| Methods |
RCT (translation); participants randomised (only 1 wound per person)
Funding: unclear. Setting: hospital inpatients
Duration of follow‐up 8 weeks (also reported at 1, 2, 4, 6 weeks)
Unit of analysis: person (1 ulcer/person) |
| Participants |
141 participants with pressure ulcers. PU Stage: I (23% and 21%), II and III (44% and 38%) and IV (34% and 41%) (PU classification: not stated)
Age: not stated/translated. Duration of ulcer: not stated/translated. Ulcer size: not stated
Wound characteristics at baseline: unclear infection; slough not reported; necrosis not reported; exudate not reported
Comment: number with change in infection status reported, but unclear what sort of change |
| Interventions |
Group 1: topical ‐ sugar plus povidone iodine: sugar 70 g/100 g and povidone iodine 3 g/100 g; ointment applied directly on the wound or applied on a sheet of gauze and then applied on the wound once or twice a day; n = 72. Grouped intervention category: sugar plus povidone iodine
Group 2: other topical ‐ lysozyme ointment (5 g/100 g ointment applied directly on the wound or on a sheet of gauze and then on the wound once or twice a day); n = 69.Grouped intervention category: lysosyme ointment |
| Outcomes |
Primary outcomes: complete healing not reported; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation adequate ‐ random number tables. Allocation concealment adequate ‐ central randomisation with contact details or list held independently. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Other evidence for no blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 27/72 (38%) (withdrew (1 because of adverse effects)). Group 2 ‐ 29/69 (42%) (withdrew (1 because of adverse effects)).
i.e. similar rate missing in both groups; high rate – more 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 |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Comments: unclear selection bias: baseline differences for proportion of Stage 4 ulcers (34% vs 41%); translated as 'not blinded'; attrition bias |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
