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 |
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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 |
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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 |
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Outcomes |
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 |
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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. |