| Methods |
RCT; ulcers randomised (> 1 wound per person, all followed)
Funding: industry funded ‐ Convatec (manufacturer of hydrocolloid). Setting: hospital inpatients
Duration of follow‐up 12 weeks
Unit of analysis: ulcer |
| Participants |
70 participants with pressure ulcers. PU stage: II (69% and 44%) and III (PU classification: NS).
Age: mean (range): 68 (18‐100) years and 68 (29‐92) years. Duration of ulcer: 55% and 59% < 1 month; 45% and 41% 1‐3 months. Ulcer size: surface area: 2.29 cm² and 2.37 cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: tertiary care centre; "each patient's ulcers were randomised to 1 of 2 treatments" and discussion states ulcers randomised. 94 participants enrolled, but analysis on 70 participants with 97 ulcers |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM CGF (not BNF); n = 33. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline moist; n = 37. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 12 weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
High risk |
Sequence generation unclear ‐ not stated. 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 ‐ Overall 24/94 (26%) (12 died from causes unrelated to PU, 5 discharged from hospital, 5 lost to follow‐up, 1 colonised with MRSA, 1 participant's ulcer progressed to Stage 4. Equivalent number dropped from each group). Group 2 ‐ Overall 24/94 (26%) (12 died from causes unrelated to PU, 5 discharged from hospital, 5 lost to follow‐up, 1 colonised with MRSA, 1 participant's ulcer progressed to Stage 4. Equivalent number dropped from each group)
i.e. overall rate only; low rate ‐ less than control event rate |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear reporting |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation ulcer and unit of analysis ulcer ‐ approx 1.5 ulcer:person ratio = 48/33 and 49/37 |
| 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: selection bias (baseline imbalance), available case only, baseline imbalance
Comments: results and number of ulcers not reported for those that dropped out of the study, so available case analysis only. Significantly more grade III ulcers for the saline gauze dressing vs hydrocolloid (56% vs 31%). Ulcers randomised and analysed so no unit of analysis issues |
