| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: not stated. Setting: care home and outpatients
Duration of follow‐up 12 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
41 participants with pressure ulcers. PU Stage: III (55% and 52%) or IV (PU classification: not stated)
Age: mean (SD): 77.0 (11.5) years and 74.1 (13.8) years. Duration of ulcer: not stated. Ulcer size: mean (SD): 12.1 (18.2) cm² and 11.0 (9.5) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: one ulcer evaluated per person |
| Interventions |
Group 1: hydrocolloid with or without alginate ‐ DuoDERM with or without Sorbasan: calcium alginate filler given as needed if the wound was highly exudative. Dressing changed every 7 d; n = 20. Grouped intervention category: advanced dressing
Group 2: ineligible intervention ‐ radiant heat (dressing change every 7 d); n = 21. Grouped intervention category: ineligible ‐ radiant heat |
| Outcomes |
Primary outcomes: proportion completely healed at 12 weeks; time to complete healing reported (Kaplan Meier plot included) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation adequate ‐ computer‐generated. Allocation concealment unclear ‐ "opaque envelopes". Baseline comparability adequate ‐ no suggestion of problems. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded to interventions – deduced from interventions |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 4/20 (20%) (1 died, 3 hospitalised). Group 2 ‐ 6/21 (29%) (2 died, 2 hospitalised, 2 dropped out for non‐study‐related reasons)
i.e. similar rate missing in both groups; high rate ‐ comparable with 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) ‐ unclear if selected |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Reasons: unclear selection bias, not blinded, attrition bias
Comments: outcome assessed at each visit after removing dressing ‐ not blinded |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
