| Methods |
Randomized controlled clinical study |
| Participants |
One hundred and eighty patients undergoing lobectomy, wedge and segmental resections by open thoracotomy. Eight patients were excluded because they were pilot patients. One hundred and seventeen were assigned to the treatment group. Fifty‐five patients were assigned to the control group |
| Interventions |
A) Interventional group: Standard surgical treatment ; a synthetic sealant (Focal Seal) was applied to all sites of surgical manipulation. B) Control group: standard surgical treatment with no additional fibrin glue |
| Outcomes |
Primary: Percentage of patients free of air leakage throughout hospitalization. Secondary: control of air leaks intraoperatively, time to postoperative air leak cessation, time to chest tube removal, time to hospital discharge and safety outcomes |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "The patients were then randomized within their risk stratum by opening one or two sealed envelopes.The envelopes were randomly sequenced by computer" |
| Allocation concealment? |
Low risk |
Quote: "The patients were then randomized within their risk stratum by opening one or two sealed envelopes" |
| Blinding?
All outcomes |
Low risk |
Quote: "Evaluation and recording of chest tube output was handled by the nursing and physician staff at the bedside who were blinded to the randomization status of the subject" |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Criteria of exclusion and outcomes were reported |
