| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: not stated. Setting: hospital inpatients
Duration of follow‐up 5 weeks
Unit of analysis: ulcer |
| Participants |
27 participants with pressure ulcers. PU Stage: II and III (96% III in both groups) (PU classification: AHCRQ)
Age: mean (SD): 65.80 (6.30) years and 66.56 (5.53) years. Duration of ulcer: not stated. Ulcer size: not stated
Wound characteristics at baseline: unclear infection; slough not reported; necrosis not reported; exudate not reported
Comment: staging used AHRQ guidelines (probably NPUAP). Infection implied (control said to be a treatment for infected ulcers). 50+ ulcers (1 participant excluded and not stated no. of ulcers), 27 participants; all ulcers assessed |
| Interventions |
Group 1: honey ‐ unprocessed gauze impregnated (dressing): semi‐permeable adhesive secondary dressing; n = 15. Grouped intervention category: antimicrobial
Group 2: combination dressing ‐ ethoxy‐diaminoacridine plus nitrofurazone dressings; n = 12. Grouped intervention category: antimicrobial |
| Outcomes |
Primary outcomes: proportion completely healed at 5 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 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 |
High risk |
Missing data: Group 1 ‐ 0. Group 2 ‐ 1/12 (8%) (1 died)
i.e. similar rate missing in both groups; high rate ‐ comparable with control event rate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ reported incompletely as ‘significant’ or P value < 0.05 |
| Other bias
unit of analysis |
High risk |
Unit of randomisation person and unit of analysis ulcer ‐ ulcer:person ratio: 25/15 (1.7) and 26/12 (2.2) |
| Other bias
additional |
Unclear risk |
Only available case analysis reported |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Reasons: unclear selection bias, not blinded, attrition bias, unit of analysis issues |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
