Table 2.
Comparison One: Iodine Compared to Normal Saline for Chronic Wound Care | |||||
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Patient or Population: Chronic Wound Care Intervention: Iodine Comparison: Normal Saline | |||||
Outcomes | Anticipated Absolute Effects * (95% CI) | Relative Effect (95% CI) | № of Participants (Studies) | Certainty of the Evidence (GRADE) | |
Risk with Normal Saline | Risk with Iodine | ||||
Proportion of patients with complete wound healing assessed with: visual assessment follow up: range 8 weeks to 12 weeks | 307 per 1000 | 567 per 1000 (390 to 824) |
RR 1.8478 (1.2706 to 2.6874) |
195 (2 RCTs) | ⨁⨁⨁◯ MODERATE a |
Adverse events assessed with: report follow-up: range 8 weeks to 24 weeks | 115 per 1000 | 166 per 1000 (89 to 308) |
RR 1.440 (0.774 to 2.676) |
270 (3 RCTs) | ⨁⨁⨁◯ MODERATE a |
Ulcer healing rate (healing rate) assessed with: planimetry follow-up: range 8 weeks to 24 weeks | Raju et al. [32] found a significantly (p < 0.001) higher percentage of reduction for both formulations of iodine (94.3% and 90.4%) compared to saline (67.8%). Holloway et al. [31] found a rate reported to baseline of 0.04 ± 0.01 cm2/week/cm2 for cadexomer iodine and 0.03 ± 0.01 cm2/week/cm2 for saline. There was no significant difference (p = 0.079). Gwak et al. [28] presented the healing rate with three different visual displays showing the percentage change rate for the length, the width, and the area. They found no difference. |
270 (3 RCTs) | ⨁◯◯◯ VERY LOW b,c,d |
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Pain evaluation (Pain) assessed with: mean rate of change follow up: mean 24 weeks | The mean rate of change in pain scores were −2.44 ± 0.4 for cadexomer iodine and −2.47 ± 0.3 with saline with a p = 0.96. | (1 RCT) | ⨁⨁◯◯ LOW d,e |
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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. |
* The risk in the intervention group (and 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and 95% CI). CI: confidence interval; RR: risk ratio; RCT: randomised controlled trial. (a) Missing outcome data, around 30% of patient losses during follow-up. (b) One study with a high risk of bias due to methodology risk and both studies at risk to outcome reporting. (c) Different results in the two studies. (d) Selective outcome report. (e) Study with an overall high risk of bias.