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Comparison of the bonding power of various autologous fibrin tissue adhesives.

OBJECTIVE: Three known autologous fibrin tissue adhesives were evaluated for bonding power on Silastic and animal and human tissues. These adhesives were also injected into living tissue to determine if any of these fibrin glues cause inflammatory or deleterious reactions when kept in living tissue for a sustained period. METHODS: In Part I of our study, blood was drawn from 59 healthy volunteers, and autologous fibrin tissue adhesives were manufactured using the cryoprecipitation (AFTA-C), ammonium sulfate (AFTA-A), and ethanol/freezing (AFTA-E) methods. Blocks were then prepared using Silastic, porcine dermis, and human dura mater and bonded together for 10 or 30 minutes using the three adhesives. The blocks were then separated while bonding power was measured. In Part II of our study, 0.01 mL AFTA-C, AFTA-A, or AFTA-E was injected subcutaneously into the auricles of 60 rats. The rats were then killed 3, 7, 14, or 21 days later, and the auricles were examined histologically for signs of toxicity. RESULTS: The bonding powers of AFTA-E and AFTA-C were found to be statistically similar, and both were statistically stronger than AFTA-A. The injection of AFTA-A, AFTA-E, and AFTA-C into rat auricles did not cause any adverse effects. CONCLUSIONS: All three methods for manufacturing AFTA are effective in producing a reliable, stable fibrin glue. However, AFTA-E and AFTA-C demonstrate stronger bonding power than AFTA-A. In addition, all three forms of AFTA produce no undesirable tissue changes when injected into rat auricles.

Animals↗

Role of autologous fibrin tissue adhesive in abdominal surgery.

Fibrin tissue adhesive (FTA) is an agent developed for achieving better hemostasis and adhesion of living tissue. FTA appears to have no tissue toxicity, promotes a firm seal in seconds to minutes, is reabsorbed in days to weeks following application, and appears to promote local tissue growth and repair. It can be used in various surgical procedures. It has been used preoperatively, perioperatively and postoperatively in abdominal surgical procedures. There were no side effects. Improvement of surgical hemostasis was obvious in all patients. Anastomotic leakages were closed in a shorter time without surgical intervention. Sero-lymphatic drainage after surgical procedures that include extensive lymph node dissections was less. Use of FTA in treatment of fistula in ano was successful. The data would indicate that use of FTA may be a good alternative in solving various conditions in every day clinical practice, although a bigger randomized series, and longer follow up is needed.

Abdomen↗

Autologous fibrin tissue adhesive.

Various methods of making fibrin tissue adhesive from a patient's own blood were evaluated. The method using ammonium sulfate for fibrinogen preparation produced the greatest bonding strength. The average bonding strength of the commercially manufactured adhesive and of the autologous fibrin tissue adhesive were compared at 10 minutes and 30 minutes after glueing together 1 X 1 cm samples of fresh human dura. Results indicate the commercial glue holding 57 gms/cm2 at 10 minutes and 123 gms/cm2 at 30 minutes, while autologous glue prepared with the "ammonium sulfate method" has a bonding strength of 41 gms/cm2 at 10 minutes and 217 gms/cm2 at 30 minutes.

Ammonium Sulfate↗

Autologous fibrin tissue adhesive for ossicular reconstruction in cats.

Autologous fibrin tissue adhesive is currently the most promising adhesive for otologic use with respect to strength and biocompatibility without the risk of transmissable disease that is of concern with the commercially prepared fibrin adhesive. We set out to evaluate the practicality of preparing autologous fibrin adhesive in cats and to see if the adhesive's duration and strength of bonding was sufficient to allow natural tissue union to occur with various grafting materials. Autologous fibrin adhesive was prepared preoperatively from ten cats using the ammonium sulfate precipitation technique. Twenty otologic procedures were performed in which the incus long process was resected and the defect bridged with one of four grafting materials: autograft ossicular bone, bone pate-fibrin glue, porous hydroxylapatite, and Plastipore-bone pate. All grafts were secured with the autologous adhesive. The cats were sacrificed at 6 and 12 weeks. We found the the autologous adhesive provided adequate duration and strength of support to enable a firm tissue union between all the grafting materials and the adjoining incus and stapes.

