Summary of findings 5. Hyaluronic acid + hydrocolloid compared with hydrocolloid for leg ulcers.
| Hyaluronic acid + hydrocolloid compared with hydrocolloid for leg ulcers | ||||||
| Patient or population: people with leg ulcers Setting: inpatients or outpatients Intervention: hyaluronic acid + hydrocolloid 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 + hydrocolloid | |||||
| Complete ulcer healing (42 days) | Study population | RR 0.98 (0.26 to 3.76) | 125 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if hyaluronic acid + hydrocolloid affects complete ulcer healing when compared with hydrocolloid. | |
| 65 per 1000 | 63 per 1000 (17 to 243) | |||||
| Time to complete wound healing ‐ not reported | No studies provided evidence for this outcome. | |||||
| Adverse events | Study population | RR 0.79 (0.22 to 2.80) | 125 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in adverse events between hyaluronic acid + hydrocolloid and hydrocolloid. | |
| 81 per 1000 | 64 per 1000 (18 to 226) | |||||
| Health‐related quality of life ‐ not reported | No studies provided evidence for this outcome. | |||||
| Pain (VAS, mm) at follow‐up | The mean score was 10.0. | The mean score was 12.1. | MD 2.10 (5.81 lower to 10.01 higher) | 125 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in pain between treatments. |
| Change in ulcer size to at least 90% | Study population | RR 2.11 (0.92 to 4.82) | 125 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 | It is uncertain if there is a difference in change in ulcer size between treatments. | |
| 113 per 1000 | 238 per 1000 (104 to 544) | |||||
| *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; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; VAS: visual analogue scale | ||||||
| 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 high risk of bias for blinding of participants and personnel and outcome assessment. 2Downgraded twice for imprecision due to small numbers of participants and wide confidence intervals.