Dinsmore 2000.
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: USA Number of participants: FG: 14 and NFG: 13 Mean age (years): FG 62.3 ± 2.1; NFG 64.5 ± 2.8 | |
Interventions | FG: Tissucol® was applied under skin flaps following breast and axillary surgery Types of surgical intervention
Confounding interventions: none |
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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 | 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 |