| Methods |
RCT; ulcers randomised (> 1 wound per person, all followed)
Funding: industry funded ‐ 3M Company. Setting: hospital and care home
Duration of follow‐up 8 weeks
Unit of analysis: ulcer |
| Participants |
87 participants with pressure ulcers. PU Stage: II (60% and 76%) and III (% of available cases) (PU classification: Shea)
Age: not stated. Duration of ulcer: not stated. Ulcer size: mean (SD): 8.3 (9.9), range 0.4‐43.9 cm² and 7.6 (8.6), range 0.2‐35.2 cm²
Wound characteristics at baseline: some wounds infected; some wounds sloughy; some wounds necrotic; exudate not reported
Comment: 32/42 (76%) and 32/45 (71%) had infected wounds at baseline. Initially 81% and 62% wounds necrotic but treated before randomised treatments given |
| Interventions |
Group 1: hydrocolloid dressing ‐ Tegasorb (not in BNF): dressing scheduled to be changed every 7 days; if there was necrotic tissue it was debrided; n = 100 ulcers randomised (total), number of participants not stated, but available cases 87 total. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline wet‐to‐damp (dressing scheduled to be changed every 8 h; if there was necrotic tissue it was debrided); n = 100 ulcers randomised (total), number of participants not stated, but available cases 87 total. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8 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 inadequate ‐ alternation. 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 13/100 (13%) ulcers excluded from the analysis (intercurrent medical events (n = 11) and 2 had protocol violations). Group 2 ‐ overall 13/100 (13%) ulcers excluded from the analysis (intercurrent medical events (n = 11) and 2 had protocol violations)
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 ‐ 22/87 (25%) participants had 2 ulcers |
| Other bias
additional |
Unclear risk |
25% had 2 ulcers ‐ not treated as paired data |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high/very high
Reasons: high selection bias; unclear blinding, some unit of analysis issues
Comments: some baseline differences in grade of ulcer 60% and 76% grade II and HC size was larger, with more necrotic tissue; if participants had 2 ulcers, then alternation; blinding not stated, overall 13/100 missing data; number of ulcers per group not stated, so available case used; 25% had 2 ulcers ‐ not treated as paired data |
