Summary of findings 1. Compression bandages or stockings compared with no compression for treating venous leg ulcers.
Compression bandages or stockings compared with no compression for treating venous leg ulcers | ||||
Patient or population: people with venous leg ulcers Setting: community and acute‐care settings Intervention: compression bandages or stockings Comparison: no compression | ||||
Outcomes | Impact | № of participants (studies) | Certainty of the evidence (GRADE) | Comments |
Time‐to‐complete wound healing follow‐up: range 1 day to 12 months | 5 studies (733 participants) with time‐to‐event data: HR 2.17 (95% CI 1.52 to 3.10)a | 733 (5 RCTs) | ⊕⊕⊕⊝ Moderateb | There is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression |
Proportion of wounds completely healed during follow‐up follow up: range 1 day to 12 months | 8 studies (1120 participants) with analysable data: RR 1.77 (95% CI 1.41 to 2.21) Two studies (95 participants) without analysable data: 1 study reported 71% of leg ulcers completely healed in short‐stretch bandages and 25% in usual care. 1 study reported 82% of 21 participants with ulcers healed when using compression plus local povidone‐iodine (Betadine) and 62% of 21 participants with ulcers healed when using local povidone‐iodine (Betadine) |
1215 (10 RCTs) |
⊕⊕⊕⊝ Moderatec | People treated with compression bandages or stockings probably have more completely healed venous leg ulcers during follow‐up to 12 months than people not in compression |
Adverse events follow‐up: range 8 weeks to 12 months | 3 studies (585 participants) with adverse event data that were systematically collected: RR 0.98 (95% CI 0.25 to 3.80) a | 585 (3 RCTs) | ⊕⊝⊝⊝ Very low d,e,f | It is uncertain whether there is any difference in the risk of adverse events associated with using compression and not using compression |
Participant health‐related quality of life/health status follow‐up: 12 weeks to 12 months | Two studies (426 participants): pooled MD in the total score of the Charing Cross Venous Ulcer Questionnaire (lower scores = better quality of life) −6.87 (95% CI −13.10 to −0.64) between using compression bandages or stockings and no compression, but data analysis showed no difference in the physical component, mental component, and functional status of the SF‐12. Two studies without analysable data (433 participants): 1 study (233 participants) stated that, for most dimensions of the SF‐36 and EuroQol, health status deteriorated over time but was not different between 4‐layer bandages and usual care. 1 study (200 participants) reported a statistical difference in some dimensions of the SF‐36 (including physical function, role‐physical, mental health) and the disease‐specific quality of life instrument for chronic lower limb venous insufficiency (CIVIQ) (physical, social, and global dimensions) but not in others |
859 (4 RCTs) |
⊕⊕⊝⊝ Lowg | Compression bandages or stockings may improve participant health‐related quality of life for some (but not all) aspects during the follow‐up of 12 weeks to 12 months in comparison with no compression |
Cost effectiveness follow‐up: 12 weeks and 12 months | Two studies without incremental mean cost per incremental gain in benefit: 1 study (53 participants) reported that the short‐stretch bandage was more cost‐effective than usual care as it could be washed and reused repeatedly. 1 study (200 participants) showed that the median cost per leg healed was significantly less for 4‐layer bandages than dressings (P = 0.04). 1 study (233 participants) with incremental mean cost per incremental gain in benefit: incremental cost‐effectiveness ratio = GBP 2.46 (95% CI −31.94 to 99.12) per ulcer‐free week between 4‐layer bandage in leg ulcer clinics and no compression |
486 (3 RCTs) |
⊕⊝⊝⊝ Very low h,i,j | It is uncertain whether compression bandages or stockings are cost effective compared with no compression in wound healing |
Mean pain score median follow‐up period 12 weeks (minimum 12 weeks maximum 12 months) | Two studies with 426 participants and another study with 69 ulcers reported analysable data, with pain measured by either a 10‐point visual analogue scale or a scale with grades from 1 to 10: pooled MD −1.39 (95% CI −1.79 to −0.98). Two studies without analysable data (433 participants), neither reported the range of scales used: 1 study (233 participants) stated that people treated with 4‐layer bandages were more likely to experience a reduction in leg ulcer pain per month than those using usual care; and another study (200 participants) reported a lower median of pain scores among those using 4‐layer bandages than those using dressings (median 18.8, IQR 6.3 to 37.5; and 31.3, 18.8 to 43.8, respectively; P = 0.14). |
859 participants and 69 ulcers in other participants (5 RCTs) |
⊕⊕⊕⊝ Moderatek | The use of compression probably reduces mean pain score compared with no compression. |
*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; HR: Hazard Ratio; IQR: interquartile range; MD: mean difference; 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. |
aOne included study (84 participants with 87 ulcers) in these analyses reported clustered data whilst the other studies reported data by participant; the absolute effect could not be estimated directly. bDowngraded once for risk of bias (one study with clustered data and another small study were at high overall risk of bias in domains other than performance bias, and the other three studies with most of the data in this synthesis were at unclear overall risk of bias). cDowngraded once for risk of bias (six studies having 569/1215 (46.8%) participants were at high risk of bias in the domains other than performance bias and the other four were at unclear risk of bias in some but not all domains). dDowngraded once for risk of bias (two studies with the larger numbers of participants were at high risk of bias in some domains and one study contributing 30.6% weight was at unclear risk of bias). eDowngraded twice for substantial inconsistency as the clustered data were inconsistent with the data reported by participant. fDowngraded once for imprecision because the CIs appeared to include the possibility of both benefit and harm as well as no effect. gDowngraded twice for substantial inconsistency due to the variation of the reported results, particularly in terms of health status. hDowngraded once for risk of bias (one small study was at high overall risk of bias in domains other than performance bias and the other two studies were at unclear risk of bias in some domains). iDowngraded once for indirectness (results from two studies did not appear to be expressed as incremental mean cost per incremental gain in benefit). jDowngraded once for inconsistency in terms of cost‐effectiveness results between studies. kDowngraded once for risk of bias as two (of all six included) studies with 345 participants (a small proportion) were at high overall risk of bias.