NCT06164444

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26,800 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
OTHER	Intervention: Reusable drapes and gowns	Reusable drapes and gowns used during surgery.
OTHER	Comparator: Disposable (single-use) drapes and gowns	Disposable drapes and gowns used during surgery.

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-06-30
• Completion: 2026-07-31
• First posted: 2023-12-11
• Last updated: 2025-02-19

Locations

1 site across 1 country: Mexico