| Methods |
RCT (abstract); participants randomised (unclear if > 1 wound per person)
Funding: non‐industry funding ‐ authors worked for health care agency. Setting: unclear
Duration of follow‐up 8 weeks
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
36 participants with pressure ulcers. PU Stage: II, III and IV (proportions not stated) (PU classification: not stated)
Age: not stated. Duration of ulcer: not stated. Ulcer size: not stated
Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported
Comment: few details (abstract) |
| Interventions |
Group 1: protease‐modulating dressing ‐ Fibracol (90% collagen, 10% alginate (from suppliers' website)); n = 24. Grouped intervention category: protease‐modulating dressing
Group 2: alginate dressing ‐ Kaltostat; n = 12. Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8 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 ‐ no information. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded ('open label') and no evidence that outcome assessor was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Missing data: Group 1 ‐ 116 total enrolled, 80 evaluable and interim analysis on 36 (not stated). Group 2 ‐ 116 total enrolled, 80 evaluable and interim analysis on 36 (not stated)
i.e. missing data, but unclear |
| Selective reporting (reporting bias) |
High risk |
Inadequate – outcome included in methods section but not results |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis person (unclear if > 1 ulcer analysed) ‐ one ulcer implied (e.g. "participants stratified before randomisation according to pressure ulcer location and size") |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, not blinded
Comments: interim analysis ‐ but planned, so acceptable |
