Uden 1993.
Study characteristics | ||
Methods | Study design: prospective randomised controlled trial Randomisation technique: random allocation Allocation concealment: reported Inclusion criteria: well explained Exclusion criteria: well explained Lost to follow‐up: not reported Baseline variables: matching between both limbs of the trial Intention‐to‐treat analysis: not reported Sample size calculations (power of the study): reported | |
Participants | Country: Sweden Number of participants: FG: 36 and NFG: 32 Age (years): FG 73 (42‐89); NFG 70 (40‐84) | |
Interventions | FG: Tisseel®was applied under skin flaps following breast and axillary surgery Types of surgical intervention:
Confounding interventions:
|
|
Outcomes | Primary:
Secondary:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation |
Allocation concealment (selection bias) | High risk | No clear reporting |
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 |