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

Ko 2009.

Study characteristics
Methods Study design: prospective randomised controlled trial
Randomisation technique: web‐based
Allocation concealment: adequate
Inclusion criteria: well explained
Exclusion criteria: well explained
Lost to follow‐up: adequate
Baseline variables: matching between both limbs of the trial
Intention‐to‐treat analysis: reported
Sample size calculations (power of the study): reported
Participants Country: South Korea
Number of participants: FG: 50 and NFG: 50
Mean age (years): FG 48.5 ± 8.7; NFG 47.9 ± 7.7
Interventions FG: Greemplast Kit® was applied under skin flaps following breast and axillary surgery
Types of surgical intervention:
  • lumpectomy


Confounding interventions:
  • compression for 5 days

Outcomes Primary:
  • incidence of seroma


Secondary:
  • mean volume of seroma

  • postoperative complications

  • wound infection

  • total volume of seroma

  • mean number of drainage days

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Web based
Allocation concealment (selection bias) Low risk Adequate
Blinding of participants and personnel (performance bias)
All outcomes Low risk Adequate
Blinding of outcome assessment (detection bias)
All outcomes Low risk Adequate
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