| Methods |
RCT; wards randomised (> 1 wound per person, all followed)
Funding: not stated. Setting: hospital inpatients
Duration of follow‐up approx 11 (assumed from mean + SD) weeks
Unit of analysis: ulcer |
| Participants |
52 participants with pressure ulcers. PU Stage: II (87% and 79%) and III (with acceptable definition) (PU classification: not stated)
Age: mean (SD): 72.0 (12.8) years and 68.4 (13.5) years; proportion ≥ 65 years: 75% and 56%. Duration of ulcer: not stated. Ulcer size: not stated
Wound characteristics at baseline: some wounds infected; slough not reported; some wounds necrotic; exudate not reported
Comment: infection at baseline: 9% and 23%; proportion with necrotic wounds not stated |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM; n = 27. Grouped intervention category: advanced dressing
Group 2: ineligible intervention ‐ whirlpool + chloramine dressing (gauze dampened with Dakin's solution + whirlpool hydrotherapy 3 times/week); n = 25. Grouped intervention category: ineligible ‐ whirlpool |
| Outcomes |
Primary outcomes: proportion completely healed at approx 11 (assumed from mean + SD) weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
High risk |
Sequence generation unclear ‐ “randomised”. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability inadequate ‐ baseline characteristics different between arms. Rating: high |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ none. Group 2 ‐ none
i.e. no missing data (clearly stated) |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
High risk |
Unit of randomisation ward and unit of analysis ulcer ‐ each ward assigned one or other treatment regimen |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Reasons: selection bias (large baseline differences); unit of analysis issues ‐ ward randomised, ulcer analysed; unclear blinding
Comments: baseline differences for: proportion of ulcers in over 65 age group (greater for hydrocolloid), proportion of grade II ulcers (87% and 79%), proportion infected ulcers (9% and 23%) |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
