Pacquet 2001.
| Methods | CCT | |
| Participants | University Medical Centre, Belgium 20 patients Inclusion criteria: adults with post‐surgical or post‐traumatic keloid scars Exclusion criteria: no previous scar treatment Sex: 2 male, 9 female in laser group; not stated for silicone gel group Age: 17 to 63 years for treatment group (no information available on controls) | |
| Interventions | 11 patients treated with 585 nm pulsed dye laser (1 to 3 treatments at 6 to 8‐week intervals) 9 patients (controls) with application of silicone gel sheeting | |
| Outcomes | Length of follow‐up: measurements made on 5 occasions at 3‐week intervals Clinical: erythema and melanin of scar Complications: none reported | |
| Notes | Size measured by ruler Erythema and melanin measured by spectrophotometer | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: no information is provided on random sequence generation which we judged to be at unclear risk of bias |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information is provided on the allocation concealment which we judged to be at unclear risk of bias |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: this study compared silicone gel sheeting with a flash lamp pumped pulse dye laser. Due to the nature of the intervention it was judged that participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Clinical assessment of treatment efficacy was supported by comparisons of photographs". Comment: no further information is given on the blinding of participants which we judged to be at unclear risk of bias. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Eleven adults presented with postsurgical or posttraumatic keloids". Comment: Figure 2 presents the results of all 11 patients therefore there was 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 |