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 |
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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 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. |
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| 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 |
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| Outcomes |
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| 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%. |
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| 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. |