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 |
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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 |
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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 |
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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 (QoL reported in the Heard 2017 study). Time points: 30 days and 6 weeks postsurgery |
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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. |