Manoharan 2016.
Methods |
Study design: randomised controlled trial Study grouping: bilateral knees were randomised to intervention or control knees Ethics and informed consent: yes Sample size estimate: yes, but sample did not reach target, stopped due to financial constraints Follow‐up period: 10 days ITT analysis: yes number randomised: 21 number analysed: 21 Funding: KCI, Acelity Inc provided the negative pressure wound therapy dressings for the study. Pre‐registration: retrospectively registered as ANZCTR 12615001350516 |
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Participants |
Location: Queensland, Australia
Intervention group: n = 21 kneescontrol group: n = 21 knees Mean age (range): 66 (45 to 80) Inclusion criteria: patients undergoing a bilateral knee arthroplasty Exclusion criteria: aged < 18 years or pregnant |
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Interventions |
Aim/s: to assess the effect of NPWT on outcomes after primary arthroplasty Group 1 (NPWT) intervention: the intervention group received PREVENA Incision Management System, Acelity, KCI, which was placed over the closed surgical incision under sterile conditions at the end of the procedure. The NPWT device provided a continuous negative pressure of 125 mmHg for a duration of 8 days. Group 2 (control) intervention: the conventional dry dressing was placed over the closed surgical incision under sterile conditions at the end of the procedure. Neither the type of control dressing nor when the dressing was removed was reported. Study date/s: February to December 2014 |
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Outcomes |
Validity of measure/s: no Time points: 10 to 12 days 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 | Simple randomisation was performed by the research assistants via online computer software that indicated the side to which the intervention, NPWT, would be applied. |
Allocation concealment (selection bias) | High risk | The surgeons were notified on the day of surgery, before the commencement of the procedure. It was also unclear if consecutive patients for each of the 3 surgeons were recruited. |
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 | The final incision assessment was performed by the surgeon and clinic nurse and witnessed by 1 of the research assistants. There were no independent observers attached to this assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It was unclear if all participants were accounted for in the results as the numbers analysed for each outcome are not stated. |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported. Protocol retrospectively registered as ANZCTR 12615001350516. |
Other bias | Low risk | No other biases detected. |