| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: not stated. Setting: community
Duration of follow‐up 6 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
99 participants stratified by wound. PU Stage: II and III (61% and 54% grade II) (PU classification: Stirling)
Age: 78.6 (SD 14.3) years, 80.1 (SD 10.2) years. Duration of ulcer: 9 and 8 at < 1 month; 18 and 21 at 1‐3 months, 21 and 20 at > 3 months. Ulcer size: not stated
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: text says "for each wound type, patients were allocated to 2 treatment groups" => implied stratification |
| Interventions |
Group 1: hydrocolloid dressing ‐ Granuflex: cleansed using 0.9% saline as necessary; n = 49. Grouped intervention category: advanced dressing
Group 2: foam dressing ‐ Tielle (cleansed using 0.9% saline as necessary); n = 50. 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 ‐ "sealed envelopes". 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 ‐ 1/49 (2%) and some may have died (reason not stated; overall 5 participants died). Group 2 ‐ 2/50 (4%) and some may have died (reason not stated; overall 5 participants died)
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| 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) |
| 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
Comments: difference in proportion of grade II ulcers (61% and 54%) |
