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

Lozano‐Balderas 2017.

Methods Study design: randomised controlled trial
 Ethics and informed consent: ethics approved
Sample size calculation: no
ITT analysis: yes number randomised: 81 number analysed: 81
Follow‐up period: healed (when in hospital) or in a 30‐day period after surgery (if discharged)
Funding: non‐industry
Pre‐registration: yes
Participants Location: Mexico
 Intervention group: n = 25control group: n = 27 (3 arms: delayed primary closure group: n = 29)
Median age (IQR): intervention group = 32 (22 to 46);control group = 30 (20 to 43)
 Inclusion criteria: minimum age of 18; a laparotomised wound with class III or IV (contaminated/dirty‐infected) surgical wounds
 Exclusion criteria: not specified
Interventions Aim/s: to compare infection rates between primary, delayed primary, and vacuum‐assisted closures in contaminated/dirty‐infected surgical wounds
Group 1 (NPWT) intervention: the VAC was used with routine changes of dressings every 48 hours until healthy granulation tissue was found and a surgeon decided to close it.
Group 2 (control) intervention: subcutaneous tissue was approximated with polyglycolic acid, and polypropylene was used for the skin.
 Study date/s: January to July 2014
Outcomes
  • SSI


Validity of measure/s: according to the CDC Surgical Wound Classification
Time points: daily when in hospital or in a 30‐day period after surgery
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were allocated to each group with the software Research Randomizer® (Urbaniak, G. C., & Plous, S., Version 4.0)"
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 High risk Outcome assessors were aware of group allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 81 participants were enrolled and analysed.
Selective reporting (reporting bias) Low risk Expected outcomes reported. Protocol retrospectively registered on ClinicalTrials.gov (NCT02649543).
Other bias Low risk No other biases detected.