| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: non‐industry funding ‐ declaration of interest: none. Setting: hospital inpatients
Duration of follow‐up 8 weeks
Unit of analysis: ulcer |
| Participants |
34 participants with pressure ulcers. PU Stage: II (non‐blanching erythema and superficial damage ‐ may be closer to NPUAP I; 33% and 30%) and III (PU classification: Torrance)
Age: mean (SD): 58.7 (14.1) years and 58.5 (16.9) years. Range overall: 24–88 years. Duration of ulcer: mean (SD): 2.45 (1.60) weeks and 2.46 (0.24) weeks. Ulcer size: mean (SD): 8.28 (13.90) cm² and 11.04 (11.65) cm². Range: 0.41‐98.78 and 0.68‐51.05 cm²
Wound characteristics at baseline: some wounds infected; slough not reported; no wounds necrotic; exudate not reported
Comment: participants were people with advanced cancer in palliative care department; 38/34 ulcers per person; 9/17 (53%) and 10/17 (59%) participants had infected wounds |
| Interventions |
Group 1: hydrogel dressing ‐ Aquagel (not in BNF); n = 17. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Lyofoam; n = 17. 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 unclear ‐ baseline difference but unclear of importance. 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 ‐ 3/17 (18%) (3 died ). Group 2 ‐ 2/17 (12%) (2 died)
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
High risk |
Unit of randomisation person and unit of analysis ulcer ‐ ulcer:person ratio = 20/17 (1.2) and 18/17 (1.1) |
| 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, unclear subgroup ‐ grade II Torrance may be closer to NPUAP stage I, could be subgroup issue. Slightly larger wounds for foam. Slight unit of analysis issue |
