De la Brassinne 2006.
Study characteristics | ||
Methods | Design: open; RCT Country: Belgium Setting: hospital Sample size calculation: not reported Ethical approval: was granted after the medical ethics committee approved the project (Ethics Committee of the Medicine Faculty of Liege University, Belgium). Informed consent: was obtained after fully advising the participants about the purpose and consequences of the study. |
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Participants | Total sample: 20 hospitalised participants with chronic leg ulcers of venous origin Inclusion criteria: men and women, mobile, aged 40–70 years and chronic leg ulcers of venous origin with exudate Exclusion criteria: none specified Numbers randomised
Gender: 13 women and 7 men Mean age: 61 years (range 45–70 years) ABPI: not reported Unit of randomisation: participant Unit of analysis: participant Ulcer infection: not reported Ulcer duration (current): 2.25 years (range 0.5–10 years) in both groups Baseline ulcer surface
Baseline volume measurement
Data collected: ulcer dimension by planimetry and volume of the ulcer at day 7, 14 and 28 |
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Interventions | Group 1: hydrogel dressing (IntraSite Gel) Group 2: alginate dressing (Flaminal gel) *Both groups had the wound debrided and cleaning with saline before the dressing was applied. Description of compression therapy: not reported Length of treatment: 4 weeks Follow‐up: 4 weeks Comments: * The surface measurement of the ulcer was made using acetate tracing (Opsite Flexigrid from Smith & Nephew Healthcare). * The volume measurement of the ulcer was made using high algin impression material (Jeltrate mould from Dentsply Caulk International) |
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Outcomes | Complete wound healing: not reported Incidence of wound infection: not reported Change in ulcer size: reported, planimetry used to measure the wound at baseline, 7, 14 and 28 days of treatment and volume measured on same days Mean percentage surface reduction at day 14 (P < 0.01)
Mean percentage surface reduction at day 28 (P ≤ 0.01)
Time to ulcer healing: not reported Recurrence of ulcer: not reported Health‐related quality of life: not reported Pain: not reported Costs: not reported |
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Notes | Number of participants withdrawing and reasons: no withdrawals Funding: UCB‐Belgium |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The study was performed in two‐armed parallel groups, open and randomised". Comment: no further description of method of randomisation provided. |
Allocation concealment (selection bias) | Unclear risk | Comment: no mention of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: open study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: open study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: the study started with 20 participants and the authors did not report dropouts. All the participants were included in final analysis. |
Selective reporting (reporting bias) | Low risk | Comment: all trial outcomes described in the methods section of the report were included in the results section. Unable to obtain RCT protocol (no response to email sent to trial author). |
Other bias | Low risk | Comment: there was no report regarding the balance between men and women allocated on each group; however, the baseline ulcer surface area and volume did not differ between groups. |