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

Chaboyer 2014.

Methods Study design: randomised controlled trial
Study grouping: parallel
Ethics and informed consent: yes
 Follow‐up period: 6 weeks
Sample size estimate: pilot study
ITT analysis: yes number randomised: 92 number analysed: 87
Funding: non‐industry
Pre‐registration: yes
Participants Location: Queensland, Australia
 Intervention group: n = 35control group: n = 35
Mean age: intervention group = 30.6 years (IQR 5.5)control group = 30.7 years (IQR 5.0)
 Inclusion criteria: booked for elective caesarean section; pre‐pregnancy BMI ≥ 30; able to provide consent
 Exclusion criteria: women whose condition changed to require urgent caesarean section; previous participation in the trial; existing infection
Interventions Aim/s: to assess the feasibility of a definitive RCT to test the effectiveness and safety of prophylactic NPWT in obese women after caesarean section
Group 1 (NPWT) intervention: PICO dressing applied over the primarily closed incision by the surgeon in the operating room. Dressing was left on for 4 days or longer if drainage continued, unless soiled or dislodged.
Group 2 (control) intervention: Comfeel dressing applied over the primarily closed incision by the surgeon in the operating room. Dressing was left on for 4 days or longer if drainage continued, unless soiled or dislodged.
 Study date/s: July 2012 to April 2014
Outcomes
  • surgical site infection

  • type of SSI

  • hospital readmission

  • dehiscence; blisters

  • haematoma


Validity of measure/s: CDC definitions and criteria for superficial, deep, and organ/space SSI were used for the primary outcome and SF‐12 for quality of life.
Time points: 1, 2, 3, and 4 weeks postsurgery
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "computer generated 1:1 ratio with blocks of randomly varying sizes"
Allocation concealment (selection bias) Low risk A centralised web‐based randomised service was accessed.
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 Low risk Quote "a separate person ... assessed the outcome and was blinded to the allocation"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 women in the intervention group and 3 in the control group were lost to follow‐up, but an ITT analysis was used.
Selective reporting (reporting bias) Low risk Planned outcomes reported. Protocol registered on ANZCTR.
Other bias Low risk No other biases detected.