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Issue 54

Fibrin Sealant Matters Newsletter


BREAST SURGERY FIBRIN GLUE REDUCED DRAIN OUTPUT FOLLOWING LUMPECTOMY AND AXILLARY DISSECTION LAPAROSCOPY REDUCING LEAKAGE AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SINUS REPAIR 2 2 2 3 3 3 4 4 5 5 5 6 6 7 7 7 7 8 8 9 9 9 9

Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

CALVARIAL BONE AND FIBRIN SEALANT SUITABLE FOR FRONTAL SINUS OBLITERATION WOUND REPAIR FIBRIN SEALANTS AMONG THE EFFECTIVE DONOR SITE DRESSINGS. OPHTHALMIC SURGERY

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SUCCESSFUL IMPLANTATION OF A FIBRIN-GLUED INTRAOCULAR LENS. FIBRIN SEALANT FOR WOUND CLOSURE IN MLLER MUSCLE-CONJUNCTIVA RESECTION NERVE REPAIR PERIPHERAL NERVE REGENERATION USING FIBRIN GLUE/GROWTH FACTORS WOUND HEALING TRACE ELEMENTS IN A FIBRIN GLUE WITH KERATINOCYTES CAN IMPROVE HEALING MENISCAL REPAIR USE OF A FIBRIN GLUE CONTAINING CHONDROCYTES FOR MENISCAL REPAIR IN ANIMALS NEUROSURGERY FIBRIN GLUE DID NOT DECREASE PERSISTENT CSF LEAKS AFTER INCIDENTAL DUROTOMY. HAEMOSTASIS FIBRIN GLUE REDUCES POST-OPERATIVE BLEEDING IN CALVARIAL REMODELLING TISSUE ENGINEERING "AUTOLOGOUS" HEART VALVES BASED ON PATIENT-DERIVED FIBRIN-SCAFFOLD

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Breast surgery
Fibrin glue reduces the duration of lymphatic drainage after lumpectomy and level II or III axillary lymph node dissection for breast cancer: a prospective randomized trial.
Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant. Fibrin glue reduced drain output following lumpectomy and axillary dissection J Korean Med Sci. 2009 Feb;24(1):92-6. Epub 2009 Feb 28 Ko E, Han W, Cho J, Lee JW, Kang SY, Jung SY, Kim EK, Hwang KT, Noh DY. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. This randomized prospective study investigated the effect of fibrin glue use on drainage duration and overall drain output after lumpectomy and axillary dissection in breast cancer patients. A total of 100 patients undergoing breast lumpectomy and axillary dissection were randomized to a fibrin glue group (N=50; glue sprayed onto the axillary dissection site) or a control group (N=50). Outcome measures were drainage duration, overall drain output, and incidence of seroma. Overall, the fibrin glue and control groups were similar in terms of drainage duration, overall drain output, and incidence of seroma. However, subgroup analysis showed that fibrin glue use resulted in a shorter drainage duration (3.5 vs. 4.7 days; p=0.0006) and overall drain output (196 vs. 278 mL; p=0.0255) in patients undergoing level II or III axillary dissection. Fibrin glue use reduced drainage duration and overall drain output in breast cancer patients undergoing a lumpectomy and level II or III axillary dissection.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Please visit www.vivostat.com for more information

Laparoscopy
Evaluation of the outcomes of electrosurgical induced bowel injury treated with tissue glue/sealant versus sutured repair in a rabbit model.
Suture vs. biological glues for laparoscopic electrosurgical bowel injury J Endourol. 2009 Mar 10. Box GN, Lee HJ, Abraham JB, et al. Departments of Urology, University of California, Irvine, Orange, California. Introduction: Bowel injury is an uncommon, although potentially devastating, intraoperative laparoscopic complication. Questions have been raised about the possible use of a tissue adhesive to repair injured bowel. We compared glued repair and sutured repair of both large bowel (LB) and small bowel (SB) electrosurgical injuries in a rabbit model. Methods: Pneumoperitoneum was obtained, and four laparoscopic ports were placed in each of 48 New Zealand rabbits. The hook electrode was used in a specified manner to create an equal number of uniform full-thickness injuries to either the SB or the LB. Laparoscopic repair was performed with a 3-0 silk Lembert suture (LS), fibrin glue (FG), or BioGlue (BG), or repair was not performed (i.e., no repair, NR); the animals were monitored for 3 weeks. Adverse clinical outcomes and findings at laparotomy were recorded. Pathologic assessment included an objective scaled evaluation of the intensity of the inflammatory response and degree of healing.

