Stacey 2000.
| Methods | Design: Randomised double‐blind placebo controlled trial Number of participant centres: 1 Setting: Departament of Surgery Country: Australia Unit of randomisation: the patient Unit of analysis: the patient Follow‐up: 9 months |
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| Participants | Number randomised (patients): 86 (42 in the experimental group and 44 in the control group) Number ulcers: 1 per patient Wound aetiology: Chronic venous leg ulcer Age (median): 70 years Sex: 50 F/36 M Inclusion criteria: Adults of both sexes with demonstrated chronic venous ulcer Exclusion criteria: Any patient who did not meet the inclusion criteria |
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| Interventions | Experimental group: growth factors obtained from autologous platelet lysate Control group: placebo Topical application 2 times a week associated with gauze and pressure dressing. Length of treatment: until ulcer healing or for a 9‐month period |
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| Outcomes | Ulcer healing. Time to ulcer healing. Platelet growing factor and epidermic growing factor concentrations in the platelet lysate. Mitogenic ability of the platelet lysate in a fibroblast culture | |
| Notes | Both groups were homogeneous at baseline. The study was supported by The Medical Research Foundation of Western of Australia and Beiersdorf A.G. (Germany) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomisation was by a sealed envelope system which was opened after all entry criteria were fulfilled and the patient had given informed consent" Comments: How the randomisation sequence was generated was not specified |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was by a sealed envelope system which was opened after all entry criteria were fulfilled and the patient had given informed consent" Comments: The allocation concealment was by sealed envelope, although this was not described as an opaque and sequentially sealed envelope we have judged this to be adequate |
| Blinding of participants (performance bias and detection bias) | Unclear risk | Quote: "The aim of this study was to undertake a double blind placebo‐controlled trial...." Comment: The process of intervention concealment to participants was not specified |
| Blinding of personnel (performance and detection bias) | Unclear risk | Quote: "The patients were attended twice weekly for application of either platelet lysate or placebo and for replacement of dressings and bandages" Comment: The process of intervention concealment was not specified |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "All patients had their leg ulcers treated at the leg ulcer clinic at Fremantle Hospital. They attended twice weekly for application of either platelet lysate or placebo and for replacement of dressings and bandages" Comment: It is unknown if the outcome assessor was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses in both groups were 12.8%, 5 (11.9%) patients in the experimental group and 6 (13.6%) in the control group |
| Selective reporting (reporting bias) | Low risk | Results of all outcomes specified in methods are given. The trial protocol was not sought |