Gold 2001.
| Methods | RCT | |
| Participants | Gold Skin Care Centre, USA 96 patients Inclusion criteria: dermatologic surgery patients, 2 groups: Low‐risk (no history of abnormal scarring); high‐risk (significant history of abnormal scarring) Exclusion criteria: not stated Sex: low‐risk group 30 male, 20 female; high‐ risk group 9 male, 37 female Age: 36.7 years (mean) | |
| Interventions | Random allocation to receive either silicone gel sheeting (minimum of 12 hours/day for 6 months) applied at 48 hours post surgery, or routine postoperative care (control group) | |
| Outcomes | Length of follow‐up: measurements made at 2, 4, 8, 12, 16, 20 and 24 weeks Clinical: patient's opinion, physician observations, scaled photographic analysis Complications: none reported | |
| Notes | Patient's opinion of the site was assessed in terms of discomfort, embarrassment, colour, height, texture and function and was recorded on a 4‐point scale | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “the patients were randomised to receive either silicone gel sheet postoperatively or routine postoperative care”. 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: “the patients were randomised to receive either silicone gel sheet postoperatively or routine postoperative care” 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: "Assessments were made by physician observations of the site, patient opinions and scaled photographic analysis". 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: “Ninety‐six patients entered the trial during the enrolment period. During the course of the study 19 patients from the low‐risk group and 11 from the high‐risk group were lost to follow up or withdrew before the 2‐month inspection could be made. That left 66 patients or 69% of the original group available for analysis”. Comment: we judged attrition bias to be high as loss to follow‐up was greater than 20% |
| 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 | High risk | Quote: “This research was supported by Smith & Nephew, Largo, FL”. Comment: Smith & Nephew was the brand of silicone gel used in the trial. We judged this to cause a potentially high risk of bias. |