Langer 2003.
Study characteristics | ||
Methods | Study design: prospective randomised controlled trial Randomisation technique: random allocation Allocation concealment: inadequate 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): not reported | |
Participants | Country: USA Number of participants: FG: 26 and NFG: 29 Mean age (years): FG 60.8 ± 7.3; NFG 56.3 ± 11.8 | |
Interventions | FG: Tisseel® was applied under skin flaps following breast and axillary surgery Types of surgical intervention:
Confounding interventions:
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Outcomes | Primary:
Secondary:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Participants were allocated randomly to both arms of the trial |
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. |