| Methods |
Randomisation was determined according to patient number, which had been assigned with a computer‐generated randomisation list. Randomisation was centralised. |
| Participants |
58 patients undergoing elective total knee arthroplasty were randomly divided into 1 of 2 groups:
(1) Fibrin sealant group (n = 29), M/F = 6/23, mean age (+/‐SD) age = 68.9 (6.3) years.
(2) Control group (n = 29), M/F = 6/23, mean age (+/‐SD) age = 70.2 (8.2) years. |
| Interventions |
(1) Fibrin sealant group received 10 to 20 ml of Quixil® (octacol F15, Omrix Biopharmaceuticals) applied by topical spraying with the use of a double‐syringe spray‐device. The FS was sprayed over the tissues, into the joint itself, on the raw surfaces of the bones, on the muscles and tendons, and around the subcutaneous tissues.
(2) Control group received no FS treatment. Conventional haemostatic measures were used.
NB: All operations were performed in a bloodless field with the use of a pneumatic tourniquet. Electrocautery of the major vessels was performed. The entire operative field was thoroughly rinsed of any debris and was meticulously dried. Drains placed insitu were connected to high‐vacuum suction drains. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ apparent blood loss ‐ post‐operative drainage.
Blood loss (ml) ‐ total estimated post‐operative blood loss.
Mortality (n).
Fever (n).
Infection (n).
Reduction in Hb and Hct levels.
Haematoma development (n). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated randomisation list |
| Allocation concealment? |
Low risk |
A ‐ Adequate (central randomisation) |
| Blinding?
All outcomes |
High risk |
Blinding was not adequate |
