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

Gillespie 2015.

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: 70 number analysed: 70
Funding: non‐industry
Pre‐registration: yes
Participants Location: Queensland, Australia
 Intervention group: n = 35control group: n = 35 (primary hip arthroplasty)
Mean age: intervention group = 30.6 years (SD 5.5)control group = 30.7 years (SD 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; unable to speak English
Interventions Aim/s: to determine the feasibility of conducting a larger trial
Primary outcome/s: surgical site infection
Secondary outcome/s: type of SSI; wound complications; hospital length of stay; hospital readmission
Group 1 (NPWT) intervention: PICO dressing applied over the primarily closed incision by the surgeon in the operating room. On day 5 the dressing was changed to OPSITE Post‐Op Visible.
Group 2 (control) intervention: Comfeel dressing reinforced with 2 absorbent dressings, and then with a self adhesive, non‐woven tape, which was applied over the primarily closed incision by the surgeon in the operating room. Participants were discharged with their dressing intact.
 Study date/s: March 2013 to May 2014
Outcomes
  • SSI

  • bruising

  • bleeding

  • dehiscence

  • blisters

  • haematoma

  • seroma

  • hospital readmission

  • Cost of dressings


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 (QoL reported in the Heard 2017 study).
Time points: 30 days and 6 weeks postsurgery
Notes Investigator contacted for additional details.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer generated randomised schedule 1:1 ratio in randomly varying blocks was prepared by the statistician on the research team (not involved in recruitment)"
Allocation concealment (selection bias) Low risk Quote: "on skin closure, the RNA opened the next sealed, opaque, numbered envelope"
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: "the independent outcome assessors as well as the data analyst were blinded to group allocation"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk An ITT analysis was used.
Selective reporting (reporting bias) Low risk Planned outcomes reported. Protocol pre‐registered on ANZCTR.
Other bias Low risk None detected.