Kremer 1991.
Methods | A randomised controlled, open‐label, parallel‐group trial | |
Participants | 1. Setting: the trial was conducted in an outpatient (Table 2) setting in northern Israel. The recruitment process of participants was NR
2. Number of participants randomised: 40 3. Sex (men/women): 14/18 (8 participants were lost to follow‐up and their details are NR) 4. Mean age (range): treatment group‐ 63.2 (42 ‐ 75), control group‐ 65.5 (32 ‐ 75) 5. Area of body involved: leg. 2 participants from the control group suffered upper extremity infections 6. Number of episodes of cellulitis prior to intervention: ≥ 2 |
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Interventions | Study groups:
Concomitant treatment: local antifungal treatment for tinea pedis Duration of treatment: 18 months Follow‐up:during treatment phase‐monthly, after treatment phase‐ NR |
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Outcomes | 1. The number of participants with repeat episodes of cellulitis 2. The number of repeat episodes of cellulitis 3. The number of participants requiring hospitalisation 4. The number of adverse drug reactions |
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Notes | Criteria for diagnosis of cellulitis: NR.
Comment: the report mentioned that during follow‐up participants with "a relapse" came to the clinic and were treated according to "clinical findings" Funding source and Declaration of interest: NR. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The paper did not provide details |
Allocation concealment (selection bias) | Unclear risk | The paper did not provide details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | This was an open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This was an open‐label study |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8 participants were lost to follow‐up (20% of participants in the study) and the paper did not detail to which groups they were assigned; we conducted a 'per protocol' analysis |
Selective reporting (reporting bias) | Unclear risk | There was insufficient information |
Similarity of groups at baseline (baseline imbalance bias) | Low risk | Baseline characteristics were reported and balanced (Table 1 in the article). |
Early termination (early stopping bias) | High risk | Quote: "After I8 months' follow‐up the differences between the two groups were dramatic, and led us to conclude the study" Comment: the study was terminated based on results and did not report sample size calculation, formal interim analysis or a formal stopping rule |
Other bias | Low risk | No other sources of potential bias were found |