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

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
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
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
Outcomes
  • SSI

  • wound dehiscence

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