Sabat 2016.
Methods |
Study design: 1:1 parallel‐group randomised controlled trial Study grouping: parallel Ethics and informed consent: yes Sample size estimate: no Follow‐up period: 4 months ITT analysis: no Funding: not stated Pre‐registration: not stated |
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Participants |
Location: Philadelphia, USA
Intervention group: n = 33 woundscontrol group: n = 30 wounds (total 49 participants) Mean age: not reported Inclusion criteria: people undergoing open vascular surgery involving a groin incision Exclusion criteria: not stated |
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Interventions |
Aim/s: to compare the effect of postoperative negative pressure therapy to conventional dressings on wound occurrences Group 1 (NPWT) intervention: NPWT device Group 2 control: conventional dressing (gauze and Tegaderm) Study date/s: not stated |
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Outcomes |
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Notes | Abstract only; unit analysis | |
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 those recruited appear to have been included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Results for outcomes identified in the methods section were reported. We did not see the original protocol. |
Other bias | High risk | Unit analysis |