| Methods |
When patients arrived in the operating suite an evelope was opened which contained details of the allocated treatment group (a computer‐generated random sequence was used). |
| Participants |
80 patients undergoing elective primary hip arthroplasty were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 33), M/F = 12/21, mean age (+/‐SD) = 67.1 (8.9) years.
(2) Control group (n = 36), M/F = 15/21, mean age (+/‐SD) = 63.1 (10.9) years.
NB: 11 patients randomised to the fibrin sealant group were excluded from the analysis as no fibrin sealant was applied during surgery as intended. Reasons for exclusion included: machine malfunctions, operator errors, not producing the fibrin on time, and forgetting to apply the sealant. |
| Interventions |
(1) Fibrin sealant group donated 120 ml of whole blood which was then processed peri‐operatively using the Vivostat® system to produce fibrin sealant. The Vivostat‐derived sealant was applied to the bleeding surgical wound surfaces after an appropriate attempt to dry the surface before application of Vivostat before closure, in an attempt to stop or prevent bleeding. The surgeons were asked to dry the surface to which the Vivostat was to be sprayed as much as possible before application.
(2) Control group received no fibrin sealant or additional haemostatic treatment. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Amount of allogeneic blood transfused (ml).
Blood loss (ml) ‐ intra‐operative.
Length of hospital stay (days).
Auto‐transfusion (n) ‐ cell salvage.
Haematoma (n). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated random sequence |
| Allocation concealment? |
High risk |
C ‐ inadequate (sealed envelopes) |
| Blinding?
All outcomes |
High risk |
Open‐label study |
