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

Imamura 1989.

Methods Country where data collected: Japan
Parallel group RCT
Unit of randomisation: participant
Unit of analysis: participant
Duration: 8 weeks (8 weeks follow‐up duration)
Participants Inclusion criteria: participants with pressure ulcers stages 1‐4 treated in hospital
Exclusion criteria: not reported
Participants: N = 141 (randomised); 139 analysed of whom 109 had stage 2 or above pressure ulcers
Mean age: Not reported
Number of males: 37/71 vs 30/68
Ulcer stage: stage 1 16 vs 14; stage 2 or 3 31 vs 26; stage 4 24 vs 28
Ulcer location: sacrum 51 vs 45; ischium 6 vs 6; back 6 vs 4; greater trochanter 4 vs 4; ilium 1 vs 6; other 3 vs 4.
Ulcer size (cm²): 25.48 (SE 4.34) vs 29.29 (SE 4.65)
Interventions Intervention arm 1: KT‐136 (sugar (70g/100g) and povidone iodine (3g/100g)) ointment applied directly on to the wound or to the gauze sheet applied to the wound. Application once or twice a day.
Intervention arm 2: lysozyme ointment (5g/100g) applied directly on to the wound or to the gauze sheet applied to the wound. Application once or twice a day.
Cointerventions: none reported
Outcomes Primary outcome: proportion of wounds completely healed
Primary outcome: adverse events and serious adverse events
Secondary outcome: wound area reduction
Secondary outcome: infection
Notes Trial published entirely in Japanese; assessment for inclusion, data extraction and risk of bias assessment all conducted by one review author
Funding: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table used
Allocation concealment (selection bias) Low risk Central telephone allocation
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding was used
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No reasons were provided for missing data
Selective reporting (reporting bias) Unclear risk This was unclear due to poor reporting
Other bias Unclear risk Multiple sources of uncertainty