Tan 1999.
| Methods | CCT | |
| Participants | National Skin Centre, Singapore 20 patients (60 keloid scars) Inclusion criteria: adults with multiple keloid scars (acquired at least 2 years ago) located on the same anatomic site Exclusion criteria: not stated Sex: 18 male, 2 female Age: 19 to 40 | |
| Interventions | 3 scars on each subject: 1 scar as control (no treatment), 1 received silicone gel sheet, 1 injected with triamcinolone acetonide (40 mg/ml) at intervals of 4 weeks | |
| Outcomes | Length of follow‐up: measurements made at 4, 8 and 12 weeks Clinical: scar length, width, height; change in colour and texture; improvement in the symptoms of pain and/or pruritis Complications: none | |
| Notes | Clinical photographs were taken at baseline and at week 12 Patients rated pain/pruritis using a 5‐point scale 2 physicians recorded changes at each visit | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “In each patient, three keloids of similar size were selected. One was assigned to no treatment (control) and one to each active treatment”. Comment: no further information is given on the method of randomisation used in the study |
| Allocation concealment (selection bias) | Unclear risk | Comment: no method of 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: “In each patient, three keloids of similar size were selected. One was assigned to no treatment (control) and one to each active treatment. The first acted as control and was not given any treatment, the second was treated with occlusive silicone gel sheeting and the third was treated with intralesional injections”. 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 | Unclear risk | Quote: “Clinical assessment was carried out by both the physician and patient”. Comment: no further information was given regarding outcome assessment which we judged to be at unclear risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “Of the 20 patients, 17 completed the 12 weeks of treatment. Three patients were dropped from the trial (one defaulted from follow up and two defaulted from the treatment plan)”. Comment: overall loss to follow‐up was less than 20% and therefore judged to be a low risk of bias |
| 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 |