Status:
RECRUITING
Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Christian Medical College, Vellore, India
Kigali University Teaching Hospital
Conditions:
Surgical Site Infection
Eligibility:
All Genders
10+ years
Phase:
NA
Brief 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 cluste...
Detailed Description
Background: The World Health Organisation makes no recommendation for the use of disposable or reusable surgical drapes and gowns due to a lack of effectiveness evidence. Since disposable versions are...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
26800 Patients enrolled
Trial Details
Trial ID
NCT06164444
Start Date
November 12 2024
End Date
July 31 2026
Last Update
February 19 2025
Active Locations (1)
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1
CMNO
Guadalajara, Mexico