| Methods |
RCT (letter to journal); participants randomised (unclear if > 1 wound per person)
Funding: industry funded ‐ Acme/Chaston division, National Patent Development Corp (manufacturer poly HEMA). Setting: care home
Duration of follow‐up 8 weeks
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
43 participants with pressure ulcers. PU Stage: II and III (description available); stratified then randomised; proportions not stated (PU classification: not stated)
Age: median 86 years and 82 years. Duration of ulcer: not stated, but comparable. Ulcer size: median 2.5 cm² and 1.9 cm² (P = 0.09)
Wound characteristics at baseline: infection not reported; slough not reported; some wounds necrotic; exudate not reported
Comment: if necrosis, wounds were debrided first |
| Interventions |
Group 1: hydrogel dressing ‐ poly HEMA: Hydron dressing; n = 27. Grouped intervention category: advanced dressing
Group 2: hydrocolloid dressing ‐ DuoDERM; n = 16. Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8 weeks; time to complete healing reported (Kaplan Meier plot included) |
| 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 to interventions – clear description |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 2/27 (7%) (both died). Group 2 ‐ 3/16 (19%) (1 died, 2 did not complete treatment (1 poor response, 1 adverse event))
i.e. differential missing data rates; low differential rate – unlikely to change effect estimate |
| 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 (unclear if > 1 ulcer analysed) ‐ one ulcer implied (e.g. "52% of group 1 had complete healing of the study 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
Comments: unblinded research nurse who had no clinical responsibilities |
