Karagoz 2009.
| Methods | RCT | |
| Participants | 32 patients (45 hypertrophic post‐burn scars): 12 men, 20 women; mean age 24 years Scar locations: head and neck (4 scars); upper limb (29 scars); lower limb (3 scars) and trunk (9 scars) Inclusion criteria: hypertrophic post‐burn scar; age of scar < 6 months Exclusion criteria: hypertrophic post‐burn scar due to chemical burns; age of scar > 6 months |
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| Interventions | Random allocation to one of 3 groups (15 scars in each): Group 1; silicone gel (Scarfade) applied twice daily Group 2: silicone gel sheet (Epiderm) applied 24 hours (except during bathing) Group 3: topical onion extract including heparin and allantoin (Contractubex) applied twice daily (Also using Tubigrip, an elasticated tubular bandage, was recommended to all patients in the study) Duration of treatments: 6 months Study location: Haydarpasa Training Hospital, Istanbul, Turkey |
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| Outcomes | Scar assessment using the Vancouver scar scale (assessing response to treatment on a 4‐point Likert scale): 'excellent' if scar change of 7 or more points; 'good' if scar change of 4 to 6 points; minimal response if scar change of one to 3 points; and 'no response' for no scar change Outcomes assessed on Vancouver scar scale: scar pigmentation; vascularity; liability; height before and after treatment Follow‐up: monthly when scars photographed |
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| Notes | 2 patients in silicone gel sheet group (Group II) disrupted treatment for 1 week due to skin maceration and pruritis; all patients in Group II tolerated silicone gel sheet for at least 12 hours daily. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients with scars less than 6 months of age were assigned at random to three groups each containing 15 scars, and their treatment were continued for 6 months". 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: "Scars were treated with silicone gel in group I, silicone gel sheet in group II, and topical onion extract including heparin and allantoin in group III". 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 | High risk | Quote: "Scar assessments were performed at the beginning of the treatment, and at the end of the sixth month when the treatment was completed by the same physician" Comment: we judged the study to be at high risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: the CONSORT diagram in table 3 shows 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 free from other sources of bias |