| Methods |
RCT; participants randomised (> 1 wound per person, other selection of wound)
Funding: industry funded ‐ Urgo (manufacturers of intervention 2). Setting: hospital inpatients
Duration of follow‐up 8 weeks
Unit of analysis: person (selected ulcer) |
| Participants |
110 participants with pressure ulcers. PU Stage: III and IV; stage III proportions = group 1: 82.7% and group 2: 71.4% (PU classification: Yarkony)
Age: 82.2 (SD 7.9) years and 84.8 (SD 7.1) years . Duration of ulcer: 7.7 weeks and 7.2 weeks. Ulcer size: mean 12.6 (SD 8.0) cm² and 14.7 (SD 10.4) cm² (NS)
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM Extra Thin: note different HC; hydrocolloid paste for deep ulcers. Prior treatment with mainly HC; n = 53. Grouped intervention category: advanced dressing
Group 2: sequential dressing ‐ hydrocolloid‐alginate (Urgosorb (4 weeks) then Algoplaque (4 weeks); hydrocolloid paste for deep ulcers in first 4 weeks only. Prior treatment mainly HC); n = 57. 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 unclear ‐ “randomised”. Allocation concealment unclear ‐ other. 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 |
High risk |
Missing data: Group 1 ‐ all analysed, though 16/53 (30%) did not complete treatment (8 died and 8 withdrew (2 transfer to another unit, 3 local infection, 3 PU impairment)). Group 2 ‐ all analysed, though 17/57 (30%) did not complete treatment (11 died and 6 withdrew (1 transfer to another unit, 1 worsening health status, 1 local infection, 3 PU impairment))
i.e. all analysed but non‐completers ‐ similar rate in each group; high rate – more than 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) ‐ one ulcer 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: high
Comments: unclear selection bias (block randomised), different hydrocolloids and pastes used; unclear who assessed healing ‐ nurses not blinded, assessor of wound area was blinded; baseline differences: diabetes, hypertension significantly higher for sequential; proportion of grade IV ulcers higher in sequential |