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Results: In the SB injury group, deteriorating clinical condition necessitated early euthanasia in one animal repaired with FG, one animal repaired with BG, and two animals with NR. LS repair animals had no adverse clinical outcomes. The LB injury group had no adverse clinical outcomes regardless of the method of repair, including the control group. Of the animals that survived for 3 weeks, the animals repaired with BG had more intraabdominal adhesions (100%) than LS (33%), FG (55%), and NR (50%) (p = 0.001). The pathologic assessment revealed that BG induced a more intense inflammatory response (p < 0.05). Conclusion: In the rabbit, suture repair of an electrosurgical SB injury appears to have improved outcomes when compared with a glued repair. In contrast, LB injury responded well to any form of treatment. The data suggest that suture is superior to biological glues when dealing with a laparoscopic electrosurgical bowel injury.

Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

Decreasing anastomotic and staple line leaks after laparoscopic Roux-en-Y gastric bypass.

April 2009

Reducing leakage after laparoscopic Roux-en-Y gastric bypass It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF) Surg Endosc. 2009 Mar 5 Fullum TM, Aluka KJ, Turner PL. Department of Surgery, Howard University College of Medicine, Washington, DC, USA BACKGROUND: Anastomotic and staple line leaks (ASL) occur after laparoscopic Rouxen-Y gastric bypass (LRYGB) with a reported incidence as high as 6%. Leaks are the second most common cause of post-LRYGB mortality after pulmonary embolism, and can be associated with significant morbidity. Prevention and early detection may limit both morbidity and mortality. METHODS: A retrospective analysis of prospectively collected data was performed on all LRYGBs performed in a community hospital by a single surgeon from August 2001 to December 2005. All operations were performed using a linear-stapled anastomosis with buttressing material, handsewn otomy closures, stay sutures, intraoperative leak testing, and fibrin sealant. RESULTS: 760 patients underwent LRYGB during the study period. Eighty-nine percent (n = 674) were female and 11% (n = 86) were male. Mean body mass index (BMI) was 50 kg/m(2) (range 36-83 kg/m(2)). Mean age was 40 years (range 17-72 years). Two patients developed three gastric pouch staple line leaks (0.4%). There were no mortalities. CONCLUSION: Operative technique, including appropriate staple sizing, staple line reinforcement, handsewn otomy closures, placement of stay sutures, intraoperative leak testing, and placement of fibrin sealant contributed to a lower than expected incidence of ASL after LRYGB in this series.

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Sinus repair
Modified technique for frontal sinus obliteration using calvarial bone and Tisseel Glue.
Calvarial bone and fibrin sealant suitable for frontal sinus obliteration J Craniofac Surg. 2009 Mar 5 Kang GC, Sng KW, Tay AG. Department of Plastic, Reconstructive and Aesthetic Surgery, Singapore General Hospital, Singapore City, Singapore.

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BACKGROUND: Frontal sinus obliteration is indicated in trauma and frontal sinus disease. We present our experience with a modified technique of frontal sinus obliteration. METHODS: We reviewed the records of 17 patients who underwent frontal sinus obliteration with a combination of Tisseel fibrin glue (Baxter Healthcare Corporation, Deerfield, IL) and calvarial bone and describe our technique. RESULTS: One female and 16 male patients (mean age, 36.6) underwent frontal sinus obliteration from 2001 to 2005. Traumatic fracture was the most common indication. The patients were followed up for a median of 15 months. There were no major complications. Postoperatively, one patient developed a localized frontal wound infection at 3 weeks; this resolved with debridement. At latest follow-up, all were free from local sinus complications, disease recurrence, headaches, or intracranial events. CONCLUSIONS: The combined use of autogenous calvarial bone and Tisseel is suitable for frontal sinus obliteration. Our technique is associated with low donor site morbidity, avoids a separate donor surgical site, and has a low complication rate.

Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

April 2009

Wound repair
It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Multifunctional in situ photopolymerized semiinterpenetrating network system is an effective donor site dressing: a cross comparison study in a swine model.
Fibrin sealants among the effective donor site dressings. J Burn Care Res. 2009 Jan-Feb;30(1):37-45

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Kleinbeck KR, Faucher L, Kao WJ. Pharmaceutical Sciences Division, School of Pharmacy, University of Wisconsin-Madison, Wisconsin 53705, USA. Effective dressings for donor sites or other partial thickness wounds must promote removal of nonviable or necrotic tissue, eradication and prevention of microbial infiltrate, exudate absorbance, and regrowth of healthy epidermis and dermis. There are many commonly used products that facilitate these processes. Established properties of an in situ photopolymerizable semi-interpenetrating network (sIPN) suggest that it is also a viable treatment option. The widely varying material properties suggest that these dressing treatments may elicit different healing responses via different cellular mechanisms. In this study, we sought to resolve the differences in healing between Acticoat, sIPN, nonadherent dressing with Tisseel, and Xeroform dressing treatments in a porcine partial thickness wound model. Donor site wounds were produced on pigs at two cut depths and dressed with Acticoat, sIPN, nonadherent dressing with Tisseel, and Xeroform with alternatively placed autografts to provide a control area between each test site. Pigs were euthanized at 4, 7, 14, and 42 days for macroscopic examination and biopsy collection. Biopsies were analyzed histologically by two blinded observers for cellular densities and regional thicknesses within the tissue. sIPN- and Xeroform-treated wounds were healed by 7 days, and Acticoat- and nonadherent dressing with Tisseeltreated wounds were healed by 14 days. Inflammatory responses were between comparable treatment type across all time periods. Dermal granulation features increased with time but were not significantly different. All dressing treatments elicited wound healing without outstanding toxicity or pathology indicating that sIPN is a comparable and viable treatment for partial thickness wounds.

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Ophthalmic surgery
Anterior segment optical coherence tomography-aided diagnosis and primary posterior chamber intraocular lens implantation with fibrin glue in traumatic phacocele with scleral perforation.
Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant. Successful implantation of a fibrin-glued intraocular lens. J Cataract Refract Surg. 2009 Apr;35(4):782-4 Prakash G, Ashokumar D, Jacob S, Kumar KS, Agarwal A, Agarwal A. Dr. Agarwal's Eye Hospital and Eye Research Centre, Chennai, India. We describe the case of a middle-aged woman who presented to us after injury from a clenched fist 3 days previously.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

The diagnosis was occult scleral perforation, severe conjunctival chemosis, and traumatic aphakia. However, the lens could not be localized during posterior segment examination. An anterior segment optical coherence tomography (AS-OCT) examination showed scleral discontinuity and a heterogeneous reflection in the subconjunctival area, suggesting a possible phacocele. Surgical exploration confirmed these findings. Aphakia was managed using the "glued intraocular lens" technique in the same sitting. This case highlights the use of AS-OCT in noncontact exploration of the traumatized anterior segment and in diagnosis of a possible phacocele along with an occult scleral perforation with uveal prolapse. To our knowledge, this is the first report of successful implantation of a glued IOL as a primary procedure combined with scleral perforation repair.

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Comparison of fibrin sealant versus suture for wound closure in Mller muscle-conjunctiva resection ptosis repair.
Fibrin sealant for wound closure in Mller muscle-conjunctiva resection Ophthal Plast Reconstr Surg. 2009 Mar-Apr;25(2):99-102 Kavanagh MC, Ohr MP, Czyz CN, Cahill KV, Perry JD, Holck DE, Foster JA. Ophthalmic Surgeons and Consultants of Ohio, Columbus, Ohio, USA. PURPOSE: To compare fibrin sealant (Tisseel) versus suture for wound closure in Mller muscle-conjunctiva resection ptosis repair. METHODS: The charts of 114 patients (211 eyelids) who had undergone Mller muscleconjunctiva resection were retrospectively reviewed. Suture versus Tisseel were used for wound closure. Preoperative and postoperative eyelid measurements, postoperative symmetry within 0.5 mm, and complications were compared. RESULTS: Mller muscle-conjunctiva resection ptosis repair was performed on 211 eyelids of 114 patients. Seventeen cases were unilateral and 97 cases were bilateral. Method of wound closure included suture (45 eyelids of 31 patients) versus Tisseel (166 eyelids of 83 patients). For the suture group, the mean preoperative MRD1 was 1.2 mm and the postoperative MRD1 was 3.0 mm; the difference was 1.9. For the Tisseel group, the mean preoperative MRD1 was 1.2 mm and the postoperative MRD1 was 3.0 mm; the difference was 1.8. The 2 groups did not differ statistically in preoperative (p = 0.97) or postoperative MRD1 values (p = 0.53), the difference (p = 0.63), or postoperative symmetry within 0.5 mm (p = 0.39). In the suture group, complications in-

