| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: industry funded ‐ study authors have now founded a company to manufacturer intervention 1. Setting: hospital inpatients
Duration of follow‐up 26 weeks (6 months)
Unit of analysis: results for both people and ulcers |
| Participants |
37 participants with pressure ulcers. PU Stage: 2 (39% and 45%), 3 (50% and 45%) and 4 (11% and 9%) (PU classification: EPUAP)
Age: per protocol: mean (SD) 80 (10) years and 74 (8) years; range 58‐98 years and 60‐88 years. Duration of ulcer: not stated. Ulcer size: width mean(SD): 3.2 (2.4) cm and 4.2 (2.8) cm
Wound characteristics at baseline: some wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: 27/21 and 18/16 ulcers per person (18 (86%) and 14 (88%) participants had only 1 ulcer); number of ulcers infected not stated |
| Interventions |
Group 1: resin salve ‐ resin salve: Norway spruce salve mixed with butter between gauze; n = 21. Grouped intervention category: antimicrobial
Group 2: hydrocolloid or hydrocolloid silver dressing ‐ Aquacel + Aquacel Ag (Aquacel Ag if infected wounds (NS proportion)); n = 16). Grouped intervention category: advanced ‐ antimicrobial |
| Outcomes |
Primary outcomes: proportion completely healed at 26 (6 months) weeks; 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 ‐ other. Allocation concealment unclear ‐ other. 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 |
High risk |
Missing data: Group 1 ‐ 8/21 (38%) (3 deaths, 2 admissions to operative treatment, 1 allergic skin reaction, 1 misdiagnosis, 1 participant‐based refusal without any specific cause). Group 2 ‐ 7/16 (44%) (4 deaths, 2 participant‐based refusal without any specific cause, 1 participant‐based refusal because of randomisation to control group)
i.e. similar rate missing in both groups; high rate – more than control event rate |
| Selective reporting (reporting bias) |
High risk |
Inadequate ‐ other. Time to event outcome excluded dropouts |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis results for both people and ulcers ‐ 3/21 (14%) and 2/16 (12.5%) participants had > 1 ulcer; study analysis seemed to require that all ulcers in a person should heal; ulcers:person ratio = 27/21 (1.3) and 18/16 (1.1) |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, attrition bias, time to event outcome excluded drop outs, so risk of outcome reporting bias for that outcome only
Comments: randomisation in permuted blocks of 4. Randomisation list in closed envelopes. Independent physicians in each hospital assessed wound ‐ this is probably enough for blinding. Time to event outcome excluded dropouts |