Animals↗

The effect of autologous fibrin tissue adhesive on postoperative cerebrospinal fluid leak in spinal cord surgery: a randomized controlled trial.

STUDY DESIGN: A prospective randomized study evaluating the efficacy of autologous fibrin tissue adhesive for decreasing postoperative cerebrospinal fluid (CSF) leak in spinal cord surgery. OBJECTIVE: To compare postoperative CSF leak in 3 groups (i.e., autologous fibrin tissue adhesive used, commercial fibrin glue used, and no fibrin tissue adhesive used) of patients undergoing spinal surgery who needed dural incision. SUMMARY OF BACKGROUND DATA: Spinal cord operations, particularly when dural incision is inevitable, sometimes involve postoperative CSF leak. Because CSF leak is a serious complication, countermeasure is necessary to prevent it after dural suture. Commercial fibrin tissue adhesive was formerly used. Because the possibility of prion infection was widely noticed, commercial fibrin tissue adhesive containing animal components has been used less often. METHODS: In 13 of 39 cases in which dural incision would be made, 400 mL whole blood was drawn, and autologous fibrin tissue adhesive was made of plasma. Cases were divided into 3 groups: (1) dural closure alone, (2) use of autologous fibrin tissue adhesive after dural closure, and (3) use of commercial fibrin tissue adhesive after dural closure. The primary outcome measure was determined as postoperative (3 days) volume of drainage fluid, and results were analyzed using the analysis of variance. The secondary outcome measure was general blood test, coagulation assay, and plasma fibrinogen, and these were analyzed also using the analysis of variance. RESULTS: There was a significant difference in the primary outcome between the autologous and control groups. No complications such as infection or continuous CSF leak were observed in any case. The mean volume of drainage fluid was 586.2 mL in the group with autologous fibrin tissue adhesive and 1026.1 mL in the group without fibrin tissue adhesive. The volume of drainage fluid was significantly lower in the former group than that in the latter group. There was no statistical difference between the volumes of the group with autologous adhesive and with commercial adhesive (639.2 mL). CONCLUSIONS: We used autologous fibrin tissue adhesive as a new sealant after dural closure instead of commercial fibrin tissue adhesive. No definitive CSF leak was observed, and the volume of drainage fluid was significantly lower in the group with autologous fibrin tissue adhesive than that in the group without fibrin tissue adhesive. The use of autologous fibrin tissue adhesive was superior to that of commercial fibrin tissue adhesive in cost.

Adult↗

Repair of fistulas-in-ano using autologous fibrin tissue adhesive.

PURPOSE: Our goal was to determine if autologous fibrin tissue adhesive derived from the precipitation of fibrinogen using a combination of ethanol and freezing, could be used to completely close both simple and complex fistulas-in-ano. METHODS: A 26-patient pilot study was performed in which 100 ml of a patient's blood was drawn 90 minutes before surgery. Autologous fibrin tissue adhesive was prepared. In the operating room the patient underwent an examination under anesthesia, and the primary and secondary fistula tract openings were attempted to be identified. The fistula tract was curetted, and autologous fibrin tissue adhesive was injected into the secondary fistula tract opening until fibrin glue was seen coming from the primary opening. A petroleum jelly gauze was then applied over the secondary opening, and the patient was sent home. Follow-up visits were scheduled for one week, one month, three months, and one year later. RESULTS: Twenty-six patients received autologous fibrin tissue adhesive fistula injections, with a mean follow-up of 3.5 months. Initial results were encouraging. Twenty-one of 26 patients (81 percent) had successful initial closure of their fistulas. Two of five failures were injected a second time, and one closed, giving an overall successful closure rate of 85 percent (22/26 patients). Of five patients who failed, mean time to failure was 3.8 weeks. In addition, there was no evidence of infection or complications related to the procedure. CONCLUSION: Our initial results are optimistic and require further support through longer follow-up data. Fibrin glue treatment of anorectal fistulas offers a unique mode of management that is safe, simple, and easy for the surgeon to perform. By using autologous fibrin tissue adhesive the patient avoids the risk of anal incontinence and the discomfort of prolonged wound healing which may be associated with fistulotomy.

