| Methods |
RCT (abstract); participants randomised (unclear if > 1 wound per person)
Funding: industry funded ‐ Molnlycke Health Care sponsored the study. Setting: not stated
Duration of follow‐up 8 weeks
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
11 participants with pressure ulcers. PU Stage: II only (no subcutaneous involvement) (PU classification: not stated)
Age: mean 87.7 years and 88.2 years; 75 years and over. Duration of ulcer: more than 1 month. Ulcer size: not stated
Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported |
| Interventions |
Group 1: topical ‐ enamel matrix protein; n = 6. Grouped intervention category: enamel matrix protein
Group 2: topical ‐ propylene glycol alginate (vehicle ‐ propylene glycol alginate); n = 5. Grouped intervention category: propylene glycol alginate |
| 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 ‐ baseline difference but unclear of importance. 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 ‐ 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 person and unit of analysis person (unclear if > 1 ulcer analysed) ‐ implies 1 per person |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, not blinded
Comments: comparable in age, more women in control group |
