Skip to main content
. 2019 Mar 26;2019(3):CD009261. doi: 10.1002/14651858.CD009261.pub4

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
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
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
Outcomes
  • SSI

  • blisters

  • cost

  • QoL


Validity of measure/s: no
Time points: 10 to 12 days postsurgery
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.