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

Segura‐Castillo 2005.

Study characteristics
Methods Study design: prospective randomised controlled trial
Randomisation technique: random allocation
Allocation concealment: adequate
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: Mexico
Number of participants: FG: 22 and NFG: 23
Mean age (years): FG 48.36 ± 8.9; NFG 52.87 ± 9.74
Interventions FG: Quixil TM was applied under skin flaps following breast and axillary surgery
Types of surgical intervention:
  • modified radical mastectomy

  • axillary dissection


Confounding interventions:
  • none

Outcomes Primary:
  • seroma incidence


Secondary:
  • wound infection

  • length of seroma drainage in days

  • postoperative complications

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers
Allocation concealment (selection bias) Low risk Reported
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