Randomized Clinical Trial for Fibrin Sealant in Knee Surgery

1. Introduction

• Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1. Within Sanquin there is a question whether fibrin sealant can be produced from the allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied whether allogenous single donor fibrin sealant produced using the CS-1 is effective in wound healing and as consequence of this can be registered as a product of Sanquin.
• The use of fibrin sealant will be studied in a prospective randomized trial for patients undergoing knee and hip replacements.

2. Aim

· To study the effectiveness of fibrin sealant produced of single donor allogeneic plasma when used intra-operatively after total knee or hip replacement.

• Primairy endpoint: wound healing.
• Secondary endpoints: total blood loss until 24h post-operative, amount of blood transfused, motion of the joint (knee) after surgery, amount of pain after surgery, use of antibiotics, wound infections, stay in hospital, adverse events, satisfaction with fibrin sealant as used by the physician.

3. Hypothesis

• We hypothesize that use of fibrin sealant will have a positive effect on wound healing, will cause less blood loss, decreased use of antibiotics and and will cause that a decreased number of infections will be seen compared to patients who are not treated with fibrin sealant. Through this, hospital stay will probably be shortened for patients who are treated with fibrin sealant.
• As a working hypothesis we assume a score for wound healing of at least 20% lower and at least 20% less blood loss for the fibrin sealant treated group.

4. Definitions

· N/A 5. Ethical aspects 5.1 Admission of the Ethical Committee · For this study approval is asked from the ethical committee of each participating hospital.