Skip to main content
. 2013 May 31;2013(5):CD009557. doi: 10.1002/14651858.CD009557.pub2

Gilly 1998.

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 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: France
Number of participants: FG: 50 and NFG: 58
Mean age (years): FG 60.6 ± 10.8; NFG 62.5 ± 11.5
Interventions FG: Tissucol® was applied under skin flaps following breast and axillary surgery
Types of surgical intervention:
  • modified radical mastectomy

  • sector mastectomy


Confounding interventions:
  • pressure dressing

  • shoulder physiotherapy

Outcomes Primary:
  • incidence of seroma


Secondary:
  • length of hospital stay

  • postoperative complications

  • total seroma volume

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 High risk No declaration of ethics approval and conflict of interest