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cluded moderate to severe pain (10%), suture granuloma (6%), corneal abrasion (3%), loose suture (3%), and persistent keratopathy (3%). We found no evidence of keratopathy attributable to the Tisseel (p = 0.0001). This difference in the prevalence of complications was statistically significant (p = 0.0001). Four patients in the suture group (13%) underwent subsequent procedures including suture granuloma removal (2) and suture removal (1); 1 patient (3%) required levator resection. Three patients in the Tisseel group (4%) subsequently underwent levator resection. CONCLUSIONS: Mller muscle-conjunctiva resection ptosis repair using fibrin sealant for wound closure offers comparable eyelid position results compared with suture. Use of Tisseel showed fewer postoperative complications and was associated with fewer subsequent surgical procedures.

Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

Nerve repair
Improvement of peripheral nerve regeneration in acellular nerve grafts with local release of nerve growth factor.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Peripheral nerve regeneration using fibrin glue/growth factors Microsurgery. 2009 Mar 18 Yu H, Peng J, Guo Q, Zhang L, Li Z, Zhao B, Sui X, Wang Y, Xu W, Lu S. Key Laboratory of People's Liberation Army, Institute of Orthopedics, Chinese PLA General Hospital, Beijing, China. Previous studies have demonstrated the potential of growth factors in peripheral nerve regeneration. A method was developed for sustained delivery of nerve growth factor (NGF) for nerve repair with acellular nerve grafts to augment peripheral nerve regeneration. NGF-containing polymeric microspheres were fixed with fibrin glue around chemically extracted acellular nerve grafts for prolonged, site-specific delivery of NGF. A total of 52 Wister rats were randomly divided into four groups for treatment: autografting, NGF-treated acellular grafting, acellular grafting alone, and acellular grafting with fibrin glue. The model of a 10-mm sciatic nerve with a 10-mm gap was used to assess nerve regeneration. At the 2nd week after nerve repair, the length of axonal regeneration was longer with NGF-treated acellular grafting than acellular grafting alone and acellular grafting with fibrin glue, but shorter than autografting (P < 0.05). Sixteen weeks after nerve repair, nerve regeneration was assessed functionally and histomorphometrically. The percentage tension of the triceps surae muscles in the autograft group was 85.33 +/- 5.59%, significantly higher than that of NGF-treated group, acellular graft group and fibrin-glue group, at 69.79 +/- 5.31%, 64.46 +/- 8.48%, and 63.35 +/- 6.40%, respectively (P < 0.05). The ratio of conserved muscle-mass was greater in the NGF-treated group (53.73 +/- 4.56%) than in the acellular graft (46.37 +/- 5.68%) and fibrin glue groups (45.78 +/- 7.14%) but lower than in the autograft group (62.54 +/- 8.25%) (P < 0.05). Image analysis on histological observation revealed axonal diameter, axon number, and myelin thickness better with NGF-treated acellular grafting than with acellular grafting alone and acellular grafting with fibrin glue (P < 0.05). There were no significant differences between NGF-treated acellular grafting and autografting. This method of sustained site-specific delivery of NGF can enhance peripheral nerve regeneration across short nerve gaps repaired with acellular nerve grafts.

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Wound healing
Addition of zinc and manganese to a biological dressing.
Trace elements in a fibrin glue with keratinocytes can improve healing J Dermatolog Treat. 2009;20(2):90-3 Tenaud I, Saiagh I, Dreno B. UTCG, CHU Nantes, Institut de Biologie, Nantes Cedex, France. Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant. Background: Zinc and manganese, which are used in vivo because of their healing properties, have been shown to modulate in vitro integrin expression and to enhance keratinocyte migration. In addition, at the clinical level, a dressing of keratinocytes suspended in a fibrin glue has been proposed for the treatment of chronic wounds. Objective: To investigate whether the addition of trace elements to this dressing could modulate the migratory phenotype of keratinocytes via the modulation of integrin expression in a manner similar to an in vitro model and thus increase the healing properties of this dressing. Methods: Keratinocytes were mixed with Tissucol((R)) and maintained in culture for 12 days in a medium either supplemented or not with zinc or manganese. Then, integrin expression was studied by immunohistochemistry on fibrin clot cryosections. Results: We observed a significant increase of alpha5beta1 with zinc compared to the control medium. Zinc also enhanced alphaVbeta6 expression and manganese alpha5beta1, alphaVbeta5 and alphaVbeta6 expression, however without reaching a significant level Conclusion: By modulating integrin expression, trace elements can improve the efficiency of a biological dressing made of keratinocytes in a fibrin glue matrix and, thus, it appears beneficial to add them to this biological dressing for the treatment of skin defects.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Please visit www.vivostat.com for more information