Adult↗

The current status of cyanoacrylate and fibrin tissue adhesives.

Surgical tissue adhesives could simplify complex surgical procedures by stabilizing tissue surfaces through hemostasis, sealing wounds, and fixating tissue in areas inaccessible to suture placement. The most common surgical tissue adhesives available to the surgeon include the cyanoacrylate derivatives and the fibrin tissue adhesives. Butyl-2 cyanoacrylate (Histoacryl) is a cyanoacrylate derivative that is frequently used in Canada and Europe. This adhesive has excellent binding strength for skin closure; however, subcutaneous implantation can result in inflammation and foreign body giant cell reaction. Fibrin tissue adhesives use a fibrin clot as the binding moiety and vary in adhesive strength depending on the fibrinogen concentration of the preparation. Autologous fibrin tissue adhesives are prepared using one of several different methods, which vary in fibrinogen yield and concentration. The currently available autologous fibrin tissue adhesives demonstrate good hemostatic properties with relatively low binding strengths. This article reviews the status of cyanoacrylate adhesives and the preparation, efficacy, and clinical applications of the fibrin tissue adhesives.

Animals↗

Autologous fibrin tissue adhesive: factors influencing bonding power.

Bonding power of Autologous Fibrin Tissue Adhesive (AFTA) is directly related to its fibrinogen concentration. By increasing the ammonium sulfate concentration 100% during fibrinogen precipitation, the bonding power of two glued 1-cm2 pieces of human dura almost doubled. No relationship between blood fibrinogen level and bonding power was demonstrated. Comparing AFTA with Fibrin Sealant, the commercial fibrin tissue adhesive, shearing strength between two glued pieces of human dura with AFTA was less 10 minutes and greater 30 minutes after gluing. Gluing a TORP (Richards) to a 1-cm2 piece of human dura yielded generally somewhat greater bonding power when using Fibrin Sealant. Autologous Fibrin Tissue Adhesive provides bonding power adequate for middle-ear surgery, eliminates transmission of viral diseases and, unlike Fibrin Sealant, AFTA is available in the United States.

Ammonium Sulfate↗

The efficacy of fibrin tissue adhesives in pleurodesis in rats.

In search for a new sclerosing agent for pleurodesis, fibrin tissue adhesive is compared to tetracycline for its efficacy in rats. Twenty-four albino Wistar rats were divided into 3 groups. Groups 1, 2, and 3 were given intrapleural isotonic saline, 35 mg/kg tetracycline, and fibrin tissue adhesive with fibrinogen and thrombin concentrations of 30 mg/mL and 10 U/mL, respectively. Rats were evaluated for macroscopic pleural adhesions and mean values of macroscopic scoring were compared among the groups. Fibrin tissue adhesive- and tetracycline-treated rats had significantly more adhesions compared to the control group, whereas fibrin tissue adhesive was more effective for pleurodesis than tetracycline and no deaths or major side effects were observed in any rat. Thus, fibrin tissue adhesive was found as a more effective sclerosing agent than tetracycline for pleurodesis in rats.

Animals↗

Human fibrin tissue adhesive for sutureless lamellar keratoplasty and scleral patch adhesion: a pilot study.

