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

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:
  • modified radical mastectomy

  • sector mastectomy

  • axillary dissection


Confounding interventions:
  • reduced shoulder mobilisation

Outcomes Primary:
  • incidence of seroma


Secondary:
  • drainage days

  • total seroma volume

  • wound infection

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.