| Methods |
RCT; unit of randomisation unclear (> 1 wound per person, all followed)
Funding: not stated. Setting: hospital and care home
Duration of follow‐up 8.5 (60 days) weeks
Unit of analysis: ulcer |
| Participants |
90 participants with pressure ulcers. PU Stage: I and II (54% and 56%) (results separate); stage I is ulceration or skin breakdown limited to superficial epidermal and dermal layer ‐ probably corresponds to grade II? (PU classification: Enis and Sarmiento).
Age: overall mean: 75 years (range 30‐98); mean in acute care 69 years, in care homes 83 years. Duration of ulcer: not stated. Ulcer size: hydrogel: mean 11.0 (range 0.2‐100) cm²; hydrocolloid: mean 9.2 (0.4‐63.75) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: it says wounds randomised, but also says people with multiple wounds had same treatments; 67/49 (1.4) and 62/41 (1.5) wounds per person |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM; n = 49 overall. Grouped intervention category: advanced dressing
Group 2: hydrogel dressing ‐ Biofilm (not in BNF); n = 41 overall. Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8.5 (60 days) 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 unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear ‐ no information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 4/67 (6%) excluded from the authors' analysis (3 wounds' size increased by more than 10% per day and 1 decreased by more than 25% per day). Group 2 ‐ 2/62 (3%) excluded from the authors' analysis (1 wound's size increased by more than 10% per day and 1 decreased by more than 25% per day).
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| Selective reporting (reporting bias) |
High risk |
Inadequate – reported incompletely |
| Other bias
unit of analysis |
High risk |
Unit of randomisation unclear and unit of analysis ulcer ‐ Overall ulcer:person ratio = 67/49 and 62/41 (1.52) |
| Other bias
additional |
Unclear risk |
Extraction from a graph |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high/very high
Reasons: unclear selection bias, unit of analysis issues; extraction from a graph
Comments: baseline difference: 11.0 versus 9.2 cm² mean wound area; number of ulcers reported for grade II only on graph. May be best to report overall (see definition of stage I). Unit of analysis issues; 6/90 participants excluded as outliers |
