Sproat 1992.
| Methods | RCT | |
| Participants | Teaching Hospital, Canada 14 patients Inclusion criteria: adults with symptomatic hypertrophic sternal scars after cardiac surgery Exclusion criteria: not stated Sex: 7 females, 7 males Age: 33 to 81 years | |
| Interventions | Matched design ‐ scar divided into halves (upper and lower) each receiving a different treatment: Half injected with Kenalog silicone gel sheet applied to other half for 12 hours/day for 12 weeks | |
| Outcomes | Length of follow‐up: measurements made weekly for 12 weeks Clinical: scar length, width, height measured by a blinded observer Photographs taken before and after Patient symptoms and rating of pain of injection Patient treatment preference Complications: Kenalog: skin atrophy, white bead‐like skin deposits, pigmentary changes; silicone: rash | |
| Notes | Patient treatment preference elicited at the end of the trial Photographs evaluated by 5 independent observers | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Fourteen poststernotomy cardiac patients were randomised to treatment in one half of the scar with Kenalog injection. Simultaneously the other half of the scar received the silicone gel sheet”. 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 we judged to be at unclear risk |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Fourteen poststernotomy cardiac patients were randomised to treatment in one half of the scar with Kenalog injection. Simultaneously the other half of the scar received the silicone gel sheet”. 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 | Low risk | Quote: “Photographs of the scars were taken before and after the treatments and were evaluated by five independent observers at 12 weeks. Measurements of the scar were taken by a blindfolded observer”. Comment: as measurements of the scar were taken by a blindfolded observer we judged the outcome assessor to be blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “this trial was stopped when 11 patients had completed the treatment”. Comment: as a result of the above quote it was judged that no patients were lost 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 to be free from other sources of bias |