PURPOSE: To determine whether a fibrin adhesive can facilitate the performance of sutureless lamellar keratoplasty and attachment of amnion to bare sclera. DESIGN: Prospective, noncomparative case series. PARTICIPANTS: Six patients, 5 of whom underwent lamellar keratoplasty and 1 who received an amniotic patch of the sclera and cornea. Institutional review board approval was not required for these therapeutic treatments. METHODS: In 5 patients, the epithelium was removed from the corneal surface, a free cap, 200- micro m thick, was cut with a microkeratome, and a human fibrin tissue adhesive (Tisseel VH Fibrin Sealant; Baxter Healthcare Corporation, Glendale, CA) was applied to the cut surface of the corneal stroma. A 200- micro m thick, microkeratome-cut lamellar graft was placed in the stromal bed without sutures, and a bandage soft contact lens was applied. The lens was left in place for 1 week and then removed. In 1 patient, the adhesive was applied to bare sclera for attachment of amniotic membrane after removal of a conjunctival melanosis. All patients were followed up for 3 months after surgery. MAIN OUTCOME MEASURES: Tissue adhesion, corneal clarity, and visual acuity. RESULTS: All 5 lamellar grafts healed and remained clear, although final visual acuity varied with visual potential and astigmatism. The amniotic membrane graft also adhered well to the bare sclera. CONCLUSIONS: The fibrin adhesive provided satisfactory attachment without sutures for lamellar keratoplasty and amniotic patching. It should be effective for sealing of clear cornea incisions, LASIK flaps, and conjunctival and skin grafts. An adhesive that has been designed specifically for ophthalmic applications and is more convenient to use would be desirable.

Adolescent↗

The role of fibrin tissue adhesives in flap necrosis in rats.

Flap necrosis is an important issue in surgery, and fibrin tissue adhesives, due to beneficial properties in preventing flap necrosis, were used in this study. Two groups, each comprising of 10 rats, were formed. Group I served as a control group, and fibrin tissue adhesive was applied to group II. The fibrinogen and thrombin concentrations in fibrin tissue adhesive were 30 mg/ml and 10 U/ml, respectively. The mean area of flap necrosis was 687.5 +/- 72.5 mm2 and 78.5 +/- 11.0 mm2 in the control and fibrin tissue adhesive groups (p < .0001), respectively. The percentage of flap necrosis was significantly lower in the fibrin tissue adhesive group compared to the control group (5.6% vs 49.1%) (p < .0001). Fibrin tissue adhesives decreased flap necrosis significantly compared to the control group.

Animals↗

Autologous fibrin tissue adhesive in endoscopic sinus surgery.

Endoscopic sinus surgery may be complicated by bleeding, formation of synechia, and infection. This study investigated the application of autologous fibrin tissue adhesive during endoscopic sinus surgery in an attempt to avoid packing, to decrease complications, and to improve healing. Fibrin tissue adhesive from pooled human blood is a hemostatic and bacteriostatic agent. Autologous fibrin tissue adhesive avoids the potential infectious and immunologic risks of the pooled blood product. Twelve patients undergoing bilateral endoscopic sinus surgery participated in the study. Phlebotomy and preparation of the adhesive were performed during the procedure. Fibrin tissue adhesive was applied to only one side, with the contralateral side used as a control. Bacitracin ointment was applied to the adhesive-treated side, and packing coated with bacitracin was placed on the contralateral side. Patients were observed for a minimum of 3 months, and results were documented with photographic and video recordings. A uniformly high degree of patient satisfaction was achieved because of the elimination of packing and a sensation of increased nasal airway patency on the fibrin-treated side. Fibrin tissue adhesive provided hemostasis, decreased crusting, accelerated mucosal healing, and diminished synechia. Autologous fibrin tissue adhesive is beneficial in endoscopic sinus surgery, and its application should be considered, especially when the risk of hemorrhage or synechia is increased.

Adult↗

Safety and efficacy of currently available fibrin tissue adhesives.

