Eriksson 1984a.
Study characteristics | ||
Methods |
Study objective: to evaluate different methods of topical treatment of venous leg ulcers Trial design (e.g. parallel group) including research sites: parallel group Follow‐up period: 8 weeks Number of arms: 3 Study start date and end date: not given Care setting: not reported |
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Participants |
Study population: people with venous leg ulcers. Eligibilitycriteria: exclusion criteria are overt diabetes mellitus, manifest arterial insufficiency, clinical picture of erysipelas or cellulitis Sex (M:F): overall 13:40 (among all 53 participants who were enrolled in an unrelated trial prior to the compression trial) Age (years): mean 70.1 (among all 53 participants who were enrolled in an unrelated trial prior to the compression trial) Duration of leg ulcers: not reported Baseline leg ulcer area: not reported Group difference: comparable in terms of all variables except for high blood glucose levels, and history of previous thrombosis (among participants of the trial 1) Total number of participants: 44 participants in the compression trial Unit of analysis (including number of ulcers per person): participants Unit of randomisation (e.g. leg ulcer, limb, or participant): participants |
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Interventions |
Intervention characteristics Porcine skin dressing
Metallina aluminium foil dressing
Double‐layer bandage
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Outcomes |
Time‐to‐complete wound healing
Proportion of wounds completely healed during follow‐up
Adverse events
Participant health‐related quality of life/health status
Cost effectiveness
Mean pain score
Outcomes that are not considered in this review but reported in trials:
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Identification |
Publication type/ status (e.g. conference abstract): full paper Trial protocol: not reported Source of funding: not described Country of origin: Sweden Contact information: G. Eriksson, Departments of Dermatology, Dandeyd Hospital, Stockholm, Sweden |
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Notes | Eriksson 1984a presented results of 2 trials: the 2‐week trial 1 compared 0.9% sodium chloride in sterile water with dextranomer beads through randomising 53 participants with venous leg ulcers and 9 patients excluded because of ulcer healing or reasons unrelated to the trial 2 prior to the conduct of trial 2. With the remaining 44 participants, trial 2 was undertaken to compare 2 dressing methods with a compression bandage method. Only data from trial 2 were extracted for this review | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "... the patients were randomised for three different treatments." Comment: unclear risk of bias because the randomisation method is not described |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Outcome group: ulcer healing Quote: "The investigation was designed as a randomised open trial" Comment: high risk of bias because this trial is claimed to be "open" label. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome group: ulcer healing Quote: "Stereophotogrammetry was used as an objective method of measurement of the healing process" Comment: low risk of bias because ulcer outcomes are measured using the objective stereophotogrammetry as the authors claim |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information provided. |
Selective reporting (reporting bias) | Low risk | Comment: the authors claimed to evaluate time to ulcer healing but did not present relevant data. The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias. |