| Methods |
Single‐blind, prospective, randomised, parallel‐group, multicentre, Phase III FDA‐monitored (US Food and Drug Administration) trial conducted in the US (six sites) and the UK (three sites). Patients were randomised following an intention‐to‐treat protocol.Randomisation was performed using permuted blocks of variable size and stratified by the surgeon. Treatment assignment was intra‐operative and was revealed as late as possible by use of sealed envelopes. The investigational fibrin sealant was prepared in the operating room before the patient's assignment was revealed in order to prevent delay in its application and permit maintenance of the blinding for as long as possible. |
| Participants |
81 patients undergoing elective total hip replacement were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 38), M/F = 22/16, mean age (+/‐SD) = 66.9 (11.5) years.
(2) Control group (n = 43), M/F = 23/20, mean age (+/‐SD) = 67.8 (10.6) years. |
| Interventions |
(1) Fibrin sealant group received a total of 10 ml of fibrin sealant sprayed onto the exposed tissue at 3 predetermined stages of the procedure. Routine haemostatic techniques such as cauterisation and suture ligation were used until the femoral neck was osteotomised, the acetabular exposure was carried out, and the deep acetabular retractors were placed. Approximately 4 ml of the investigational fibrin sealant was then sprayed onto the whole wound. Another 4 ml of FS was sprayed primarily onto the deep tissues around the acetabulum after the acetabular component was inserted, any acetabular osteophytes were removed, and all peri‐acetabular soft tissue resection was completed. The final 2 ml of FS was sprayed after any deep repair but before closure of the fascia.
(2) Control group received standard (usual) care with no fibrin sealant. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ intra‐operative/post‐operative estimated blood loss.
Blood loss (ml) ‐ total estimated blood loss.
Length of hospital stay (days).
Anaemia (n).
Seroconversion (n).
Change in Hb level. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Method of randomisation was not reported |
| Allocation concealment? |
High risk |
C ‐ Inadequate (sealed envelopes) |
| Blinding?
All outcomes |
Unclear risk |
Not reported |
