| Methods |
RCT; participants randomised (> 1 wound per person, ulcer chosen at random)
Funding: non‐industry funding ‐ explicit statement that not industry funded. Supported by The Family Health Foundation of America. Setting: care home
Duration of follow‐up 26 weeks (6 months) protocol
Unit of analysis: person (1 ulcer/person) |
| Participants |
39 participants with pressure ulcers. PU Stage: II (100% and 90%) and III (Shea ‐ must have a break in the skin for inclusion) (PU classification: Shea)
Age: mean (SD): 77.3 (16.9) years and 83.5 (10.6) years. Duration of ulcer: not stated. Ulcer size: median (range): 0.66 (0.12‐13.4) cm² and 0.38 (0.04‐24.6) cm²
Wound characteristics at baseline: infection not reported; slough not reported; some wounds necrotic; exudate mixed levels
Comment: necrotic tissue: 2/18 (11%) and 7/21 (33%) but debridement used before and throughout, so unclear whether successful. Exudate: level not stated, but 9/18 (50%) and 7/21 (33%) had exudate at baseline. Exudate and necrosis were independent predictors of healing |
| Interventions |
Group 1: hydrocolloid dressing ‐ DuoDERM; n = 18. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline wet‐to‐moist; n = 21. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 26 weeks (6 months); time to complete healing reported (Kaplan Meier plot included) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation unclear ‐ “randomised”. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability adequate ‐ no suggestion of problems. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded to interventions – clear description |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 2/18 (11%) (1 hospitalised, 1 withdrew consent). Group 2 ‐ 3/21 (14%) (3 died)
i.e. similar rate missing in both groups; low rate – unlikely to alter the effect estimate |
| 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) ‐ ulcer chosen at random (by coin toss) |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, not blinded |
