Momeni 2009.
| Methods | RCT | |
| Participants | 38 patients with hypertrophic burn scars: 16 male, 22 female; median age 22 years (1.5 to 60 years) Inclusion criteria: no history of keloid formation; healed, homogeneous burn scar of at least 5 cm by 5 cm in area Exclusion criteria: wound infection; open wound; sensitivity to silicone gel Study location: Iran University of Medical Sciences |
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| Interventions | silicone gel sheeting (Cica‐Care) or a placebo (self adhesive propylene glycol and hydroxyethyl cellulose sheeting): both applied for 4 hours/day with a 4‐hourly daily increment to 24 hours/day (overlay taping also used as required) Each treatment applied to either half of one scar Treatment commenced 2 to 4 months after injury; exact duration of silicone sheet application not stated (recommendations of 12 to 24 hours/day are discussed only) |
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| Outcomes | Pigmentation; vascularity; pliability; pain; itchiness (according to a modified version of the Vancouver scar scale excluding height) Assessment at 1 and 4 months (4 patients lost to follow‐up) |
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| Notes | Front and profile views of wound changes recorded using a digital camera by a 'blind' evaluator | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A random number table was used for the coding and randomisation of the gel and placebo samples". Comment: randomisation was judged to be adequate |
| 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 | Unclear risk | Comment: patients were blinded using placebo sheets; blinding of personnel not possible due to nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "each participant was sent to another plastic surgeon for the wound to be evaluated blindly." Comment: assessors likely blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Four participants were lost to follow‐up (two because of distance and two because of failure respond)." Comment: loss to follow‐up is low and reasons given seem valid. 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 | Low risk | Comment: the study appears free from other sources of bias |