| Methods |
RCT; participants randomised (> 1 wound per person, other selection of wound)
Funding: industry funded ‐ 3M grant (manufacturers of Tegaderm). Setting: care home and community
Duration of follow‐up 8 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
72 participants with pressure ulcers. PU Stage: II (59.5% and 65%; P = 0.59), and shallow III (PU classification: not stated)
Age: mean 72.7 (SD 18.61) years and 78.3 (SD 14.70) years. Duration of ulcer: median (range): 32.0 days (2‐635) and 21.0 days (1‐291); P = 0.169. Ulcer size: mean (SD): 2.5 (4.86) and 1.5 (1.69) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; some wounds necrotic; exudate low‐moderate levels
Comment: < 25% necrotic |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM CGF; n = 37. Grouped intervention category: advanced dressing
Group 2: vapour‐permeable dressing ‐ Tegaderm Absorbent Clear; n = 35). 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 ‐ no information on allocation concealment. Baseline comparability adequate ‐ no suggestion of problems. 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 ‐ none. Group 2 ‐ none
i.e. no missing data (no details) |
| 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) ‐ if > 1, authors selected highest grade PU then largest ulcer |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, not blinded |
