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

Vaxman 1995.

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 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: France
Number of participants: FG: 20 and NFG: 20
Age (years): FG 55.6 ± 12; NFG 56.2 ± 10
Interventions FG: Tisseel®was applied under skin flaps following breast and axillary surgery
Types of surgical intervention:
  • modified radical mastectomy

  • lumpectomy


Confounding interventions:
  • pressure dressing

  • shoulder physiotherapy

Outcomes Primary:
  • incidence of seroma


Secondary:
  • postoperative complications

  • length of seroma drainage in days

  • mean volume of seroma

  • total volume of seroma

  • length of hospital stay

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) High risk Missing data on secondary variables
Other bias High risk No declaration of conflict of interest and ethics approval