Summary of findings 6. Hyaluronic acid compared with hydrocolloid for leg ulcers.
| Hyaluronic acid compared with hydrocolloid for leg ulcers | ||||||
| Patient or population: people with leg ulcers Setting: general clinic (20 centres) Intervention: hyaluronic acid Comparison: hydrocolloid | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with hydrocolloid | Risk with hyaluronic acid | |||||
| Complete ulcer healing Follow‐up: 56 days | Data on complete wound healing were not properly presented at the endpoint (56 days). There was only a citation relating to 27 dropouts, including 12 due to ulcer healing, without specifying to which groups they belonged. | ‐ | 143 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in complete wound healing between treatments. | |
| Time to complete wound healing ‐ not reported | No studies provided evidence for this outcome. | |||||
| Adverse events Follow‐up: 56 days | The study report states that 77 adverse events were reported in 42 participants during the study; however, most of them were not localised to the ulcer. | ‐ | 143 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in adverse events between treatments. | |
| Health‐related quality of life ‐ not reported | No studies provided evidence for this outcome. | |||||
| Pain | No studies provided evidence for this outcome. | |||||
| Change in ulcer size > 40% | Study population | RR 1.02 (0.84 to 1.25) | 143 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in change in ulcer size between treatments. | |
| 718 per 1000 | 736 per 1000 (602 to 900) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded twice for risk of bias due to unclear risk of bias for allocation and high risk of bias for blinding of participants and personnel. 2Downgraded twice for imprecision due to small numbers of participants and events and wide confidence intervals.