| Methods |
Method of randomisation and allocation concealment were not described. Blinding was not described. |
| Participants |
53 patients undergoing elective unilateral primary total knee arthroplasty with cement were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 25), M/F = 13/12, mean age (+/‐SD) = 68.5 (10.4) years.
(2) Control group (n = 28), M/F = 11/17, mean age (+/‐SD) age = 69.4 (8.7) years. |
| Interventions |
(1) Fibrin sealant group: following cementing of the joint and before tourniquet deflation and wound closure, 10 mls of the virally inactivated Quixil® (Omrix Biopharmaceuticals SA) was sprayed onto the raw surfaces of the exposed bone and soft tissue using a dual‐syringe spray device. Drains were then placed in situ.
(2) Control group: received standard treatment without the use of fibrin sealant. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ post‐operative 24 hours.
Haematoma (n).
Haemoglobin levels. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Method of randomisation was not reported |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
Unclear risk |
Not reported |