Fibrin Glue for Pterygium Surgery

Sathish Srinivasan FRCSEd, FRCOphthConsultant OphthalmologistAyr Hospital, AyrScotland, UK

No financial interest

• Introduction

• Chemical composition

• How to mix

• How to apply

• Results

• A two-component fibrin sealant.

• Contains two of the protein that makes the blood clot.

• Fibrinogen and thrombin

• SEALANT PROTEIN: solution composed of Human fibrinogen, plasminogen, fibronectin and Factor XIII reconstituted in a Bovine aprotinin solution

• SEALANT SETTING: solution composed of Human thrombin reconstituted in a calcium chloride solution

Simulates Physiological Clotting

Plasma clot Tisseel A non-physiologic sealant

What can you do with Tisseel?

• Control intra-operative bleeding

• Prevent post-operative haemorrhage

• Repair leaks including CSF

• Prevent post-op leakage including CSF

• To promote tissue adhesion

• To support a suture line

Fibrin Glue

• Complement good surgical haemostatic techniques, such as• Ligatures or sutures• Clips or staples• Electrocautery

• Provide a water or fluid-tight seal

CAN….

•Stop arterial bleeding

•Stop severe venous bleeding

CANNOT….

Clinical experience with Tisseel

• No documented transmission of:– HIV, Hepatitis B, Hepatitis C

• Over 33 years of use in many countries

• Available in 50 countries worldwide

• More than 17 million applications to date

• 3500+ publications in most surgical disciplines

Data on file, Baxter Healthcare

Tisseel Kit has 4 components

• 1 vial: Sealer protein lyophilized

concentrate.

• 1 vial: Lyophilized human thrombin.

• 1 vial: Aprotinin solution.

• 1 vial: Calcium chloride solution.

What's in it

• When reconstituted 1 ml of each solution contains:

• Human Fibrinogen: 72-110 mg in 96-125 mg protein, aprotinin (bovine) 3000 KIU/ml. Inactive ingredients include human albumin, L-Histidine, niacinamide, polysorbate 80 and sodium citrate.

• Human thrombin 5 or 500 IU, in 45-55

mg protein, calcium chloride 40

micromoles/ litre. Inactive ingredients

include human albumin and sodium

chloride.

• Human plasma pools are tested for presence

of genome sequences of HIV, HBV and HCV

• Tisseel is vapor-heated to inactivate viruses

• No evidence of disease transmission yet

• What about prions in Bovine aprotinin

Pharmacokinetics

• Tisseel is intended for epilesional use only.

• Intravascular pharmacokinetic studies have not been performed in humans.

• Fibrin sealants are metabolized in the same way as endogenous fibrin – fibrinolysis and phagocytosis.

Contraindications

• Not for intravascular use. Carries a high risk of thromboembolic complications.

• Remember it has a bovine protein (aprotinin) : risk of anaphylactic reaction.

• Risk is slightly higher in cases of previous exposure.

CASE 2: POSTOP DISLOCATION OF CONJUNCTIVAL GRAFT

Eye, 2007

Fibrin Glue versus Sutures for attaching the Fibrin Glue versus Sutures for attaching the Conjunctival Autograft in Pterygium Conjunctival Autograft in Pterygium Surgery: A Prospective Observer Masked Surgery: A Prospective Observer Masked Clinical Trial Clinical Trial

Sathish Srinivasan FRCSEd, FRCOphthMichael Dollin MDPenny McAllum FRANZCOYoav Berger MDDavid S. Rootman MD, FRCSCAllan R. Slomovic MD, FRCSC

Table 1. Scoring parameters for each of the three Table 1. Scoring parameters for each of the three outcome variables outcome variables

Outcome Variables Scoring Parameters

Subconjunctival Hemorrhage

Grade 0: NoneGrade 1: ≤ 25% of the size of the graftGrade 2: ≤ 50% of the size of the graftGrade 3: ≤ 75% of the size of the graftGrade 4: Hemorrhage involving the entire graft (no subconjunctival

vessels visible)

Inflammation Grade 0: No dilated corkscrew vessel in the graftGrade 1: 1 bright red, dilated corkscrew vessel crossing the graft-bed marginGrade 2: 2 bright red, dilated corkscrew vessels crossing the graft-bed marginGrade 3: 3 bright red, dilated corkscrew vessels crossing the graft-bed marginGrade 4: ≥ 3 bright red, dilated corkscrew vessels crossing the graft-bed

margin

Graft Stability Grade 0: All 4 sides of the graft margin are well apposedGrade 1: Gaping/displacement of 1 side of the graft-bed junctionGrade 2: Gaping/displacement of 2 sides of the graft-bed junctionGrade 3: Gaping/displacement of 3 sides of the graft-bed junctionGrade 4: Graft completely displaced from the bed