Niessen 1998.
| Methods | RCT | |
| Participants | 4 University Hospitals, Netherlands 155 patients Inclusion criteria: bilateral breast reduction surgery Exclusion criteria: not stated Sex: all female Age: 14 to 69 years | |
| Interventions | Scars covered with silicone sheet held in place with Micropore tape, either left lateral and right medial sides, or right lateral and left medial side of scars Untreated "control" part of scar supported with Micropore tape silicone was worn for 24 hours/day for 3 months | |
| Outcomes | Length of follow‐up: measurements made at 2 weeks, 3 months, 6 months and 12 months Clinical: width, height, blood flow and colour of scar, patient complaints about itching and pain Complications: skin irritation | |
| Notes | Width measured by ruler; height judged as either 1 normal, 2 hypertrophic, 3 keloid Patient complaints assessed on a 10‐point scale (1 = no complaints, 10 = very severe itching or pain) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “A total of 155 healthy women with a mean age of 31 (14 to 69) years participated in a prospective, randomised multicenter study”. 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 silicone materials were applied with a little stretch tension and fixated with Micropore to obtain a proper contact with the skin. For an equal support to both parts of the scar, the untreated side was applicated with Micropore alone”. 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: “To reduce observer variation, the first author examined all of the patients at follow‐up”. 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 | Low risk | Quote: “From the 155 treated patients, 36 did not complete the study: 18 in the group treated by Sil‐K and 18 in the group treated by Epiderm”. Comment: the reasons for loss to follow‐up are clearly documented in table 1. The numbers are the same in each group and reasons given seem valid. As a result we judged the study to be at low risk of bias despite the overall loss to follow‐up being 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 | Low risk | Comment: the study appears to be free from other sources of bias |