Palmieri 1995.
| Methods | RCT | |
| Participants | University trial, Italy 80 patients Inclusion criteria: adults with hypertrophic and keloid scars Exclusion criteria: psychological disturbance Sex: both; numbers not stated Age: 18 to 63 years | |
| Interventions | Random allocation to 2 groups: Scars covered with silicone plates with added vitamin E (5 g) Or Scars covered with silicone gel sheet Both worn for 10 hours/day (overnight) and fixed with tape | |
| Outcomes | Length of follow‐up: measurements made at 4 and 8 weeks Clinical: Scott‐Huskisson Scale (for pain and itching) Photography of front and side of scar ‐ evaluated on colour, size, cosmetic appearance Complications: none reported | |
| Notes | Scoring of scar appearance on a scale of 0 to 5; itching and pain recorded by patients on Scott‐Huskisson scale | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Patients were randomized in a simple blind study, into two groups”. Comment: no further information was given on how patients were randomised |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment was given in the study which we judged to be at unclear risk |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: the study is described as simple blind. The intervention in this case was silicone gel sheeting with vitamin E versus silicone gel sheeting therefore it is likely that the participants were blind but the research personnel were not. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “Photographs were taken with identical frontal side views of the scar at the beginning and end of the trial and compared in terms of colour, size and cosmetic appearance of the scar and scored between 0 and 5". 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 | Quote: “No drop‐out was observed due to intolerance of the wearing overnight of the silicone plate”. Comment: no loss to follow‐up. |
| 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 from other sources of bias |