Summary of findings for the main comparison. Protease‐modulating matrix dressing regimen compared to any other dressing regimen for healing venous leg ulcers.
| Protease‐modulating matrix dressing compared to advanced dressings/no dressing for venous leg ulcers | |||||
| Patient or population: people with venous leg ulcers Intervention: PMM dressing regimen Comparison: other dressing regimen; different comparators across studies | |||||
| Outcomes | Absolute effect* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | |
| Risk with other dressing regimen | Risk with PMM dressing regimen | ||||
| TIme to complete healing | Estimated median time to complete healing: 3 months | Estimated median time to complete healing: 4.5 months | HR 1.21 (0.74 to 1.97) | 100
(1 RCTǂ) 66 events |
⊕⊕⊝⊝ LOW 1 |
| Difference in estimated median time to complete healing: approximately 1.5 months shorter | |||||
| Proportion of participants healed ‐ short term (4‐8 weeks) | 287 per 1000 | 210 per 1000 | RR 0.73 (0.34 to 1.58) | 207
(2 RCTs) 21 events |
⊕⊝⊝⊝ VERY LOW 2 |
|
Difference: 77 fewer wounds healed per 1000 (95% CI 167 more to 190 fewer) | |||||
| Proportion of participants healed ‐ medium term (12 weeks) | 400 per 1000 | 512 per 1000 | RR 1.28 (0.95 to 1.71) | 192
(4 RCTs) 89 events |
⊕⊕⊝⊝ LOW 3 |
|
Difference: 112 more wounds healed per 1000 (95% CI 20 fewer to 284 more) | |||||
| Proportion of participants healed ‐ long term (over 24 weeks) | 640 per 1000 | 678 per 1000 (512 to 902) | RR 1.06 (0.80 to 1.41) | 100
(1 RCTǂ) 66 events |
⊕⊕⊝⊝ LOW 4 |
|
Difference: 38 more wounds healed per 1000 (95% CI 128 fewer to 262 more) | |||||
| Proportion of participants with 1 or more adverse events at 2‐12 weeks | 172 per 1000 | 178 per 1000 | RR 1.03 (0.75 to 1.42) | 363
(5 RCTs) 99 events |
⊕⊕⊝⊝ LOW 5 |
|
Difference: 6 more adverse events per 1000 (95% CI 43 fewer to 72 more) | |||||
| *The risk without the intervention is based on the median control group risk across studies. The corresponding risk with the intervention (and the 95% confidence interval for the difference) is based on the overall relative effect (and its 95% confidence interval). ǂ Same study (Petkov 1997) CI: Confidence interval; RR: Risk ratio; OR: Odds ratio | |||||
|
GRADE Working Group grades of evidence High: It is very likely that the effect will be close to what was found in the research. Moderate: It is likely that the effect will be close to what was found in the research, but there is a possibility that it will be substantially different. Low: It is likely that the effect will be substantially different from what was found in the research, but the research provides an indication of what might be expected. Very low: The anticipated effect is very uncertain and the research does not provide a reliable indication of what might be expected | |||||
1 Imprecision (downgraded twice): 66 events, wide CI; assumptions in calculation of HR ‐ no censoring (not downgraded); data extracted from graph (not downgraded)
2 Risk of bias (downgraded once): majority of information at high risk of bias. Imprecision (downgraded twice): 21 events and wide CI
3 Risk of bias (downgraded once): majority of information at high risk of bias. Imprecision (downgraded once): 89 events, CI consistent with no effect and benefit
4 Imprecision (downgraded twice): 66 events, wide CI around absolute effect
5 Risk of bias (not downgraded): majority of information at low risk of bias. Imprecision (downgraded twice): 99 events, CI wide around relative effect