| Methods |
RCT; nursing module (cluster)s randomised (> 1 wound per person, all followed)
Funding: non‐industry funding ‐ supported by Rush‐Presbyterian‐St Lukes Medical Center and Chicago Community Trust. Setting: hospital inpatients
Duration of follow‐up 1.5 (12 days) weeks
Unit of analysis: ulcer |
| Participants |
15 participants with pressure ulcers. PU Stage: I (22% and 50%) and II, results separately for II. Inclusion criteria state all should have break in skin (PU classification: Enis and Sarmiento)
Age: overall mean (SD): 69 (6), range 52‐93 years. Duration of ulcer: not stated. Ulcer size: mean 3.5 (SD 1.2), range 1.7‐5.0 cm²; mean 7.9 (SD 7.3), range 1.2‐22.7cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: nursing modules on 4 participating units were randomised (no info on cluster size) |
| Interventions |
Group 1: foam dressing ‐ self adhesive PU dressing; n = 7 (5 grade II). Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ other (normal saline dressing); n = 8 (5 grade II). Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 1.5 (12 days) weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
High risk |
Sequence generation unclear ‐ other. 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 |
Low risk |
Blinded to interventions (clear description) |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 1/16 dropped from analysis but group unclear (1 unanticipated transfer to nursing home). Group 2 ‐ 1/16 dropped from analysis but group unclear (1 unanticipated transfer to nursing home).
i.e. overall rate only; high rate ‐ comparable with control event rate |
| Selective reporting (reporting bias) |
Low risk |
Inadequate – reported incompletely (e.g. P value > 0.05) |
| Other bias
unit of analysis |
High risk |
Unit of randomisation nursing module (cluster) and unit of analysis ulcer ‐ 4/15 (27%) participants had 2 ulcers each (2 participants had different treatments for their 2 ulcers); < 1.3 ulcer:person ratio = 9/7 and 10/8 |
| Other bias
additional |
Unclear risk |
Results not adjusted for clustering. Unclear if grades I and II are subgroups in this classification |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Reasons: inadequate selection bias (baseline characteristics), attrition bias, unit of analysis issues
Comments: results not adjusted for clustering. Unclear if grades I and II are subgroups in this classification. Differences at baseline in proportion grade II (7/9 and 5/10 ulcers) and size of PU (mean 3.5 and 7.9 cm²) |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
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