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Fibrin Sealants — Tisseel, Evicel, Artiss

Fibrin sealants are two-component biologic adhesives that reproduce the final common pathway of coagulation at the application site, delivering concentrated fibrinogen and thrombin simultaneously through a dual-syringe applicator. When the two components meet, thrombin immediately cleaves fibrinogen to form a fibrin clot that bonds tissue, seals bleeding surfaces, and reinforces suture lines. The clot is broken down during healing; absorption depends on formulation, amount and application site.[1][2]

Product indications differ: Tisseel is a surgical hemostatic adjunct and has a specific sealing indication for colonic anastomoses after temporary colostomy reversal. Artiss is an adhesive for burn skin grafts and facial-rhytidectomy flaps, and is not indicated for hemostasis.[3][4]

Product Examples​

ProductManufacturerClot formationDistinguishing feature
TisseelBaxterRapid; allow at least 2 minutes before disturbingThrombin 500 IU/mL (label range 400–625); synthetic aprotinin; frozen prefilled syringe or lyophilized kit; hemostasis adjunct plus colonic-anastomosis sealing[3]
Evicel (US presentations discontinued)[10]Ethicon (Omrix)RapidHuman fibrinogen with human thrombin 800–1,200 IU/mL; no aprotinin; hemostasis adjunct; spray with CO2-assisted or airless accessories per labeling[5][7]
ArtissBaxterUp to ~60 seconds (slow-cure)Low thrombin concentration (~4 IU/mL; label range 2.5–6.5); skin-graft adherence in burns and facial-rhytidectomy flap adhesion; not for hemostasis[4]
VistasealEthicon-distributed (manufactured by Grifols)RapidFibrinogen ~80 mg/mL; hemostasis adjunct for mild to moderate bleeding; supplied with a dual applicator[6]
RaplixaHistorical powder productN/ADry formulation

Specifications are from the manufacturers' US labeling.[3][4][5][6] Evicel has no aprotinin.[5]

Mechanism​

  1. Component A (fibrinogen ± aprotinin): pooled human fibrinogen, roughly 67–106 mg/mL in Tisseel and Artiss, with synthetic aprotinin (2,250–3,750 KIU/mL)[3][4]
  2. Component B: human thrombin with calcium chloride
  3. When mixed at the tissue surface:
    • Thrombin cleaves fibrinogen to fibrin monomer
    • Fibrin monomers polymerize into a stable clot, which strengthens over roughly the first two hours (Artiss label)
    • Calcium in the thrombin solution supports the reaction
    • Aprotinin (in Tisseel and Artiss) slows plasmin-mediated fibrinolysis, extending clot durability

Cure time by product​

  • Standard (Tisseel, Evicel, Vistaseal): high thrombin concentration; sets within seconds. Tisseel labeling asks for at least 2 minutes after application to reach adequate polymerization.
  • Slow-cure (Artiss): low thrombin; initial polymerization takes up to 60 seconds, which allows tissue repositioning / flap adhesion before setting.

GU Reconstruction Applications and Evidence Limits​

Fibrin glue has been described for dorsal buccal-graft fixation and application over the reconstructed urethra in six men undergoing bulbar urethroplasty, and as an interposing layer in laparoscopic vesicovaginal fistula repair in a 40-patient comparison.[11][12] They require a procedure-specific rationale and are not substitutes for watertight suturing, vascularized graft contact, tension control or appropriate drainage. For vesicovaginal fistula repair, a 2024 systematic review found insufficient evidence to determine whether fibrin glue improves fistula cure.[13]

TachoSil already carries fibrinogen and thrombin. Its tunical sealing technique is distinct from adding liquid fibrin sealant beneath a graft. See the patch companion and the operative Peyronie's pages for the described methods.

For skin-graft or flap adherence, Artiss provides up to 60 seconds of positioning time, followed by at least three minutes of gentle compression; the clot reaches final strength in about 2 hours. Artiss use for phalloplasty flaps is off-label; the product is not indicated for hemostasis.[4]

The 2025 publication of an IPP infection-prevention bundle reported 0/103 infections versus 4/115 historical controls at 12 months, with Evicel applied to corporotomy suture lines and the pump pocket. The bundle changed skin preparation (chlorhexidine-alcohol versus povidone-iodine), sealant use and drain practice simultaneously, and the controls were historical. Evicel was also applied to subcutaneous tissues; postoperative hematomas occurred in 1/103 bundle patients and 6/115 historical controls.[2]

Application and Safety​

Preparation time, thawing, warming, storage after preparation and applicator compatibility are product-specific. Follow the kit's preparation and storage instructions. Examples from labeling: frozen Tisseel and Artiss syringes must be fully thawed and warmed to 33–37 °C, never microwaved, and not refrigerated or re-frozen after thawing; Evicel components may be thawed in a refrigerator, at room temperature or at 37 °C; when thawed at 37 °C, the vials must not remain there longer than 10 minutes.[3][4][5] After thawing, use within 24 hours at room temperature or 30 days refrigerated. Do not refreeze Evicel or refrigerate it after room-temperature storage.[5]

