Toba 1997.
Methods | Country where data collected: Japan Parallel group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 14 weeks (duration), 2 years (follow‐up) |
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Participants | Inclusion criteria: detected MRSA from ulcers in previous month Excusion criteria: not reported N: 19 participants N males: 0/19 Mean age (years): 83.5 ± 3.0 years old Participants were hospital inpatients with cerebrovascular disorder, without diabetes, malignant tumours and liver dysfunctions |
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Interventions | Intervention arm 1: GVcAMP (base: polyethylene glycol (SOLBASE), 0.1% Gentian Violet (Piokutanin): Dibutyryl cAMP (Actsin) = 1:1) Intervention arm 2: IS (Iodine Sugar(U‐PASTA)) |
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Outcomes | Primary outcome: adverse events Secondary outcome: wound area reduction Secondary outcome: infection (microbiological data only) |
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Notes | Trial published in Japanese; data extraction and risk of bias assessment conducted by single translator. Assessed as meeting inclusion criteria for pressure ulcers (and stages) by translator. Funding: NR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by using a table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Using a table of random numbers which was unclear whether open or not |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts |
Selective reporting (reporting bias) | Unclear risk | The protocol is not available, insufficient information to permit judgement |
Other bias | Unclear risk | Some sources of uncertainty |