| Methods |
RCT; participants randomised (> 1 wound per person, largest selected)
Funding: industry funded ‐ educational grant from Lohmann & Rauscher GmbH (manufacturer of both interventions). Author employee. Setting: hospital inpatients
Duration of follow‐up 3 weeks (also reported at 2 weeks)
Unit of analysis: person (1 ulcer/person) |
| Participants |
10 participants with pressure ulcers. PU Stage: 3 (PU classification: EPUAP)
Age: mean (range): 67.0 (59‐71) years and 63.0 (52‐68) years. Duration of ulcer: at least 4 weeks . Ulcer size: median (range) diameter: 11.4 (5.2‐19.6) cm and 9.3 (4.3‐21.0) cm.
Wound characteristics at baseline: no wounds infected; no wounds sloughy; no wounds necrotic; exudate not reported |
| Interventions |
Group 1: protease‐modulating dressing ‐ Suprasorb C: with Suprasorb P as secondary dressing; n = 5. Grouped intervention category: protease‐modulating dressing
Group 2: foam dressing ‐ Suprasorb P (not in BNF); n = 5. Grouped intervention category: advanced dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 3 weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation adequate ‐ computer‐generated. 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 who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 0. Group 2 ‐ 0 i.e. no missing data (clearly stated) |
| 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) ‐ largest ulcer selected |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
Unclear risk |
Rating: unclear
Reasons: unclear selection bias
Comments: differences at baseline probably unimportant ‐ slightly bigger diameter for the collagen group |
