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Evicel

Manufactured by Johnson & Johnson
Sourced in United States, France

Evicel is a surgical sealant product developed by Johnson & Johnson. It is a two-component fibrin sealant that helps control bleeding during surgical procedures.

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14 protocols using evicel

1

Fibrin Scaffold Formation for Preantral Follicles

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The protocol used for the formation of a fibrin scaffold was a modification of the one previously described by Paulini et al. [53 (link)]. Evicel® is a fibrin sealant kit, routinely used in surgery and approved for clinical applications (Evicel®, Ethicon, France), which contains a solution of human fibrinogen (70 mg/ml) and a solution of human thrombin (1000 IU/ml). The stock solution of fibrinogen was diluted in alpha-minimum essential medium (αMEM, Sigma Aldrich, France) to obtain a final concentration of 50 mg/ml. Meanwhile, a stock solution of thrombin was also diluted in αMEM to obtain a final concentration of 10 IU/ml. A droplet of 15 μl of fibrinogen was placed in a 4-well cell plastic culture plate in which 30 to 100 preantral follicles isolated with GMP grade collagenase NB6 were carefully placed. No prior filtration step was carried out on ovarian suspensions from which isolated follicles would be embedded in fibrin matrices. The droplet containing isolated follicles was then mixed with 15 μl of thrombin solution. The resulting droplet of 30 μl was finally incubated 45 min at 37 °C to allow the fibrin to polymerize.
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2

Hydrogel Adhesive Strength Evaluation

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Hydrogels were synthesized using varying concentrations of BG-5/5 (1, 5, 10, and 20% (w/v)) as described above. The shear strength of the composites was evaluated according to a modified ASTM F2255–05 standard test (Nasim Annabi et al., 2017 (link)). Briefly, composites were formed in situ by pipetting 10 μl of the precursors between two pieces of gelatin-coated glass slides followed by photocrosslinking via visible light. The hydrogels were then placed between the clamps of the Instron mechanical tester and pulled apart at a strain rate of 10 mm min−1. Shear strength was calculated at the point of detaching. The commercially available sealant Evicel® (Ethicon) was used as a control.
Wound closure was calculated using a modification of the ASTM F2458–05 standard test (Nasim Annabi et al., 2017 (link)). For this, porcine bone and skin samples (strips; length: 30.00 mm, width: 10.00 mm, depth: 2 mm) were prepared and glued to glass slides. Hydrogels were placed between the clamps of the Instron machine at a distance of 6 mm. The composites were then photocrosslinked between the tissue samples and the adhesive strength was recorded at the point of tearing at strain rate of 1 mm min−1. The commercially available sealant Evicel® (Ethicon) was used as a control.
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3

Cartilage Defect Repair in Animal Model

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After a 12-hour preoperative fast, animals were sedated using tiletamine and zolazepam (Telazol; Zoetis, Kalamazoo, MI; 2-8 mg i.m./kg), intubated endotracheally, and anesthetized with isoflurane. After surgical disinfection of the knee, a medial patellar skin incision was made, and the knee joint was exposed via a lateral dislocation of the patella. Twenty-six 5 x 5 x 5 mm full-thickness cartilage defects were created in 10 knee (stifle) joints using a bone curette (FST, Foster City, CA; Figure). Two defects were created in the medial femoral intercondylar groove of all 10 knee joints and two additional defects were created in the lateral femoral intercondylar groove of 3 knee joints (total n = 26). The subchondral endplate was carefully preserved. The cartilage defects were implanted with MegaPro-labeled MSCs (n = 9), MegaPro-labeled chondrogenic pellets (n = 6), ferumoxytol-labeled MSCs (n = 3), and ferumoxytol-labeled chondrogenic pellets (n = 4) or were left unlabeled (n = 4). Cell implants were secured with fibrin glue (Evicel®, Ethicon, Somerville, NJ), the patella was repositioned and the stifle joint capsule, muscle layers, and skin were closed with absorbable sutures.
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4

Shear Strength of Tissue Adhesives

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The shear strength test was performed according to reference ASTM F2255-05, a standard test method used to determine the lap-shear strength properties of tissue adhesives under tension loading by a material testing system machine (MTS, H1KT, Tinius Olsen, Horsham, PA, USA). Briefly, fresh defatted porcine skin was cut into 2.5 × 2.5 cm2 strips and fixed on a glass substrate with cyanoacrylate glue. We applied 100 μL of the mixed solution to the porcine skin strips, which resulted in an overlap area of 1 cm2. Subsequently, the overlap area was irradiated by an LED curing light at a fixed distance of 1 cm for a defined number of seconds. The two skin substrates were bonded together for an additional 10 minutes with a clamp before the two glass substrates were fixed on the specimen holder of the MTS (Figure 1a). A commercially available fibrin adhesive (EVICEL®, Ethicon, Inc., Somerville, NJ, USA) was used as a control. To measure the compression resistance, the gel sample was placed on the stage of the MTS (Figure 1b). The working load of the MTS machine was 50 N, and the rate was 100 mm/min.
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5

