| 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: person (unclear if > 1 ulcer analysed) |
| Participants |
76 participants with pressure ulcers. PU Stage: not stated (PU classification: not stated)
Age: not stated. Duration of ulcer: not stated. Ulcer size: mean 15 cm² overall
Wound characteristics at baseline: infection not reported; slough not reported; all wounds necrotic; exudate not reported
Comment: implies 1 ulcer per person; "multicentre good practice trial" |
| Interventions |
Group 1: hydrocolloid dressing ‐ Granuflex; n = 38. Grouped intervention category: advanced dressing
Group 2: iodine containing dressing ‐ povidone iodine soaked gauze (tulle impregnated with PI); n = 38. Grouped intervention category: antimicrobial 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 |
Unclear risk |
Unclear who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 2/38 (5%) (2 dropped out due to deterioration). Group 2 ‐ 5/38 (13%) (5 dropped out due to deterioration in the wound)
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear reporting |
| Other bias
unit of analysis |
Unclear risk |
Unit of randomisation person and unit of analysis person (unclear if > 1 ulcer analysed) ‐ probably 1 ulcer per person |
| Other bias
additional |
Unclear risk |
PU classification unclear |
| ALL‐DOMAIN RISK OF BIAS |
Unclear risk |
Rating: unclear
Comments: unclear selection bias, unclear whether ulcer or person is unit of analysis. Grade of PU not stated (but open necrotic pressure sores/ulceration) |
