Li‐Tsang 2006.
| Methods | RCT | |
| Participants | 45 Chinese patients Inclusion criteria: history of burns, scald or severe skin trauma resulting in hypertrophic scar Exclusion criteria: age > 50 years, scar > 20 cm² or < 3 mm thickness Sex: 29 male, 16 female Age: 29.65 years (mean) | |
| Interventions | Random allocation to receive either silicone gel sheeting (24 hours/day for 6 months) + 15‐minute lanolin deep massage twice a day versus lanolin massage only | |
| Outcomes | Length of follow‐up: measurements made at 1, 2, 4 and 6 months Clinical: scar pigmentation, thickness, Vancouver scale for appearance, patient's rating of pain and itch | |
| Notes | Colour and thickness measured with spectrocolorimeter and Tissue Ultrasound Palpation System (TUPS) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Forty‐five subjects were randomly allocated into the silicone gel sheeting group (SGS group) and the control group (MT group)”. 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 | Quote: “Twenty‐two subjects were placed in the experimental group with silicone gel sheeting (SGS) applied 24 h per day for 6 months while all subjects were taught to massage the scar daily for 15 min serving as the control intervention”. Comment: 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 | Low risk | Quote: “the assessment was conducted by a research assistant who was blind to the subject grouping and was trained to administer all the assessments in standardized methods”. Comment: we judged the outcome assessor to be adequately blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “There were 24 subjects allocated to the silicone gel sheeting (SGS) group and 21 subjects in the control (MT) group. Three subjects from the control group have dropped out due to long travelling incurred for reassessment". Comment: we judged attrition bias 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 | High risk | Quote: “We would also like to thank Smith and Nephew (HK) Company Limited for their generous support to provide all the silicone gel sheeting (Cica‐Care) for our study". Comment: Smith & Nephew was the brand of silicone gel used in the trial. We judged this to cause a high risk of bias. |