| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: not stated. Setting: hospital inpatients
Duration of follow‐up 4 (30 days) weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
60 participants with pressure ulcers. PU Stage: II/III (acceptable); 71% and 79% Stage II (PU classification: Stirling)
Age: median 74 years and 73 years. Duration of ulcer: not stated. Ulcer size: < 5 cm² (32% and 48%), 5 to < 10 (19% and 21%), 10 to < 20 (29% and 14%), > 20 (19% and 17%)
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate low‐moderate levels
Comment: same number of ulcers as participants in table; exudate: none (32% and 28%), slight (58% and 31%), moderate (10% and 41%); 5‐centre trial |
| Interventions |
Group 1: hydrocolloid dressing ‐ Granuflex; n = 31. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Allevyn Adhesive; n = 29. Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 4 (30 days) weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
High risk |
Sequence generation unclear ‐ not stated. Allocation concealment inadequate ‐ evidence that researchers knew the sequence. Baseline comparability inadequate ‐ baseline characteristics different between arms. Rating: high |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Other evidence for no blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 22/31 (71%) withdrew (8 discharged, 2 died, 2 adverse incident, 2 participant request, 2 dressing unsuitable, 2 wound deteriorated, 1 lack of progress, 2 dressing rolling). Group 2 ‐ 18/29 withdrew (62%) (5 discharged, 6 died, 3 adverse incident, 2 participant request, 1 dressing unsuitable, 1 wound deteriorated)
i.e. similar rate missing in both groups; high rate – more than control event rate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis person (1 ulcer/person) |
| Other bias
additional |
Low risk |
The study appears to be free of other sources of bias |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Comments: allocation concealment inadequate ‐ "allocated sequentially using an open randomisation list"; ulcer size larger for hydrocolloid group. Not blinded: performance assessed at dressing change; attrition bias |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
