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

Karlakki 2016.

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: 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 total hip or knee arthroplasties (for any indication) with any of 3 consultant surgeons
 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 effectiveness of incisional negative pressure wound therapy dressing (iNPWTd)
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
  • SSI

  • blisters

  • haematoma

  • hospital readmission


Validity of measure/s: not described
Time points: 1, 2, and 6 weeks postsurgery
Notes Investigator contacted for additional details.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the randomisation was performed using sealed opaque envelopes with a block size of 20 shuffled envelopes"
Comment: no sequence generation was required.
Allocation concealment (selection bias) Low risk Quote: "the randomisation was performed using sealed opaque envelopes with a block size of 20 shuffled envelopes"
Comment: allocation was unknown until envelope opened.
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
PP analysis
Comment: more participants were excluded from the analysis in the intervention group (8 intervention vs 3 control).
Selective reporting (reporting bias) Low risk Expected outcomes reported.
Other bias High risk Intervention participants were seen in a wound clinic at 1 week, and control participants were not.