Chuangsuwanich 2011.
| Methods | Country where data collected: Thailand Parallel group RCT Unit of randomisation: participant Unit of analysis: participant Duration: 8 weeks |
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| Participants | Inclusion criteria: people with stage III/IV pressure ulcers. Exclusion criteria: not reported Participants: 40 hospital inpatients and outpatients Mean age (years): 62.6 vs 69.1 Number of Males: 8/20 vs 9/20 Ulcer size (cm²): 12.17 vs 22.82 Ulcer location: sacrum 16/20 vs 14/20, trochanter 1/20 vs 5/20, ischium 3/20 vs 1/20 Ulcer stages: distribution not reported |
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| Interventions | Intervention arm 1: silver mesh dressing changed every 3 days. Intervention arm 2: silver sulfadiazine cream changed twice daily. Co‐interventions: wound cleansing at every dressing change and cotton gauze outer dressing in both groups. Debridement as required. |
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| Outcomes | Primary outcome: adverse events Secondary outcome: wound area reduction Secondary outcome: infection (qualitative bacteriological data only) |
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| Notes | Funding NR | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “The ulcers graded III‐IV were divided randomly by computer into two 20 patient‐groups.” Comment: Computer generated randomisation sequence |
| Allocation concealment (selection bias) | Unclear risk | Quote: “The ulcers graded III‐IV were divided randomly by computer into two 20 patient‐groups.” Comment: Although appropriate generation of sequence no information on concealment of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: “The ulcer healing was assessed by using the Pressure Ulcer Scale for Healing (PUSH 3.0) every two weeks also. PUSH tool was used for evaluation of the condition of the wounds.” Comment: No indication if assessment was blinded to allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “Forty patients enrolled to the present study. Twenty patients in each group finished the eight‐week study.” Comment: Outcome data reported for all randomised patients |
| Selective reporting (reporting bias) | Unclear risk | Comment: No direct quote but primary/secondary outcomes not stated a priori |
| Other bias | Unclear risk | Quote: “Wounds were debrided as necessary.” Comment: not clear how often this happened or how it differed between groups |