Cipolla 2010.
Study characteristics | ||
Methods | Study design: prospective randomised controlled trial Randomisation technique: not reported Allocation concealment: inadequately reported Inclusion criteria: well explained Exclusion criteria: well explained Lost to follow‐up: not mentioned Baseline variables: matching between both limbs of the trial Intention‐to‐treat analysis: not reported Sample size calculations (power of the study): not reported | |
Participants | Country: Italy Number of participants: FG: 80 and NFG: 79 Mean age (years): FG 59.1 ± 13.93; NFG 58.8 ± 10.8 | |
Interventions | FG: Tissucol® was applied under skin flaps following breast and axillary surgery Types of surgical intervention:
Confounding interventions: none |
|
Outcomes | Primary:
Secondary:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not reported |
Allocation concealment (selection bias) | High risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not reported |
Selective reporting (reporting bias) | Low risk | No |
Other bias | Low risk | Inclusion, exclusion criteria, ethics approval and conflict of interest declaration was adequately reported |