Bjelović 2018.
| Study characteristics | ||
| Methods | Study design: randomised trial Follow‐up: 90 days from date of surgery |
|
| Participants | Setting: multicentre (Hungary, Serbia, Spain, USA) Number randomised: 325 |
|
| Interventions | Intervention: Fibrin Sealant Grifols (n = 163)
Control: oxidised cellulose sheets (Surgicel; n = 162) |
|
| Outcomes | Primary outcome: proportion of participants who achieved haemostasis at the target bleeding site by 4 minutes without rebleeding until completion of surgical closure. Rebleeding was defined as bleeding from the target bleeding site requiring a further haemostatic intervention after haemostasis was previously achieved. Secondary outcomes
|
|
| Notes | 9 participants discontinued the study (Fibrin Sealant Grifols n = 5, Surgicel n = 4), with reasons not specified. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation software. |
| Allocation concealment (selection bias) | Low risk | Randomisation software. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel not blinded to outcome. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants and personnel not blinded to outcome. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Adequate follow‐up and outcome data provided. |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes were reported, and reasons for exclusion stated. |
| Other bias | Low risk | No other bias identified. |