Bioadhesive Sealant Burst Pressure

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Sealing capability of engineered bioadhesives and commercially available sealants, CoSEAL (Baxter, Deerfield, IL, USA) and Evicel (Ethicon, Somerville, NJ, USA), were measured according to a modified ASTM standard, F2392-04, for burst pressure, as described previously (47 ). Briefly, porcine intestine was fixed in the middle of two stainless steel annuli, using a custom-made burst pressure apparatus in which the upper annuli contained a 10-mm-diameter hole. Using an 18-gauge syringe needle, a 2-mm-diameter hole was created in the intestine tissue. Next, 30 μl of prepolymer solution was pipetted on the defect area and quickly cross-linked by visible light. Next, the air was applied into the system, and the maximum burst pressure was recorded by using a wireless sensor (Pasco) (n ≥ 3).
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6

Comparative Evaluation of Surgical Sealants

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The various surgical sealants used in ex vivo testing include SepraFilm (Baxter, Deerfield, IL, USA), DuraSeal (Integra LifeSciences, Plainsboro, NJ, USA), Evicel (Ethicon, Somerville, NJ, USA), Surgicel (Ethicon), and Coseal (Baxter).
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7

Fabrication of Fibrin Hydrogel Implants

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Fibrin hydrogels were formed using the Evicel (Ethicon; Somerville, NJ) fibrin glue kit as previously described [24 (link)] at a final mixing concentration of 40 mg/mL Fibrinogen and 33 U/mL thrombin. The mixture was placed in a custom mold to achieve a thickness of 200μm and incubated for 2 hrs at 37°C to achieve gelation. The gel was then hydrated in PBS for a minimum of 1 hr at 37°C. Individual implants were obtained by using a custom punch of 1.5mm wide x 5.0mm long, to achieve the desired geometry of an oblong shaped implant with rounded edges (Fig 1A). Implants were stained in 0.04% trypan blue solution (Gibco; Waltham, MA) to facilitate visualization during the surgical and post-operative examination. Following production, implants were stored in phosphate buffered saline (PBS) at room temperature.
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8

Burst Pressure Measurement of Surgical Sealants

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The burst pressure of GelMA/NP and commercially available surgical sealants Evicel® (Ethicon, Somerville, NJ, USA) and Coseal™ (Baxter, Deerfield, IL, USA) were measured based on the standard ASTM F2392–04 testing methodology. Porcine intestine (Savenor’s Market) was cut to a dimension of 40 mm× 40 mm. Next, the porcine intestine was placed between two stainless steel plates (35 mm× 35 mm), in which the upper piece had a 10-mm-diameter hole in its center and a circular defect (2 mm in diameter) was created on the center of the porcine intestine (Figure S10A). 20 μl of the adhesive was injected on the defect and, in the case of GelMA, the precursor was exposed to visible light. Next, the porcine intestine was placed into the burst pressure testing system, consisting of a pressure sensor, a recording unit. Air was then applied using a syringe pump at a rate of 5 ml/s to the sample until bursting (n ≥ 5).
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9

Fibrin Gel Fabrication for iPSC-RPE Culture

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Fibrin gels were made as previously described using a clinical grade kit (Evicel; Ethicon, Somerville, NJ) 8. Briefly, a mixture of 30 mg/ml fibrinogen and 50 U/ml thrombin (final concentrations) was mixed in a well of a 12‐well plate (total 100 μl), and a custom polycarbonate mold with parafilm lining was used to flatten the gel within the well and minimize the minicus effect. The 30 mg/ml fibrinogen concentration was chosen because it is comparable to fibrin glue concentrations and our previous work demonstrating iPSC‐RPE culture 8. The 50 U/ml thrombin concentration was chosen to provide some time for mixing and applying the mold prior to gelation. This resulted in a 4 cm2 area gel, with a thickness ranging from 200 to 300 μm. The gel was allowed to fully polymerize for 2 hours at 37°C prior to washing with phosphate‐buffered saline (PBS) and seeding the iPSCs. Culture media was supplemented with 50 U/ml aprotinin to investigate preservation of the gel.
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10

Adhesive Strength of Bioadhesives and Commercial Adhesives

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The lap shear strength of the bioadhesives and two commercial adhesives Evicel® (Ethicon, Somerville, NJ, USA) and CoSEAL™ (Baxter, Deerfield, IL, USA) was determined according to a modified ASTM test (F2255–05). Both titanium and glass slides were used as the substrates. Glass slides (10 mm × 30 mm) were coated with gelatin solution and dried at 37 °C. For adhesive tests on titanium, a piece of titanium (10 mm × 10 mm) was attached to a glass slide and 10 μl of the precursor solution was photocrosslinked between the titanium and the gelatin coated glass slide. The lap shear strength of the adhesives was then measured under tensile stress at a rate of 1 mm/min using an Instron mechanical tester. The ultimate stress was reported as shear strength of the bioadhesives (n ≥ 5). Similarly, 10 μL of the commercial adhesive material was tested as control.
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