bovine aprotinin. Autologous fibrin sealants reduce the viral risk and are mostly produced during a surgical procedure or well in advance. Alternatively, the allogeneic single-donor fibrin sealant cryoseal can be used. In this study cryoseal was characterized and the manufacturing consistency of the production process was investigated. Cryoseal was produced from plasma collected on apheresis machines using a commercial device. In a research setting the protein composition and recovery were determined. Also, the manufacturing consistency of the production process was tested in a research setting as well as in a routine setting. In the research setting all produced cryoseal met the quality control requirements of a clotting time of less than 10 seconds and the presence of Factor (F)XIII (qualitative). In the routine setting, one procedure per year did not meet these requirements. The protein composition showed the following mean ± standard deviation (%recovery) results: thrombin 25.7 ± 11.1 IU/mL, fibrinogen 19.9 ± 4.6 (15%) mg/mL, FVIII 15.6 ± 5.4 (44%) IU/mL, FXIII 2.7 ± 0.7 (6%) IU/mL, and plasminogen 1.8 ± 0.2 (4%) U/mL. In both research and routine settings the production process resulted in a consistent product. The cryoseal manufacturing process resulted in a consistent product, which meets the predetermined specifications. The single-donor origin and the absence of fibrinolytic inhibitors make cryoseal a good alternative for multidonor and autologous fibrin sealants.

A prospective, randomized trial comparing BioGlue and Vivostat for the control of alveolar air leak

BioGlue (CryoLife, Europa Ltd, Surrey, UK) is effective in reducing alveolar air leak after pulmonary resection. However, concerns exist regarding the use of bovine-derived products. Vivostat (Vivostat A/S, Alleroed, Denmark) is an autologous fibrin sealant that confers certain advantages. It shows superior elastic properties, a faster absorption time, and the absence of risk of transmission of blood-borne diseases. We conducted a randomized, single blind controlled study to compare BioGlue and Vivostat in the control of postoperative air leak. Primary endpoints were duration of air leak, time to intercostal drain removal, and length of hospital stay. Secondary endpoints related to postoperative complications. Between December 2005 and December 2007, 103 patients were randomized. The analysis included 102 patients; 67% were male. Median age was 56 +/- 19 years. Indications for surgery were primary lung cancer in 41 patients (40%), secondary malignancy in 48 patients (47%), carcinoid in 6 patients (6%), and 7 patients underwent surgery for benign disease (7%). Bilobectomy was performed in 2 patients (2%), lobectomy in 41 patients (40%), lobectomy with lesser resection in 3 patients (3%), segmentectomy in 16 patients (16%), precision excision in 34 patients (33%), and 6 patients underwent other resections (6%). Median duration of air leak was 3 (0-32) days versus 2 (0-33) days for patients who received BioGlue and Vivostat, respectively (P = .677). Time to intercostal drain removal was 5 (1-32) days in the BioGlue group compared with 5 (1-34) days for the Vivostat group (P = .473). Median hospital stay was 8 (3-22) days versus 7 (2-29) days for the BioGlue and Vivostat groups, respectively (P = .382). There was no significant difference in the incidence of complications between the 2 groups (20 patients receiving BioGlue versus 19 patients receiving Vivostat, P = .839). There were no significant differences in the 3 clinical outcome measures of duration of air leak, time to intercostal drain removal, and length of hospital stay in those patients receiving BioGlue or Vivostat. Given the inherent advantages of our institutional preference is to use Vivostat in the control of postoperative air leaks after pulmonary resection.