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. 2013 May 31;2013(5):CD009557. doi: 10.1002/14651858.CD009557.pub2

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:
  • modified radical mastectomy

  • quadrantectomy


Confounding interventions: none
Outcomes Primary:
  • mean duration of axillary drainage


Secondary:
  • mean total drainage volume

  • mean seroma aspirate volume

  • mean number of seroma aspirations

  • wound infection

  • postoperative complications

  • incidence of seroma

  • complications

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