DiMuzio 2017.
Methods |
Study design: randomised controlled trial
Study grouping: parallel Ethics and informed consent: not provided Follow‐up period: 30 days Sample size calculation: not stated ITT analysis: number randomised: 120 number analysed: 120 Funding: not stated Pre‐registration: not stated |
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Participants |
Location: Philadelphia, USA
Intervention group (high risk): n = 59control group (high risk): n = 60 (3 arms: low risk: n = 21) Mean age: not provided Inclusion criteria: femoral incisions closed primarily following elective vascular surgery Exclusion criteria: none stated |
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Interventions |
Aim/s: to prospectively evaluate negative pressure therapy as a means to decrease wound complications and associated healthcare costs Group 1 (NPWT) intervention: NPWT Group 2 (control) intervention: standard gauze dressing Study date/s: not provided |
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Outcomes |
Validity of measure/s: not provided Time points: over 30 days |
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Notes | Conference abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk |
Evidence for participants: not possible Comment: unlikely to affect outcomes Evidence for personnel: not possible Comment: unlikely to affect outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 140 (3 arms) were enrolled and analysed. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Unclear risk | No other biases detected. |