| Methods |
RCT (abstract); participants randomised (unclear if > 1 wound per person)
Funding: not stated. Setting: not stated
Duration of follow‐up 8 weeks
Unit of analysis: unclear |
| Participants |
12 participants with pressure ulcers. PU Stage: 2 and 3 (proportions not stated) (PU classification: EPUAP)
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 |
| Interventions |
Group 1: hydrogel dressing ‐ DuoDERM Hydrogel (not in BNF): with OpSite Flexigrid secondary dressing; n = 6. Grouped intervention category: advanced dressing
Group 2: topical ‐ tripeptide‐copper gel + OpSite; n = 6. Grouped intervention category: tripeptide‐copper |
| 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 |
Unclear risk |
Unclear who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Missing data: Group 1 ‐ 0 (implied). Group 2 ‐ 0 (implied)
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 unclear ‐ 1 ulcer per person implied |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
Unclear risk |
Rating: unclear
Reasons: unclear selection bias, unclear attrition, unclear blinding (abstract); preliminary results
Comments: abstract ‐ few details |