| Methods |
RCT (abstract); not stated randomised (unclear if > 1 wound per person)
Funding: not stated. Setting: not stated
Duration of follow‐up 12 weeks
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
74 participants with pressure ulcers. PU Stage: 3 (PU classification: NPUAP)
Age: not stated. Duration of ulcer: mean (SD): 71 (59) weeks and 84 (139) weeks. Ulcer size: mean (SD): 8.1 (76.1) cm² and 9.8 (12.5) cm²
Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported
Comment: debridement throughout trial |
| Interventions |
Group 1: combination intervention ‐ "primary nonadherent silicone dressing and foam dressing"; n = 44. Grouped intervention category: advanced dressing
Group 2: ineligible intervention ‐ skin substitute (Apligraf (bilayered living cell‐based treatment)); n = 30. Grouped intervention category: ineligible ‐ skin substitute |
| Outcomes |
Primary outcomes: proportion completely healed at 12 weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation unclear ‐ “randomised”. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Missing data: Group 1 ‐ none stated. Group 2 ‐ none stated
i.e. unclear if data missing; unclear rate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Unclear risk |
Unit of randomisation not stated and unit of analysis person (unclear if > 1 ulcer analysed) ‐ implies 1 per person |
| Other bias
additional |
Unclear risk |
Unclear if the trial was stopped early because of the results |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, possibly terminated early, unclear blinding and attrition ‐ abstract.
Comments: conclusions say "although this study was terminated early… trials of longer duration are required". It is unclear if this means the trial was stopped early because of the results. Baseline difference in ulcer size and duration (larger for the bilayer) |
