Belcaro 2003.
| Methods | Randomised controlled trial conducted in Italy | |
| Participants | 20 people with venous ulceration with minimum and maximum ulcer diameters > 2 cm and < 5 cm
Group 1: 10
Group 2: 10 Mean ± SD baseline ulcer area (cm2): Group 1: 3.98 ± 0.4; Group 2: 3.76 ± 0.4 Mean ± SD baseline ulcer duration (months): Group 1: 2.9 ± 2.0; Group 2: 2.5 ± 1.0 All participants were treated with systemic antibiotics for 15 to 20 days before the start of trial treatment to resolve clinical infection |
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| Interventions | 1. The lower limb and the area of ulceration were cleaned with water and neutral soap; skin was dried with tissue paper; 2 g of placebo cream was applied to the ulcerated area and surrounding skin, and compression below‐knee stockings were applied 2. 2 g hydrogen peroxide cream 1% was used instead of placebo | |
| Outcomes | After 10 days, median decrease in ulcerated area:
1. 11%
2. 35%
(P value < 0.05) Mean percentage ulcer area remaining: 1. 89% 2. 65% (P value < 0.05) Improvement in microcirculatory parameters was significant in Group 2 No adverse effects reported |
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| Notes | No information given about withdrawals | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "the effects of a new compound (Crystacide) were assessed in a randomised controlled study"; it was not stated how the sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | No information given |
| Blinding (performance bias and detection bias) Participant blinded to the intervention | Low risk | The trial authors stated that participants in Group 1 received the same treatment and that: "A placebo cream, comparable in aspect and density to Crystacide, was used. The creams were given to patients in containers without labels" |
| Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | No information given |
| Incomplete outcome data (attrition bias) Drop out rate described | Unclear risk | No mention of dropouts or withdrawals |
| Incomplete outcome data (attrition bias) Drop out rate acceptable | Unclear risk | No information given |
| Incomplete outcome data (attrition bias) ITT analysis | Unclear risk | No exclusions described |
| Baseline factors comparable | Unclear risk | Mean values appear to have been reported for ulcer size and ulcer duration, and so difficult to judge comparability |