| Sumario: | <p><strong>Aims</strong></p>
<p>This study sought to provide estimates for the different rates of deep surgical site infection as measured by the Centres for Disease Control definition after hip fracture surgery between patients treated with either incisional Negative Pressure Wound Therapy (NPWT) or standard wound dressings. Secondary objectives included determining recruitment rate and willingness to participate in the trial.</p>
<p><strong>Patients and Methods</strong></p>
<p>A two group multicentre randomised controlled feasibility trial embedded in the World Hip Trauma Evaluation cohort study. Any patient over the age of 65 years having surgery for hip fracture was considered at 5 recruitment centres in the United Kingdom. Patients were randomly allocated to either incisional NPWT or standard dressings after closure of the surgical wound.
The primary outcome measure was deep Surgical Site Infection at 30 and 90 days diagnosed according to the criteria of the Centers for Disease Control and Prevention. Secondary outcomes were: rate of recruitment, further surgery within 120 days, health-related quality of life (HRQOL) measured using the EQ5D-5L tool and related complications within 120 days as well as mobility and residential status at 120 days.</p>
<p><strong>Results</strong></p>
<p>462 valid randomisations were carried out (232 and 230 respectively in the incisional NPWT and standard dressing groups). In the standard dressing group, 14 patients developed deep SSI out of 218 analysed (6.4%). In the incisional NPWT group 4 patients developed deep SSI out of 214 analysed (1.9%). This gives a total SSI event rate of 4.2% (95% CI 2.7%-6.5%). Patients and surgeons were willing to participate in this study with 462 patients recruited from a possible 749 cases (62.3%).</p>
<p><strong>Conclusions </strong></p>
<p>The estimated rate of deep surgical site infection 30 days after hip fracture surgery was 4%, which makes a study comparing the clinical effectiveness of incisional NPWT to standard dressings feasible. </p>
Ethics and dissemination Oxford C Research Ethics Committee granted ethical approval on 28/04/2017, 17/ SC/0207. ISRCTN55305726.
|
|---|