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. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3

Cruz‐Korchin 1996.

Methods CCT
Participants Teaching Hospital, USA
 20 patients (40 scars)
 Inclusion criteria: bilateral McKissock reduction mammaplasties
 Exclusion criteria: not stated
 Sex: all female
 Age: not stated
Interventions Pre‐cut silicone elastomer sheet worn for 12 hours/day for 2 months (untreated adjacent scar on opposite breast of same patient used as control)
Outcomes Length of follow‐up: measurements made at 2 months; follow‐up at 6 months
 Clinical: scar hypertrophy
 Complications: transient rash in 1 patient, minor skin maceration in 1 patient
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Half the patients used the sheet on the breast that corresponded to her dominant hand and the other half used the sheet on their non dominant side”.
Comment: no method of randomisation was used in the study
Allocation concealment (selection bias) High risk Comment: no method of allocation concealment was used in the study
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no further information is provided on blinding. Due to the nature of the treatment, we judged that participants and personnel could not be blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: no further information was given on blinding of outcome assessor which we judged to be at unclear risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: 20 patients were enrolled in the study and table 2 in the results section gives outcomes for all 20 patients at 6 months follow up. Attrition bias was judged to be low risk.
Selective reporting (reporting bias) Low risk Comment: the study protocol was not sought, however all measurements discussed in the methods are reported in the results and clinically meaningful outcomes presented.
Other bias Low risk Comment: the study appears to be free of other sources of bias