Anitua 2008.
| Methods | Design: Randomised open‐label controlled pilot trial Number of participant centres: 1 Setting: Hospital Country: Spain Unit of randomisation: the patient Unit of analysis: the patient Follow‐up: 8 weeks |
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| Participants | Number randomised (patients): 15 (Group 1 experimental: 8 and Group 2 control: 7) Number ulcers assessed: 15 Wound aetiology: mixed 10, venous ulcers 4, pressure ulcers and 1 other Age (mean and SD): Group 1: 45 (20) Group 2: 61 (16) Sex: 7 F/8 M Inclusion criteria: Adults of both sexes with chronic ( > 4 weeks) skin ulcers of less than 12 cm in diameter or Wagner grade II/III Exclusion criteria: ulcer of arterial origin; infection; insulin‐dependent diabetes mellitus; vasculitis; lupus; cryoglobulinemia; haematological abnormality; epilepsy; solid tumour; anticoagulants; immunosuppressant drugs; anaemia; pregnant women or inadequate birth control | |
| Interventions | At baseline all patients received conventional treatment (cleansing, debridement, and wet cure with physiological saline and sterile gauzes) After randomisation it was not reported if the participants randomised to the experimental group continued to receive the conventional treatment in addition to the weekly treatment of autologous PRGF Experimental group: Autologous PRGF Control group: Conventional treatment Length of treatment: 8 weeks |
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| Outcomes | Mean percentage of surface healed* Lesion area* Adverse events *Measures were made from photographic records using Mouseyes software | |
| Notes | Funding: The Biotechnology Institute provided the PRGF System® device. Baseline characteristics were not similar between groups. Patients in the control group were older, had longer ulcer duration and larger wound sizes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned according to a computer generated randomisation table to wound care with PRGF (experimental group) or standard wound care (control group)" Comments: randomisation sequence was generated by computer |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants (performance bias and detection bias) | High risk | Quote: "...open‐label, standard care‐controlled pilot clinical trial" Comments: The clinical trial was open. No masking of participants |
| Blinding of personnel (performance and detection bias) | High risk | Quote: "...open‐label, standard care‐controlled pilot clinical trial" Comments: The clinical trial was open. No masking of care provider |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "...open‐label, standard care‐controlled pilot clinical trial" Comments: The clinical trial was open. No masking of outcome assessor |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 40% of patients were lost to follow‐up; Group 1: 3/8 (37.5%) Group 2: 3/7 (42.8%) Comments: this represents a high level of loss (over 30%) |
| Selective reporting (reporting bias) | Low risk | The results of all outcomes prespecified in the methods of the trial report were presented. The trial protocol was not sought |