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 |
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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. |
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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 |
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Outcomes |
Validity of measure/s: not described Time points: 1, 2, 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: "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. |