Kelemen 2007.

Methods	RCT
Participants	24 participants were drawn on the basis of pre‐determined criteria from a pool of 200 patients with linear hypertrophic wounds.8 men, 16 women; mean age 43 years (range 17 to 67). Inclusion criteria: active hypertrophic scar on a smooth anatomic site (for easy application of silicone sheet) Exclusion criteria: diabetes, immune and autoimmune diseases, any local or systemic steroid or non steroid treatment Study location: Baranya Megyei Korhaz (Hospital) – Medical University of Pecs, Hungary
Interventions	24 patients were then randomly allocated to a treatment (n = 12) and a control (n = 12) group Treatment 1 (intralesional steroid group): injection of 10% solution of triamcinolone acetate (producer: Krka, Slovenia) using 1 ml/cm² with a ‘linear’ technique. The vial contains 40 mg active ingredient per 1 ml solution. For dilution 2% lidocaine (producer: Egis, Hungary) was used. Local anaesthetic was applied to ease the discomfort caused by the injection. The injection needle size varied between 12 and 19G according to the hardness of the scar. Treatment 2 (silicone sheet group): patients wore an appropriate size (exceeding the periphery of the scar by 2 cm in all directions) silicone sheet for 12 hours per day intermittently. They patients received training about how to use the sheets and used sheets were replaced. There were 2‐weekly check‐ups to measure progress.
Outcomes	Change in total score using Vancouver scar scale, subjective patient experience according to a 5‐point Likert scale
Notes	Digital photographs used for scoring scar. The intralesional injection group was treated by health professionals whilst the silicone gel sheeting group was instructed how to apply the product themselves.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	24 participants were drawn on the basis of pre‐determined criteria from a pool of 200 patients with linear hypertrophic wounds who were treated between April 2001 to March 2004. These 24 patients were then randomly allocated to treatment 1 (n = 12) or treatment 2 (n = 12), but method unclear.
Allocation concealment (selection bias)	High 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	No blinding took place
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding took place
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Outcomes not well presented, only a couple of examples shown
Selective reporting (reporting bias)	High risk	Yes. Only 1 ‘interesting’/’unusual’ case from each group reported. There is not a lot of information about outcomes comparing the 2 groups. The authors only state that the intralesional steroid injection was more effective, worked faster and reduced subjective symptoms a lot quicker than the silicone gel. There are no statistical tables to show the progression and difference between the 2 groups week by week. There is one chart showing how Vancouver points change across the two groups for every 2 weeks.
Other bias	Low risk	Comment: the study appears free from other sources of bias