Summary of findings 2. Active topical agent versus placebo/control for preventing pressure ulcers.
| Active topical agent versus placebo/control for preventing pressure ulcers | ||||||
|
Patient or population: individuals at risk of pressure ulcer development
Settings: nursing homes (1 trial); geriatric medicine (3 trials)
Intervention: active topical agent Comparison: placebo/control | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo/control | Active topical agent | |||||
|
Pressure ulcer incidence: active lotion vs placebo Assessed with observation Follow‐up: 3 weeks |
Study population | RR 0.73 (0.45 to 1.19) | 167 (1 RCT) | ⊕⊝⊝⊝ Very low1 | There was no clear difference in pressure ulcer incidence (19/76 (25%) active lotion, vs 31/91 (41%) placebo, very low‐certainty evidence) | |
| 341 per 1000 | 249 per 1000 (153 to 405) | |||||
|
Pressure ulcer incidence: DMSO cream vs placebo Assessed with observation Follow‐up: 4 weeks |
Study population | RR 1.99 (1.10 to 3.57) | 61 (1 RCT) | ⊕⊕⊝⊝ Low2 | DMSO cream may increase the risk of pressure ulcer incidence (placebo 10/32 (31.3%) vs DMSO 18/29 (62.1%), low‐certainty evidence) | |
| 312 per 1000 | 622 per 1000 (344 to 1000) | |||||
|
Pressure ulcer incidence: Conotrane vs placebo Assessed with observation Follow‐up: 24 weeks |
Study population | RR 0.74 (0.52 to 1.07) | 258 (1 RCT) | ⊕⊝⊝⊝ Very low3 | There was no clear difference in pressure ulcer incidence (35/129 (27%) Conotrane, vs 47/129 (36%) placebo, very low‐certainty evidence) | |
| 364 per 1000 | 270 per 1000 (189 to 390) | |||||
|
Pressure ulcer incidence: Prevasore vs control Assessed with observation Follow‐up: 3 weeks |
Study population | RR 0.33 (0.04 to 3.11) | 120 (1 RCT) | ⊕⊝⊝⊝ Very low4 | There was no clear difference in pressure ulcer incidence (1/60 (2%) Prevasore, vs 3/60 (5%) control, very low‐certainty evidence) | |
| 50 per 1000 | 17 per 1000 (2 to 155) | |||||
| Stage 3 pressure ulcer incidence: Conotrane vs placebo | Study population | RR 1.25 (0.34 to 4.55) | 258 (1 RCT) | ⊕⊝⊝⊝ Very low3 | There was no clear difference in pressure ulcer incidence stage III (5/129 (4%) Conotrane, vs 4/129 (3%) placebo, very low‐certainty evidence) | |
| 31 per 1000 | 39 per 1000 (11 to 141) | |||||
| Stage 4 pressure ulcer incidence: Conotrane vs placebo | Study population | RR 0.33 (0.01 to 8.11) | 258 (1 RCT) | ⊕⊝⊝⊝ Very low3 | There was no clear difference in pressure ulcer incidence stage IV (0/129 (0%) Conotrane, vs 1/129 (0.008%) placebo, very low‐certainty evidence) | |
| 8 per 1000 | 3 per 1000 (0 to 63) | |||||
| Adverse events: active lotion vs placebo | Study population | OR 6.14 (0.29 to 129.89) | 167 (1 RCT) | ⊕⊝⊝⊝ Very low1 | There was no clear difference in adverse events (2/76 (3%) active lotion, vs 0/91 (0%) placebo, very low‐certainty evidence) | |
| 0 per 1000 | 0 per 1000 (0 to 0) | |||||
| *The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (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; OR: odds 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 high risk of attrition bias and unclear risk of selection bias and downgraded once for serious imprecision due to a wide confidence interval. 2 Downgraded once for unclear risk of selection bias and downgraded once for imprecision due to a wide confidence interval. 3Downgraded twice for risk of bias due to selection bias and other bias due to baseline imbalance; and downgraded once for serious imprecision due to a wide confidence interval. 4Downgraded twice for risk of bias due to selection bias and other bias due to manufacturer involvement in one trial and baseline imbalance; and downgraded twice for very serious imprecision due to a wide confidence interval.