| Methods |
RCT; participants randomised (unclear if > 1 wound per person)
Funding: not stated. Setting: care home
Duration of follow‐up 8 weeks
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
38 participants with pressure ulcers. PU Stage: 2 (PU classification: EPUAP)
Age: mean age 83.8 years, range 74.9‐95.1 and 82.5 years, range 66.4‐91.9 . Duration of ulcer: at least 4 weeks; NICE guideline: mean (range) 8.3 (1‐24) weeks and 13.0 (1‐52) weeks. Ulcer size: not reported (table 2 missing); NICE guideline: mean 4.9 (0.7‐25.3) cm² and 5.4 (0.2‐26.0)
Wound characteristics at baseline: no wounds infected; some wounds sloughy; no wounds necrotic; exudate not reported
Comment: red‐yellow wounds in the red‐yellow‐black system (no necrosis, but some slough) |
| Interventions |
Group 1: soft polymer dressing ‐ Mepilex Border; n = 18. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Tielle; 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 ‐ envelopes not said to be opaque. Baseline comparability unclear ‐ no information. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded to interventions – clear description |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 1/18 ? (6%) (unclear if other withdrawals) (1 died during the study (so missing), 1 had hip fracture). Group 2 ‐ 1/20? (5%) (unclear about withdrawals) (1 died (but unclear when and not listed by authors as missing); 1 developed symptoms of heart disorder).
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 |
Low risk |
Unit of randomisation person and unit of analysis person (unclear if > 1 ulcer analysed) ‐ implies 1 per person |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Comments: unclear selection bias ‐ allocation concealment: envelopes not said to be opaque; also says block size unknown to investigators and predetermined list; not blinded; unclear re missing data and appropriate tables not available |