Meniscal repair
Healing of meniscal tissue by cellular fibrin glue: an in vivo study.
Use of a fibrin glue containing chondrocytes for meniscal repair in animals Knee Surg Sports Traumatol Arthrosc. 2009 Mar 19 Scotti C, Pozzi A, Mangiavini L, Vitari F, Boschetti F, Domeneghini C, Fraschini G, Peretti GM. Department of Orthopaedics and Traumatology, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. Menisci represent fundamental structures for the maintenance of knee homeostasis, playing a key role in knee biomechanics. However, their intrinsic regenerative potential is poor. As a consequence, when a lesion occurs and the meniscus is partially removed by surgery, knee mechanics is subject to dramatic changes. These have been demonstrated to lead often to the development of early osteoarthritis. Therefore, menisci should be repaired whenever possible. In the last decades, tissue engineering approaches have been advocated to improve the reparative processes of joint tissues. In this study, the bonding capacity of an articular chondrocytes-fibrin glue hydrogel was tested as a biologic glue to improve the bonding between two swine meniscal slices in a nude mouse model. The composites were wrapped with acellular fibrin glue and implanted in subcutaneous pouches of nude mice for 4 weeks. Upon retrieval, a firm gross

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Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

bonding was observed in the experimental samples while none of the control samples, prepared with acellular fibrin glue at the interface, presented any sign of bonding. This was consistent with the histological and scanning electron microscope findings. In particular, a fibrocartilaginous tissue was found at the interface between the meniscal slices, partially penetrating the native meniscus tissue. In order to overcome the lack of regenerative properties of the meniscus, the rationale of using cellular fibrin glue is that fibrin provides immediate stability while carrying cells in the site of lesion. Moreover, fibrin gel is recognized as an optimal scaffold for cell embedding and for promoting fibrocartilaginous differentiation of the cells which synthesize matrix having healing property. These results demonstrated the potential of this model for improving the meniscal bonding. However, further orthotopic studies in a large animal model are needed to evaluate its potential for clinical application.

Neurosurgery
April 2009
Effect of fibrin glue on the prevention of persistent cerebral spinal fluid leakage after incidental durotomy during lumbar spinal surgery.
Fibrin glue did not decrease persistent CSF leaks after incidental durotomy. Eur Spine J. 2009 Mar 13 Jankowitz BT, Atteberry DS, Gerszten PC, Karausky P, Cheng BC, Faught R, Welch WC. Department of Neurological Surgery, Presbyterian Hospital and the Welch Neurosurgical Biomechanical Research Laboratory, University of Pittsburgh Medical Center, Suite B400, 200 Lothrop St., Pittsburgh, PA, 15213, USA.

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Please visit www.vivostat.com for more information

Approximately one million spinal surgeries are performed in the United States each year. The risk of an incidental durotomy (ID) and resultant persistent cerebrospinal fluid (CSF) leakage is a significant concern for surgeons, as this complication has been associated with increased length of hospitalization, worse neurological outcome, and the development of CSF fistulae. Augmentation of standard dural suture repair with the application of fibrin glue has been suggested to reduce the frequency of these complications. This study examined unintended durotomies during lumbar spine surgery in a large surgical patient cohort and the impact of fibrin glue usage as part of the ID repair on the incidence of persistent CSF leakage. A retrospective analysis of 4,835 surgical procedures of the lumbar spine from a single institution over a 10-year period was performed to determine the rate of ID. The 90-day clinical course of these patients was evaluated. Clinical examination, B-2 transferrin assay, and radiographic imaging were utilized to determine the number of persistent CSF leaks after repair with or without fibrin glue. Five hundred forty-seven patients (11.3%) experienced a durotomy during surgery. Of this cohort, fibrin glue was used in the dural repair in 278 patients (50.8%). Logistic models evaluating age, sex, redo surgery, and the use of fibrin glue revealed that prior lumbar spinal surgery was the only univariate predictor of persistent CSF leak, conferring a 2.8-fold increase in risk. A persistent CSF leak, defined as continued drainage of CSF from the operative incision within 90 days of the surgery that required an intervention greater than simple bed rest or over-sewing of the wound, was noted in a total of 64 patients (11.7%). This persistent CSF leak rate was significantly higher (P < 0.001) in patients with prior lumbar surgery (21%) versus those undergoing their first spine

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surgery (9%). There was no statistical difference in persistent CSF leak between those cases in which fibrin glue was used at the time of surgery and those in which fibrin glue was not used. There were no complications associated with the use of fibrin glue. A history of prior surgery significantly increases the incidence of durotomy during elective lumbar spine surgery. In patients who experienced a durotomy during lumbar spine surgery, the use of fibrin glue for dural repair did not significantly decrease the incidence of a persistent CSF leak. Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

Haemostasis
Calvarial remodelling for sagittal synostosis: does fibrin glue (Tisseel) reduce post-operative blood transfusion requirements?

