| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: industry funded ‐ CV Laboratories Ltd (foam manufacturer) and Calgon Vestal Laboratories (HC manufacturer). Setting: hospital inpatients
Duration of follow‐up 6 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
29 participants with pressure ulcers. PU Stage: II and III (involving loss of skin) proportions not stated (PU classification: not stated)
Age: median (range): 74 (40‐95) years and 73 (40‐88) years. Duration of ulcer: median (range): 5.5 (2‐365) days and 7 (2‐14) days. Ulcer size: median (range): 2.4 (0.1‐25.8) and 1.4 (0.5‐14.3) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; no wounds necrotic; exudate moderate levels |
| Interventions |
Group 1: hydrocolloid dressing ‐ Granuflex: Granuflex E; additional support therapy for immobile participants; n = 16. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Spyrosorb (not in BNF) (additional support therapy for immobile participants); n = 13). 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 unclear ‐ “randomised”. 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 |
High risk |
Not blinded ('open label') and no evidence that outcome assessor was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 4/16 (25%) (3 wound deterioration, 1 wound/dressing‐related problems). Group 2 ‐ 3/13 (23%) (1 wound deterioration, 1 wound/dressing‐related problems, 1 discharged from hospital)
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| 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: high
Reasons: unclear selection bias, not blinded, baseline differences
Comments: wound area showed no significant difference, but median 2.4 versus 1.4; Grade II assumed to be acceptable (loss of skin tissue) |
