| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: industry funded ‐ CV Laboratories Ltd (foam manufacturer) and Calgon Vestal Laboratories (HC manufacturer). Setting: community
Duration of follow‐up 6 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
40 participants with pressure ulcers. PU Stage: II and III (Stages I, IV, V excluded); proportions not stated (PU classification: not stated)
Age: median (range): 73 (46‐93) years and 71 (40‐100) years. Duration of ulcer: median (range): 21 (5‐252) days and 56 (3‐365) days; P < 0.08. Ulcer size: median (range): 0.74 (0.16‐8.19) cm² and 0.67 (0.03‐9.7) cm²; mean 1.51 (SD1.86) cm² and 1.47 (SD 2.26) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; no wounds necrotic; exudate unclear
Comment: exuding wounds but level not stated. Inclusion criteria: shallow/moist pressure sore involving loss of skin tissue |
| Interventions |
Group 1: hydrocolloid dressing ‐ Granuflex: concurrent standard pressure‐relieving devices and cushions in community as appropriate; n = 20. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Spyrosorb (not in BNF) (necessary by the treating health professional); n = 20). Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 6 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 of unclear importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded ('open label') and no evidence that outcome assessor was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 10/20 (50%) withdrawn (2 wound deteriorated, 2 overgranulation, 2 discomfort, 4 unrelated to wound (2 died, 2 had respite care)). Group 2 ‐ 2/20 (10%) (2 for reasons unrelated to wound (1 died, 1 admitted to hospital))
i.e. differential missing data rates; high differential rate – likely to change effect estimate |
| Selective reporting (reporting bias) |
High risk |
Inadequate – outcome included in methods section but not results |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis person (1 ulcer/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: very high
Reasons: unclear selection bias, not blinded, attrition bias
Comments: some difference in duration of ulcers; time‐to‐event data reported only as not significant; Grade II assumed to be acceptable (loss of skin tissue) |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
