| Methods |
RCT; participants randomised (> 1 wound per person, unclear how assessed)
Funding: unclear ‐ authors at wound healing research unit. Setting: hospital and community
Duration of follow‐up 12 weeks (also reported at 1, 2, 6 weeks)
Unit of analysis: person (unclear if > 1 ulcer analysed) |
| Participants |
50 participants with pressure ulcers. PU Stage: II (non‐blanching erythema +/‐ superficial damage) and III (PU classification: Torrance)
Age: 68% over 75 years. Duration of ulcer: ascertained but not reported. Not available for 28%. Ulcer size: 16 and 19 ≤ 1 cm², 3 and 3 > 1 cm² and ≤ 2.5 cm²; 7 and 2 > 2.5 cm²
Wound characteristics at baseline: no wounds infected; not reported; no wounds necrotic; exudate not reported
Comment: number ulcers/person not stated, but some had > 1 ulcer |
| Interventions |
Group 1: foam dressing ‐ Lyofoam; n = 26. Grouped intervention category: advanced dressing
Group 2: basic wound contact dressing ‐ N‐A Dressing; n = 24). Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 12 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 adequate ‐ independent 3rd party allocates and retains schedule. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear ‐ vague |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 7/26 (27%) (2 died, 5 withdrew; 2 reasons NS, 2 improved, 1 deteriorated). Group 2 ‐ 9/24 (38%) (2 died, 7 withdrew, 2 reason NS, 1 improved, 4 deteriorated)
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 (unclear if > 1 ulcer analysed) ‐ stated that protocol allowed > 1 per wound person, but no evidence that this happened |
| 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
Comments: trial co‐ordinator was outcome assessor, unclear if blinded; imbalance at baseline ‐ not clear if problem. More large ulcers for intervention 1 |
