| Methods |
RCT; participants randomised (> 1 wound per person, largest selected)
Funding: industry funded ‐ funded by Smith & Nephew (manufacturers of PU foam). Setting: care home and hospital and community
Duration of follow‐up 4 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
36 participants with pressure ulcers. PU Stage: 2 (PU classification: NPUAP)
Age: median 74.0 years and 71.5 years; mean (SD): 72.5 (14.3) years and 73.3 (12.4) years. Duration of ulcer: median 3.5 weeks and 2.0 weeks. Ulcer size: median 1.8 cm² and 1.4 cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate low‐moderate levels
Comment: multicentre (2 hospital inpatient wards, 1 hospital outpatients, 1 community, 1 care home) |
| Interventions |
Group 1: foam dressing ‐ Allevyn Thin: no secondary dressing; n = 20. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline soaked (secondary dressing as required); n = 16. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 4 weeks; time to complete healing reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation unclear ‐ other. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear ‐ vague |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 6/20 (30%) (3 died, 1 developed wound infection, 1 developed an abscess unrelated to the study wound, 1 ineligible for other reasons). Group 2 ‐ 3/16 (19%) (2 died, 1 asked to be discharged)
i.e. differential missing data rates; high differential rate – likely to change effect estimate |
| 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) ‐ largest ulcer selected |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, attrition bias
Comments: "randomisation schedule"; may be a difference in duration of wound at baseline (3.5 and 2.0 weeks) |
