Senet 2003.
| Methods | Design: Randomised double‐blind placebo controlled trial Number of participating centres: 1 Setting: Hospital Country: France Unit of randomisation: the patient Unit of analysis: the patient Follow‐up: 16 weeks |
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| Participants | Number randomised (patients): 15 (8 in the experimental group and 7 in the control group) Number ulcers: 1 per patient Wound aetiology: Chronic venous leg ulcer Age (mean): 72.3 years Sex: 6 F/7 M Inclusion criteria: Adults of both sexes with chronic skin venous leg ulcers of at least 2 months duration; ulcer size between 3 and 50 cm2; established venous disease; homolateral ankle‐brachial index > 0.8 or peripheral pulses present; normal platelet count, Hb > 11g/dL and albumin > 35 g/L Exclusion criteria: pregnancy; allergy to hydrocolloid dressing; systemic diseases; treatment with cytostatics or corticosteroids; ulcers with exposed tendons or bones; infected ulcers; poor compliance with compression therapy; positive serology to lues, Hepatitis B, Hepatitis C, HIV, Human T Lymphocyte virus I and II. Diabetes if the concentration of blood glucose was > 2 g/L |
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| Interventions | Experimental group: topical use of frozen autologous platelet suspension in saline solution Control group: saline solution (placebo) Patients received standard topical and pressure treatment. The frequency of treatment was 3 times/week at hospital. Length of treatment: 12 weeks |
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| Outcomes | Ulcer healing, rate of ulcer healing and adverse effects. Other outcomes: local expression of the vascular endothelial growth factor; local expression of the keratocytes growth factor; local expression of the interleukin‐8; local expression of the metalloproteinase‐1 tissular inhibitor | |
| Notes | Supported by the Institut National de la Santé et de la Reserche Medicale and Coloplast. Both groups were homogeneous at baseline | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Immediately after collection and preparation of platelets, patients were randomized to receive either placebo or platelets" Comments: The paper states this was randomised but gives no further detail |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants (performance bias and detection bias) | Low risk | Quote: "After the wound was cleansed with normal saline solution, the appropriate volume of either FAP or placebo was applied to the wound surface with a syringe. FAP and placebo appeared identical" Comments: The treatments (experimental and control) were of similar appearance and therefore it was judged that the participant was properly blinded |
| Blinding of personnel (performance and detection bias) | Low risk | Quote: "After the wound was cleansed with normal saline solution, the appropriate volume of either FAP or placebo was applied to the wound surface with a syringe. FAP and placebo appeared identical" Comments: The treatments (experimental and control) were of similar appearance and therefore it was judged that the care giver was properly blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "After the wound was cleansed with normal saline solution, the appropriate volume of either FAP or placebo was applied to the wound surface with a syringe. FAP and placebo appeared identical" Comments: The treatments (experimental and control) were of similar appearance. The outcome assessor was judged to be blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of total losses was low (13.3%), 1(12.5%) patient in experimental group and 1(14.3%) patient in control group |
| Selective reporting (reporting bias) | Low risk | The results of all outcomes were reported. The trial protocol was not sought |