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. 2019 Mar 26;2019(3):CD009261. doi: 10.1002/14651858.CD009261.pub4

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
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
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
Outcomes
  • seroma


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
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.