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) |
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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) |
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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 |
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Outcomes | Primary outcome: proportion of wounds completely healed Primary outcome: adverse events and serious adverse events Secondary outcome: wound area reduction Secondary outcome: infection |
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Notes | Trial published entirely in Japanese; assessment for inclusion, data extraction and risk of bias assessment all conducted by one review author Funding: NR |
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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 |