Barrois 1993.
Methods | Multicentre parallel RCT (countries not reported) Duration: 56 days Unit of randomisation: participant Unit of analysis: participant |
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Participants | Inclusion criteria: people presenting with open necrotic pressure ulcers Participants: 76 people with ulcers; Ulcer size (cm²): 15 (reported comparable between groups) Age, gender, ulcer location, ulcer stage not reported ("open necrotic pressure sore" interpreted by review authors as stage II or higher). |
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Interventions | Intervention arm 1: gauze (Tulle) with povidone iodine Intervention arm 2: hydrocolloid dressing (Granuflex) Co‐interventions: cleansing with saline and debridement with forceps if necessary in both groups. |
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Outcomes | Primary outcome: proportion of wounds completely healed Primary outcome: adverse events Secondary outcome: resource use (dressings per week) |
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Notes | Reported in abstract only; authors not contacted due to date of publication Funding: NR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Reported in abstract only |
Allocation concealment (selection bias) | Unclear risk | Reported in abstract only |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Reported in abstract only |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Thirty‐eight patients received Granuflex and 38 received a Tulle dressing impregnated with povidone‐iodine antiseptic ointment......Two patients receiving Granuflex and five patients receiving the control dressing dropped out of the trial due to a deterioration in the pressure sore" Comment: 7 of 72 patients were not included in the analyses; reasons specified. |
Selective reporting (reporting bias) | Unclear risk | Reported in abstract only |
Other bias | Unclear risk | Reported in abstract only |