PURPOSE: The purpose of this study is to review preparation methods, bonding power, preparation time, and costs associated with currently available autologous and homologous fibrin tissue adhesive preparations. METHODS: Two autologous fibrin tissue adhesive preparations (AFTA-A and AFTA-E), a single-donor homologous preparation, and 2 multiple-donor pooled homologous fibrin tissue adhesives, Vi-Guard and Tisseel, were evaluated and compared in relation to bonding power, preparation time, cost, bicompatibility, and biodegradability. RESULTS: Vi-Guard and Tisseel showed significantly greater bonding strengths than their single-donor counterparts. AFTA-C offers the quickest preparation time. All preparations were found to be similar in biocompatibility and biodegradability in soft tissue tests. Histology showed no infection or tissue reaction from adhesive exposure in any of the preparations. CONCLUSION: The optimal choice of a fibrin tissue adhesive is determined by the particular clinical indication. Currently available fibrin tissue adhesives vary appreciably in their bonding strength, cost, level of exposure risk, and preparation methods and times. Autologous preparations, which offer optimal safety, lack the strength and availability characteristics found with the multiple-donor preparations.

Absorbable Implants↗

Technical manual for manufacturing autologous fibrin tissue adhesive.

PURPOSE: The aim of this article is to provide a concise and simple technical manual for manufacturing autologous fibrin tissue adhesive derived from the precipitation of fibrinogen using a combination of ethanol and freezing for surgery. METHODS: All materials and equipment needed to manufacture ethanol-based autologous fibrin tissue adhesive are listed. In addition, step-by-step instructions are provided to allow for easy and rapid fibrin adhesive production. RESULTS: Ethanol-based autologous fibrin tissue adhesive can be manufactured in under 60 minutes. Furthermore, at our institution the startup cost for manufacturing ethanol-based autologous fibrin tissue adhesive was under $2,500.00. CONCLUSION: Ethanol-based autologous fibrin tissue adhesive is a safe, reliable, and easily manufactured autologous fibrin tissue adhesive that can be made by a trained technician in any blood bank, pharmacy, or surgical laboratory.

Ethanol↗

Comparison between fibrin tissue adhesive, epineural suture and natural union in intratemporal facial nerve of cats.

Our objective was to study intratemporal anastomosis of the facial nerve in cats. Clinical, electrophysiological and histological results of the use of fibrin tissue adhesive, epineural suture and natural adhesion were compared. The 30 adult cats studied had undergone mastoidectomy exposure, and section of the facial nerve 1 cm before its exit from the stylomastoid foramen. Anastomosis was then undertaken, using epineural suture combined with stabilization through fibrinic tissue adhesive, and union of the stumps without stabilizing them. Each type of anastomosis was carried out in 10 animals. Clinical, electrophysiological and histological assessments of both the site of anastomosis and the ventral branch of the facial nerve followed the aforementioned procedures. By means of statistical analysis, the authors reached the following conclusions: 1) Considering the clinical assessment per se, both groups with fibrinic tissue adhesive and suture showed similar features and results, which in both cases were better than those following natural union. 2) Considering the electrophysiological results per se, the use of fibrin tissue adhesive was superior to any other method used. 3) Considering the histological examination per se, both groups with fibrin tissue adhesive and suture revealed similar features which were more favourable than those shown by natural union. 4) In the overall comparison of the various parameters in the three groups, the use of fibrin tissue adhesive achieved better results than any other method. Based on the results of this study, the authors conclude that the use of fibrin tissue adhesive has technical advantages, and that the results of this use outweigh those achieved with both epineural suture and natural union. The authors recommend this technique as the most beneficial to be resorted to, for intrapetrous anastomosis of the facial nerve.

Anastomosis, Surgical↗

[Sutureless lamellar keratoplasty by microkeratome combined with fibrin tissue adhesive in rabbits].

