DeRiso 1996.
| Methods | Study design: Parallel‐group RCT Location: Indiana, USA Number of centres: 1 Study period: Not stated Funding source: The study was supported by a grant from the August Tomusk Foundation |
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| Participants | Setting: Surgical ICU for postoperative cardiac surgery Inclusion criteria: Patients undergoing cardiac surgery which required cardiopulmonary bypass Exclusion criteria: Intra‐operative death, preoperative infection or intubation, pregnancy, heart and lung transplant recipients, known hypersensitivity to chlorhexidine Number randomised: Unclear Number evaluated: 353 (173 in chlorhexidine group and 180 in control) Baseline characteristics: ‐ Intervention group: Age: 64.1 ± 0.86; M/F: 119/54 ‐ Control group: Age: 63.5 ± 0.84; M/F: 123/57 |
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| Interventions |
Comparison: Chlorhexidine oral rinse versus placebo Experimental group: 0.5 fl ounce (approx 15 ml) of 0.12% chlorhexidine (+ 11.6% ethanol (Proctor & Gamble)) mouthrinse used as oropharyngeal rinse and "rigorously applied" to buccal, pharyngeal, gingival tongue and tooth surfaces for 30 seconds twice daily Control group: Placebo mouthrinse identical in appearance containing base solution and 3.2% ethanol (1/3 of concentration of active solution) All participants also received the standard oral care of the ICU (systemic antibiotics, pressor agents and nutritional support as deemed necessary) |
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| Outcomes | 5 outcome variables were reported: 1. Nosocomial infection rates (upper & lower RTI, UTI, fungaemias, line sepsis, wound & blood infection, other infection) 2. Non‐prophylactic antibiotic use 3. Length of stay in hospital 4. Duration of intubation 5. Mortality |
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| Notes | Sample size calculation: Not reported Unclear duration of mechanical ventilation. Unable to contact author |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "..the pharmacy randomised the patients to either experimental or control group by means of computer driven random number generator" |
| Allocation concealment (selection bias) | Low risk | Allocation was performed in pharmacy and solutions with identical appearance were dispensed for use in ICU |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind. Quote: "…matching placebo…Both were packaged in 120‐mL brown bottles and labelled 'Oral Rinse Solution: Peridex/Placebo Trial Solution' with a 1‐week expiration date" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blind |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of people originally randomised to treatment or control groups not stated |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported (no data for length of stays, duration of ventilation) |
| Other bias | Low risk | No other sources of bias identified |