Leon 2016.
Methods |
Study design: prospective, randomised, multicentre study Study grouping: parallel Ethics and informed consent: not reported Follow‐up period: not reported Sample size estimate: not reported ITT analysis: yes number randomised: 81 number analysed: 81 Funding: not reported Pre‐registration: not reported |
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Participants |
Location: Spain
Intervention group: n = 47control group: n = 34 Mean age (SD): not reported Inclusion criteria: patients undergoing open and programmed colorectal surgery Exclusion criteria: not stated |
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Interventions |
Aim/s: to evaluate the benefits of negative pressure therapy to reduce surgical site infection rate in open colorectal surgery Group 1 (NPWT) intervention: NPWT Group 2 (control) intervention: usual dressing group Study date/s: not reported |
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Outcomes |
Validity of measure/s: not described Time points: a daily evaluation through hospitalisation and a 15‐ and 30‐day evaluation |
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Notes | Only the abstract was available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
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 stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All enrolled participants were accounted for in the analyses. |
Selective reporting (reporting bias) | Unclear risk | Not stated |
Other bias | Unclear risk | Abstract only |