Carney 1994.
| Methods | RCT | |
| Participants | Teaching Hospital, UK 42 patients Inclusion criteria: hypertrophic scars Exclusion criteria: no other scar‐reducing treatment in previous month Sex: not stated Age: 2 to 65 | |
| Interventions | Half assigned to receive Silastic Gel Sheeting and half Cica‐Care (untreated scar on same patient used as control) | |
| Outcomes | Length of follow‐up: measurements made at monthly intervals for 6 months, then follow up at 3 and 6 months after ceasing treatment Clinical: scar elasticity, appearance, colour Complications: mild irritation, pruritis | |
| Notes | Extensometric measurements made. Irritation rated by patient on scale of 0 to 5. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Forty‐two patients were randomly assigned to SGS and CC groups and their hypertrophic scars were divided into treated and control areas”. Comment: no further information was given on how control and treatment areas were selected |
| Allocation concealment (selection bias) | Unclear 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 | Quote: “The study took the form of an open, controlled trial.” 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: “Patients were required to attend a review clinic . . . at each visit the scar was photographed and the appearance of the treated and untreated area was assessed for state and colour . . . the extensibility of each scar was measured”. Comment: no further information was given on blinding of outcome assessor which we judged to be at unclear risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “Forty‐two patients were enrolled in the trial, with a total of 47 scars”. The authors go on to state “the results specifically relating the colour and texture of the scars after 2 months (28 patients) and 6 months (21 patients)”. Comment: no specific mention of loss to follow‐up in made in the study. Due to the quote above we judged the study to be at high risk of attrition bias.Absence of reported data in trial. |
| 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 of other sources of bias |