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 |