Pauser 2016.
| Methods |
Study design: randomised controlled trial Study grouping: parallel Ethics and informed consent: yes Sample size estimate: no Follow‐up period: 10 days ITT analysis: yes number randomised: 21 number analysed: 21 Funding: "Prevena wound treatment system was provided by KCI free of charge" Pre‐registration: no |
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| Participants |
Location: Nuremberg, Germany
Intervention group: n = 11control group: n = 10 Mean age: intervention group = 81.6 ± 5.2 yearscontrol group = 82.6 ± 8.6 years Inclusion criteria: patients with femoral neck fracture who were scheduled for hip hemiarthroplasty Exclusion criteria: not stated |
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| Interventions |
Aim/s: "to evaluate different aspects of wound healing after fractures of the femoral neck treated by hemiarthroplasty" Group 1 (NPWT) intervention: the iNPWT group was treated with a PREVENA system (KCI, San Antonio, Texas). The PREVENA system was left on the wound for 5 days including the day of surgery. Group 2 control: control group received the standard wound dressing of our department, consisting of a dry wound coverage (compresses attached to the skin). Study date/s: not reported |
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| Outcomes |
Validity of measure/s: ultrasound was used as a standardised imaging modality to detect seromas in the wound area. Time points: day 5 and day 10 after surgery |
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| Notes | Investigator contacted for additional details. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information given. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information given. |
| 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 | Insufficient information given. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All those recruited appear to have been included in the analysis. |
| Selective reporting (reporting bias) | High risk | Only seroma was reported, not SSI. |
| Other bias | Unclear risk | Data for the NPWT group reported at day 5 and day 10, but data for the control group only reported overall. |