Gilly 1998.
Study characteristics | ||
Methods | Study design: prospective randomised controlled trial Randomisation technique: random allocation Allocation concealment: not 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: France Number of participants: FG: 50 and NFG: 58 Mean age (years): FG 60.6 ± 10.8; NFG 62.5 ± 11.5 | |
Interventions | FG: Tissucol® 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 | High risk | No declaration of ethics approval and conflict of interest |