Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

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 likely to have higher financial and carbon costs, they are only justifiable if they can be proven to significantly reduce surgical site infections (SSIs).

Aim: This randomised controlled trial will assess whether reusable surgical drapes and gowns are non-inferior in reducing SSI compared to disposable drapes and gowns in patients undergoing surgery.

Design: Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.

Intervention: Reusable surgical drapes and gowns.

Comparator: Disposable (single-use) surgical drapes and gowns.

Sample size: The control group SSI event rate is estimated to be 12.5% based on previous literature. To determine whether reusable drapes and gowns are non-inferior to disposable drapes and gowns with a non-inferiority margin of 2.5% would require a total of 26,800 participants from 134 clusters, with an average of 200 participants per cluster, assuming 90% power, 2.5% one-sided alpha, intraclass correlation of 0.01 and 5% participant loss to follow up.

• Mortality (and likely cause) [Срок оценки: Within 30 days of surgery]
• Unplanned wound opening [Срок оценки: Within 30 days of surgery]
• Antibiotic prescribing for SSI [Срок оценки: Within 30 days of surgery]
• Reattendance at emergency department [Срок оценки: Within 30 days of surgery]
• Readmission to hospital [Срок оценки: Within 30 days of surgery]
• Reoperation for SSI [Срок оценки: Within 30 days of surgery]
• Total length of hospital stay [Срок оценки: Within 30 days of surgery]