April 2009

Fibrin glue reduces post-operative bleeding in calvarial remodelling It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF) Childs Nerv Syst. 2009 Mar 27 White N, Carver ED, Rodrigues D, Dover S, Magdum S, Nishikawa H, Solanki G. Department of Craniofacial Surgery, Birmingham Children's Hospital, Steelhouse Lane, Birmingham, B4 6NH, UK. INTRODUCTION: Calvarial remodelling for sagittal synostosis is extensive surgery and is associated with potential risks; the most significant of these is blood loss. MATERIALS AND METHODS: We studied 16 patients undergoing calvarial remodelling by the same surgical team over a 12-month period to determine whether scalp closure with fibrin glue (Tisseel) could decrease post-operative bleeding and the need for blood transfusion. In the last 5 months of the period studied, fibrin glue (Tisseel) was used and six out of the 16 patients had their wound closure assisted by this means. Data was prospectively collected on age at surgery, the estimated peri-operative blood loss, the volume of blood transfused intra-operatively, the volume drained in the first 8 h postoperatively, the total post-operative drainage and the volume of any post-operative blood transfusion required. RESULTS AND DISCUSSION: The two groups were comparable with a similar mean age at surgery, estimated peri-operative blood loss and intra-operative blood transfusion requirements. The volume drained in the first 8 h post-operatively was 172 ml in the treated group compared to 246 ml in the untreated group (p < 0.02) and the total post-operative drain volume was 301 ml compared to 441 ml (p < 0.01). None out of the six patients treated with fibrin glue required post-operative transfusion compared to two out of ten in the untreated group. The use of fibrin glue has enabled us to reduce post-operative bleeding and the need for post-operative blood transfusion.

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Tissue engineering
In vivo remodelling and structural characterisation of fibrin-based tissue-engineered heart valves in the adult sheep model.
"Autologous" heart valves based on patient-derived fibrin-scaffold Tissue Eng Part A. 2009 Mar 25

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Flanagan TC, Sachweh J, Frese J, Schnoering H, Gronloh N, Koch S, Tolba R, SchmitzRode T, Jockenhoevel S. University College Dublin, School of Medicine & Medical Science, Health Sciences Centre, Belfield, Dublin, Ireland Autologous fibrin-based tissue-engineered heart valves have demonstrated excellent potential as patient-derived valve replacements. The present pilot study aims to evaluate the structure and mechanical durability of fibrin-based heart valves following implantation in a large animal model (sheep). Tissue-engineered heart valves were moulded using a fibrin scaffold and autologous arterial-derived cells, before 28 days of mechanical conditioning. Conditioned valves were subsequently implanted in the pulmonary trunk of the same animals from which the cells were harvested. After 3 months in vivo, explanted valve conduits (n=4) had remained intact, exhibited native tissue consistency, although leaflets demonstrated insufficiency due to tissue contraction. Routine histology showed remarkable tissue development and cell distribution, along with functional blood vessel ingrowth. A confluent monolayer of endothelial cells was present on the valve surface, as evidence by scanning-EM and positive vWfstaining. Immunohistochemistry and extracellular matrix (ECM) assay demonstrated complete resorption of the fibrin scaffold and replacement with ECM proteins. Transmission-EM revealed mature collagen formation and viable, active resident tissue cells. The preliminary findings of implanted fibrin-based tissue-engineered heart valves are encouraging, with excellent tissue remodelling and structural durability after 3 months in vivo. The results from this pilot study highlight the potential for construction of completely "autologous" customised tissue-engineered heart valves based on a patientderived fibrin-scaffold.

Fibrin Sealant Matters is a monthly bulletin summarising recently published information on the properties and use of fibrin sealant.

April 2009

It is produced by Vivostat A/S, manufacturer of the Vivostat system - a medical device for the preparation and application of autologous fibrin sealant and Platelet Rich Fibrin (PRF)

Please visit www.vivostat.com for more information

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