  • Prepare the visible surface and apply a thin, even layer.[4] Excessive clot thickness can delay wound healing.[4]
  • Pressurized-spray gas embolism is potentially fatal. Use the product-approved applicator, gas, pressure and working distance. For open surgery, the Tisseel and Artiss labels specify EASYSPRAY at 10–15 cm and 1.5–2.0 bar (21.8–29.0 psi); EASYSPRAY must not be used in enclosed body cavities. Only Tisseel specifies DUPLOSPRAY MIS for minimally invasive surgery: CO2 only, 2–5 cm (3 cm recommended) and 1.18–1.50 bar. Artiss provides spray parameters only for open subcutaneous wounds. Evicel CO2-assisted spray uses 10–15 cm at 20–25 psi in open surgery. Laparoscopic tips use 4–10 cm at 15–20 psi (35-cm rigid) or 20–25 psi (45-cm flexible); labeled airless accessories require no external gas and a tip distance of at least 2 cm.[8] The supplied Vistaseal Dual Applicator has an airless tip held at least 2 cm from tissue; do not apply gas-regulator settings to it. Spray only on visible sites and only when the required distance can be assured. During pressurized spraying, monitor blood pressure, pulse, oxygen saturation and end-tidal CO2. Do not use air or gas to dry the field.[3][4][5][6]
  • Never inject a fibrin sealant into the circulation; intravascular application can cause thromboembolic events. Tisseel and Artiss also prohibit injection into highly vascularized tissue; Evicel is for topical application and must not be injected into tissue.[9] Tisseel, Evicel and Vistaseal are contraindicated for severe or brisk arterial bleeding; Tisseel additionally excludes severe or brisk venous bleeding; both Tisseel and Artiss are contraindicated in patients with known aprotinin hypersensitivity.[3][4][5][6]
  • Artiss contains aprotinin too. Anaphylaxis can occur with first or repeat exposure; document prior use and component allergies.[3][4]
  • All of these products contain human plasma-derived proteins. Evicel and Vistaseal are contraindicated in patients with prior anaphylaxis or a severe systemic reaction to human blood products. Confirm the individual patient's acceptance of plasma-derived components; donor screening and viral inactivation reduce but do not eliminate infectious-agent risk (including the vCJD agent and, theoretically, the classic CJD agent). Parvovirus B19 is hard to inactivate and matters most in pregnancy, immunocompromise and increased erythropoiesis.[3][4][5][6]
  • Alcohol, iodine and heavy-metal solutions can denature the proteins: rinse and dry the site if the field was prepared with them. Do not use oxidized cellulose-containing preparations as carrier materials for Tisseel or Artiss; their labels warn that these may reduce sealant efficacy.[3][4]
  • Costs and routine stock depend on the institution.

Fibrin Sealant vs. Collagen-Fibrinogen Patch vs. Hemostatic Matrix​

AgentRole
Fibrin sealant (this page)Liquid two-component products with distinct hemostatic, sealing or adhesive indications
TachoSil / collagen-fibrinogen patchSolid-phase fibrin sealant on an absorbable carrier — used for selected focal hemostatic applications; carrier and indication vary
FloSealThrombin + gelatin matrix for selected bleeding sites within its instructions
CyanoacrylatesSkin-closure products have specific external-skin restrictions; other formulations are distinct

See Also​

References​

1. Spotnitz WD. Fibrin sealant: the only approved hemostat, sealant, and adhesive — a laboratory and clinical perspective. ISRN Surg. 2014;2014:203943. doi:10.1155/2014/203943

2. Fathollahi A, Razdan S, Razdan S. Zero infection protocol in inflatable penile prosthesis surgery: a prospective cohort study using chlorhexidine-alcohol skin preparation and fibrin sealant hemostasis. Int J Impot Res. 2026;38:363–367. Published online 2025. doi:10.1038/s41443-025-01174-8

3. Baxter. Tisseel Fibrin Sealant: US prescribing information. Revised September 2025 (DailyMed record updated November 2025). Label.

4. Baxter. Artiss Fibrin Sealant: US prescribing information. Revised September 2025. Label.

5. Ethicon (Omrix Biopharmaceuticals). EVICEL Fibrin Sealant (Human): prescribing information. FDA-posted package insert.

6. Ethicon/Grifols. VISTASEAL Fibrin Sealant (Human): US prescribing information. Label.

7. Ethicon. "EVICEL Fibrin Sealant (Human): US prescribing information." Revised May 2018. DailyMed label.

8. Ethicon. "EVICEL Fibrin Sealant (Human): US prescribing information." Revised May 2018. DailyMed label.

9. Ethicon. "EVICEL Fibrin Sealant (Human): US prescribing information." Revised May 2018. DailyMed label.

10. U.S. Food and Drug Administration. "Crosseal, Evicel: BLA 125010 product details." Purple Book. Product details.

11. Barbagli G, De Stefani S, Sighinolfi MC, Annino F, Micali S, Bianchi G. "Bulbar urethroplasty with dorsal onlay buccal mucosal graft and fibrin glue." Eur Urol. 2006;50(3):467–474. doi:10.1016/j.eururo.2006.05.018

12. Choudhury S, Dutta A, Gupta N, Pal DK. "Interposing layer of fibrin glue: A new horizon in vesico-vaginal fistula repair." Urologia. 2022;89(3):484–487. doi:10.1177/03915603211004748

13. Thompson JC, Halder GE, Jeppson PC, et al. "Repair of vesicovaginal fistulae: A systematic review." Obstet Gynecol. 2024;143(2):229–241. doi:10.1097/AOG.0000000000005468