| Methods |
RCT; participants randomised (> 1 wound per person, largest selected)
Funding: not stated. Setting: care home and outpatients
Duration of follow‐up 8 weeks
Unit of analysis: person (selected ulcer) |
| Participants |
40 participants with pressure ulcers. PU Stage: II (11 and 15%) and III (PU classification: AHCPR)
Age: mean (SD): 76.7 (19.5) years and 75.7 (18.6) years. Duration of ulcer: median: 10 weeks and 9 weeks. Ulcer size: mean(SD): 4.61 (5.56) cm² and 6.84 (8.19) cm²
Wound characteristics at baseline: no wounds infected; some wounds sloughy; necrosis not reported; exudate not reported
Comment: slough: 4/19 (21%) and 5/20 (25%) |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM CGF (not BNF); n = 20. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Allevyn Adhesive; n = 20. Grouped intervention category: advanced 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 adequate ‐ computer‐generated. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability adequate ‐ no suggestion of problems. Rating: unclear |
| 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 ‐ 6/20 (30%) (2 adverse effects (both due to dressing), 1 death, 2 increased ulcer size, 1 unable to tolerate dressing). Group 2 ‐ 8/20 (40%) (1 participant request, 3 loss to follow‐up, 2 adverse effects (1 related to dressing), 1 death, 1 infection).
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 (selected ulcer) ‐ largest ulcer selected |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, not blinded, some attrition bias
Comments: stratified randomisation (by size); unlikely to be blinded ‐ assessors were clinical investigators who changed dressings. Attrition bias borderline high (because of reasons for missingness) |
