| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: mixed industry and non‐industry ‐ Biocore Medical Technologies supplied the collagen + grant from Retirement Research Foundation. Setting: care home
Duration of follow‐up 8 weeks (also reported at 1 and 4 weeks)
Unit of analysis: person (1 ulcer/person) |
| Participants |
65 participants with pressure ulcers. PU Stage: 2 (77% and 83%) and 3 (PU classification: NPUAP)
Age: 80.6 (SD 12.2) years and 82.0 (SD 9.9) years. Duration of ulcer: median (IQR): 6.5 (2.0, 12.0) weeks and 3.0 (1.6, 8.0) weeks (not statistically significant). Ulcer size: median (IQR) 1.74 (0.5, 4.36) and 1.21 (0.63, 3.38); not statistically significant
Wound characteristics at baseline: infection not reported; no wounds sloughy; no wounds necrotic; exudate not reported
Comment: wounds with eschar (not slough) or necrosis excluded (but re‐included after debridement) |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM: twice‐weekly. Standard nursing care. No ancillary non‐protocol treatments; n = 30. Grouped intervention category: advanced dressing
Group 2: protease‐modulating dressing (cleansed with saline then sprinkled with collagen particles in thin continuous layer; covered with dry gauze. Standard nursing care. No ancillary non‐protocol treatments); n = 35. Grouped intervention category: protease‐modulating dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8 weeks; time to complete healing reported (Kaplan Meier plot included) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Low risk |
Sequence generation adequate ‐ computer‐generated. Allocation concealment adequate ‐ central randomisation with contact details or list held independently. Baseline comparability adequate ‐ no suggestion of problems. Rating: low |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded to interventions (clear description) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 5/30 (17%) (1 withdrew consent, 3 died, 2 hospitalised). Group 2 ‐ 6/35 (17%) (2 died, 1 hospitalised, 2loss to follow‐up).
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| 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) |
| Other bias
additional |
Low risk |
Adequate ‐ well‐conducted study |
| ALL‐DOMAIN RISK OF BIAS |
Low risk |
Rating: low
Comments: some differences at baseline (size and duration) but not statistically significant |
