Colom Majan 2006.
| Methods | RCT | |
| Participants | Special Sciences Institute, Spain 11 patients Inclusion criteria: adults > 18 years with postoperative scars Exclusion criteria: underlying relevant disease, known hypersensitivity to product used; inability to comply/attend follow‐up; keloid scar Sex: all female Age: 20 to 43 | |
| Interventions | silicone gel sheeting applied to 6 scars for 23 hours per day for a maximum of 1 week; 5 controls had no treatment | |
| Outcomes | Length of follow‐up: measurements made at monthly intervals for 6 months, then at 12 months Clinical: Vancouver scale for appearance; patient's rating of pain and itch Complications: local skin reaction | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “participants were randomly allocated to one of the two treatment options by a predetermined computer generated randomisation list”. Comment: participants were judged to be adequately randomised |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information on allocation concealment was given in the study which was judged to be at unclear risk |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Blinding was not possible as this was a dressing versus no dressing study”. Comment: the study was described as “an open randomised controlled clinical investigation”. 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 | Quote: “Eleven female patients were randomised and enrolled . . . ten participants completed the 12‐month investigation; one in the treatment group discontinued for personal reasons.” Comment: we judged attrition bias to be low |
| 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 | High risk | Quote: “This study was supported by Molnlycke Healthcare AB”. Comment: Molnlycke Healthcare AB was the brand of silicone gel used in the trial. We judged this to cause a high risk of bias. |