| Methods |
At the conclusion of the resection patients were randomly assigned in the operating room to control or treatment group in a 1:1 ratio by opening a sealed envelope. Upon arrival in the recovery room each patient was assessed by the blinded observer. During the subsequent 48 hours the blinded observer recorded the data every 8 hours. The method used to generate random sequences was not described. |
| Participants |
100 patients undergoing elective lobar and wedge pulmonary resections were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 50), M/F = 25/25, mean age (range) = 68 (52 to 85) years.
(2) Control group (n = 50), M/F = 23/27, mean age (range) = 66 (20 to 87) years. |
| Interventions |
(1) Fibrin sealant group received an application of 5 ml of fibrin glue using the HemaMyst® system. A fine aerosolised mist spray of fibrin glue was applied. Raw and stapled lung surfaces were sprayed with a portion of the fibrin glue. This spray was followed by the application of fibrin glue to the mediastinal lymph node bed when applicable and then spraying the remainder of fibrin glue on the dissected or stapled lung and bronchial stump.
(2) Control goup did not receive fibrin sealant treatment. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ 24 hours post‐operative.
Wound infection (n).
Length of hospital stay (days).
Prolonged air leaks (n).
Alveolar air leaks (n).
Empyema (n). |
| 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 were used) |
| Blinding?
All outcomes |
Low risk |
Outcomes assessed blind |
