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Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres — DRAGON  

Surgical Site Infection Clinical Trial

Official title:
Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06164444
Study type Interventional
Source University of Birmingham
Contact Rachel Lillywhite
Phone 07739743528
Email r.e.lillywhite@bham.ac.uk
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date July 31, 2026
View Details
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