Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Multicentre non-inferiority cluster randomised trial testing Disposable versus Reusable drApes and Gowns for green OperatiNg theatres. A pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
| Condition(s) | Surgical Site Infection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Multicentre non-inferiority cluster randomised trial testing Disposable versus Reusable drApes and Gowns for green OperatiNg theatres. A pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals. |
| Who can participate | Inclusion criteria: * Patients with at least one incision that is ≥5cm in adults and ≥3cm in children aged under 16 years. This can include both open and minimally-invasive surgery providing at least one incision meets this criteria. * Patients with a clean-contaminated, contaminated, or dirty surgical wound. Definitions of contamination are given in Table 2. * Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery. * Any operative indication (including caesarean section). * Patients aged 10 or over. Exclusion criteria * Adults with an incision \<5 cm and incision \<3cm in children aged under 16 years. * Patients undergoing procedures with a clean surgical wound only. |
| Ages | 10 Years |
| Sex | All |
| Lead sponsor | University of Birmingham |
| Locations | Guadalajara, Mexico |
| Start date | 2024-11-12 |
| NCT ID | NCT06164444 |
| Official listing | https://clinicaltrials.gov/study/NCT06164444 |