OBJECTIVE: To evaluate the feasibility and safety of sutureless lamellar keratoplasty by microkeratome combined with fibrin tissue adhesive. METHODS: Twenty-four New Zealand white rabbits were divided into two groups, the donor grafts and recipient beds were made by the microkeratome, the grafts were glued over the stoma bed using the commercial product Tisseel in one group; and grafts without tissue adhesive were used as the control group. Corneal refractive power was measured by automated keratometer preoperatively and in 3 days, 2 weeks, 1 and 3 months postoperatively. Rejection and cornea transparency were observed. Confocal microscopy was used to observe corneal wound healing response and to measure the keratocyte and endothelium densities in vivo. Corneal wound healing was also evaluated using light and fluorescence microscopy. RESULTS: Ninety-two percent (11/12 eyes) of the glued grafts were retained in the Tisseel group, whereas all grafts were lost in the control group. All survived grafts were clear 1 month after surgery. However, in the control group, severe haze in the grafts occurred 2 weeks postoperatively. Confocal microscopy showed that there was a significant decrease of the keratocyte density surrounding the lenticule-host interface, and no changes occurred in the posterior keratocyte and endothelium. Histopathologic observations demonstrated the presence of a line of amorphous eosinophilic substance in the lenticule-host interface at 3 days after surgery, but the line disappeared after 1 month. Fluorescence microscopy showed no detectable regenerated stromal tissue. CONCLUSIONS: This initial study demonstrates sutureless optical lamellar keratoplasty performed by microkeratome combined with fibrin tissue adhesive is a simple and safe technique. Stromal wound healing response to this surgery is minimal. Fibrin tissue adhesive has no influence on the cornea optical property.

Animals↗

An evaluation of fibrin tissue adhesive concentration and application thickness on skin graft survival.

OBJECTIVES: To examine the effects of fibrinogen concentration and application thickness of fibrin tissue adhesive on skin graft survival. STUDY DESIGN: Prospective controlled study. METHODS: Ten domestic pigs were included in the study. A 20 x 5-cm area of skin was harvested bilaterally along the flanks of the animals using a Padgett dermatome. The harvested grafts were trimmed into four 4 x 4-cm squares. Donor sites were treated according to group assignment and the non-meshed grafts were placed on the side opposite their initial orientation and secured with staples. Both single- and multiple-donor human fibrin tissue adhesive preparations, with low and high average fibrinogen concentrations of 30 mg/mL and 60 mg/ mL, were used. Adhesive preparations were applied in either a thin layer (0.015 mL/cm2) or a thick layer (0.06 mL/cm2) using a spray applicator. A constant thrombin concentration of 10 U/mL was used in the study. No adhesive was used in the control group and grafts were stabilized with staples. No topical dressings were applied to any of the treatment sites. Animals were sacrificed 4 weeks after graft application. RESULTS: Based on statistical analysis, thickness of adhesive application had a significant effect on skin graft survival. Percent mean graft survival in the control and thin application groups was found to be 92% and 97.8% respectively; the mean survival rate in the thick application group was 63.1%. Fibrinogen concentration, when evaluated independently within the thin and thick application groups, was found to have no significant effect on graft survival. CONCLUSION: Independent of fibrinogen concentration, a thin layer of fibrin tissue adhesive, when applied between two opposing surfaces, does not interfere with and may support the healing process, whereas a thick layer of adhesive inhibits skin graft healing.

Animals↗

Extended experimental and preliminary surgical findings with autologous fibrin tissue adhesive made from patients own blood.

A surgical tissue adhesive can be made from the patient's own blood. We have been refining the procedures for manufacturing autologous fibrin tissue adhesive to facilitate its use in the operating room and to increase its bonding strength. Fibrin tissue adhesive efficacy depends on fibrinogen concentration. We found that fibrinogen precipitation using the ammonium sulfate method produced the highest concentration. Bonding power was compared with that of the commercial glue 10 minutes and 30 minutes after glueing two pieces of 1 X 1 cm2 human dura together. Bonding strength of the autologous product was close to that of the commercial product. Comparisons of fibrinolysis inhibition time of autologous fibrin tissue adhesive and commercial glue in experiments on rats over a period of one hour to six days after subcutaneous injection are described.

Aminocaproates↗