Skip to main content
. 2019 Mar 26;2019(3):CD009261. doi: 10.1002/14651858.CD009261.pub4

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
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
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
Outcomes
  • SSI rate


Validity of measure/s: not described
Time points: a daily evaluation through hospitalisation and a 15‐ and 30‐day evaluation
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