Mazzone 1993.
Methods | Two‐arm RCT (not clear if single or multi‐centred) comparing a foam dressing (PolyMem, Ferris) with wet‐to‐dry saline gauze dressing undertaken in the USA. Duration of follow‐up: 8 weeks. | |
Participants | 19 participants Inclusion criteria: Diabetic foot ulcer. Exclusion criteria: Not reported. | |
Interventions | Group A (n = 11): Foam membrane dressing (PolyMem, Ferris). No other details. Group B (n = 8): Wet‐to‐dry saline gauze dressings. No other details. Co‐interventions: None reported. | |
Outcomes | Primary outcome: Ulcer healing (number of ulcers healed; % reduction in wound size). Secondary outcomes: Not reported. | |
Notes | Trial data: Analysis 4.1 Conference abstract. Funding source: Ferris manufacturing corporation (Burr Ridge,IL). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote:"..were randomly assigned…" Comment: Method of generation of random schedule not reported. |
Allocation concealment (selection bias) | Unclear risk | Comment: The process of randomising participants, including who did this is not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No mention of blinding in study report. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: No mention of blinding in study report. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Not clear (conference abstract). |
Selective reporting (reporting bias) | Unclear risk | Comment: Based on conference abstract, protocol not obtained. |
Other bias | Unclear risk | Comment: Funded by commercial organisation. |