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Haemostatic / Tissue Adhesive (Biological — Human Plasma-Derived) Pregnancy: Section 4.6: 'The safety of fibrin sealants/haemostatics for use in human pregnancy or breastfeeding has not been established in controlled clinical trials. Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri-and postnatal development. Therefore, the product should be administered to pregnant and lactating women only if clearly needed.' Parvovirus B19 infection may be serious for pregnant women (section 4.4). The effects on fertility have not been established.

Fibrin Glue (Tissue Adhesive — Burns/Plastics)

Brand names: Tisseel, Artiss, Evicel, Quixil

A two-component biological tissue adhesive of fibrinogen and thrombin used in burns and plastics to secure skin grafts, seal raw surfaces and provide local haemostasis.

Adult dose

Dose: ARTISS as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and burn surgery (replacement or adjunct to sutures or staples), and as an adjunct to haemostasis on subcutaneous tissue surfaces: the amount and frequency of application are oriented to the clinical need and individualised by the treating physician (type of surgery, size of the area, mode of application, number of applications). In clinical trials individual dosages have typically ranged from 0.2-12 ml; for some procedures (e.g. sealing of large burned surfaces) larger volumes may be required. Guideline for gluing of surfaces: 1 pack of ARTISS 2 ml (1 ml Sealer Protein Solution plus 1 ml Thrombin Solution) is sufficient for an area of at least 10 cm2. By spray application: about 100 cm2 requires the 2 ml pack, 200 cm2 the 4 ml pack and 500 cm2 the 10 ml pack. Apply only a thin layer.
Route: Epilesional (topical) application, by dual-chamber syringe / spray - do not inject; subcutaneous tissue surfaces only
Frequency: Applied during the procedure; the application can be repeated to any small areas not previously treated, but not onto an already polymerised ARTISS layer
SCOPE: this SPC is for ARTISS (Baxter), one fibrin sealant brand; the page also lists Tisseel, Evicel and Quixil, whose SPCs are not covered and for which no dose is written here. Strength: Component 1 Sealer Protein Solution - human fibrinogen 91 mg/ml (as clottable protein) with synthetic aprotinin 3000 KIU/ml; Component 2 Thrombin Solution - human thrombin 4 IU/ml with calcium chloride dihydrate 40 micromol/ml; after mixing, pack sizes 2 ml, 4 ml and 10 ml (SPC section 2). For hospital use only, by experienced surgeons trained in its use. Skin graft fixation: attach the graft to the wound bed immediately after ARTISS is applied; the surgeon has up to 60 seconds to manipulate and position the graft before polymerisation; hold in position by gentle compression for at least 3 minutes. Dry the wound surface by standard techniques (do not use pressurised air or gas for drying). For spray application use a pressure regulator delivering a maximum pressure of up to 2.0 bar (29.0 psi), only on visible application sites, and respect the manufacturer's recommended pressure and spray distance (SPC section 6.6, not retrieved in the bundle). Not recommended for laparoscopic surgery; not for endoscopic spray use. No patients over 65 years were treated in clinical trials. Contains synthetic aprotinin - record any use of aprotinin products in the patient's records.

Dose adjustments

Renal

The SPC (section 4.2) states no renal dose adjustment.

Hepatic

The SPC (section 4.2) states no hepatic dose adjustment.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Not indicated to replace skin sutures intended to close surgical wounds (section 4.3)
  • Alone, not indicated for the treatment of massive and brisk arterial or venous bleeding (section 4.3)
  • Must never be applied intravascularly (section 4.3)
  • Hypersensitivity to the active substances or to any of the excipients (section 4.3)
  • Spray application should not be used in endoscopic procedures (section 4.3)
  • Not indicated where fast clotting of the sealant is required, in sealing of vascular anastomoses in cardiovascular procedures, in neurosurgery, or as suture support for gastrointestinal or vascular anastomoses (section 4.4)

Side effects

  • Common: pruritus; skin graft failure (section 4.8)
  • Uncommon: dermal cyst (section 4.8)
  • Air or gas embolism, which can be life threatening or fatal, related to spray devices used at higher than recommended pressure or in close proximity to tissue (sections 4.4, 4.8)
  • Intravascular injection could lead to thromboembolic events and disseminated intravascular coagulation (section 4.8)
  • Hypersensitivity or allergic reactions in rare cases, in isolated cases progressing to severe anaphylaxis; risk linked to aprotinin, especially on repeated exposure (sections 4.4, 4.8)
  • Antibodies against components of fibrin sealant may rarely occur (section 4.8)

Interactions

  • No formal interaction studies have been performed (section 4.5)
  • May be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions); remove such substances as far as possible before application (section 4.5)
  • Oxycellulose-containing preparations may reduce efficacy and should not be used as carrier materials (section 4.4)

Monitoring

  • When spraying: monitor changes in blood pressure, pulse, oxygen saturation and end-tidal CO2 because of the possibility of air or gas embolism (section 4.4)
  • Observe for signs of hypersensitivity (hives, generalised urticaria, chest tightness, wheezing, hypotension, anaphylaxis) and discontinue immediately if they occur (section 4.4)
  • Record the name and batch number of the product at every administration (section 4.4)

Clinical monograph

How it works

Mixing the components reproduces the final stage of the clotting cascade, with thrombin converting fibrinogen to a fibrin clot that adheres tissues and stops bleeding.

Prescribing in practice

  • It must never be injected intravascularly, as intravascular application can cause life-threatening thromboembolism.
  • Being derived from pooled human plasma, it carries a theoretical infection-transmission risk and may contain components contraindicated in known hypersensitivity, including to aprotinin where present.
  • Apply only to the tissue surface as a thin layer per the product instructions.

Monitoring

Monitor the application site for graft take, haemostasis and any hypersensitivity reaction.

Counselling the patient

  • This biological glue helps hold the graft in place and reduce bleeding.
  • It is absorbed by the body as the wound heals.
  • Report any rash, swelling or breathing difficulty after the procedure.

Evidence & guidelines

Fibrin sealants are well established for graft fixation and haemostasis in burns and reconstructive surgery, with labelling warning against intravascular use.

Reference: MHRA Drug Safety Update 2009 (air embolism); Tisseel/Artiss SPC; Currie et al. Burns 2013 (fibrin glue in STSG); NICE Interventional Procedures Guidance IPG537; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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