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

Nherera 2017.

Methods Study design: randomised controlled trial (economic evaluation based on the Karlakki 2016 RCT)
Study grouping: parallel
Ethics and informed consent: yes
 Follow‐up period: 6 weeks
Sample size estimate: pilot study
ITT analysis: yes number randomised: 220 number analysed: 209
Funding: study funded through a grant from Smith & Nephew, UK, to cover the cost of NPWT dressings and data collection costs. 2 investigators declared they had funding and consultancy fees from Smith & Nephew.
Pre‐registration: no
Participants Location: Oswestry, UK
 Intervention group: n = 110control group: n = 110
Mean age (SD): intervention group = 69 (9.0)control group = 69.2 (9.0)
 Inclusion criteria: patients undergoing THAs or TKAs (for any indication) with 3 consultant surgeons (SLK, NMG, and RDB – authors of this study)
 Exclusion criteria: patients who had known allergies to dressing, were undergoing revision joint surgery, were unwilling to attend additional clinics, and those on warfarin were excluded.
Interventions Aim/s: to evaluate the cost‐effectiveness of incisional NPWT dressing
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
Outcomes
  • cost‐effectiveness

Notes The first 2 authors are employed by Smith & Nephew, UK (manufacturers of the intervention product).
Quality rating using the CHEERS checklist was 85.4%.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the randomisation was performed using sealed opaque envelopes with a block size of 20 shuffled envelopes"
Comment: unclear how the random sequence was generated
Allocation concealment (selection bias) High risk Quote: "the randomisation was performed using sealed opaque envelopes with a block size of 20 shuffled envelopes"
Comment: surgeons knew at the start of the surgery to which group participants had been randomised.
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 Outcome assessors were aware of group allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 7.3% in intervention group and 2.7% in control group based on a PP analysis
Comment: more intervention participants were excluded from the analysis (8 intervention vs 3 control).
Selective reporting (reporting bias) Low risk Stated outcomes were reported.
Other bias Low risk No other biases detected.