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. 2016 Apr 4;2016(4):CD011586. doi: 10.1002/14651858.CD011586.pub2

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)
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
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))
Outcomes Primary outcome: adverse events
Secondary outcome: wound area reduction
Secondary outcome: infection (microbiological data only)
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
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