DRAGON: a cluster RCT of reusable versus single-use drapes and gowns in NHS operating theatres
Patients (adults) undergoing elective or emergency surgery with at least one incision ≥5 cm in adults and a clean-contaminated, contaminated or dirty wound, in NHS hospitals where there is equipoise to use either disposable or reusable drapes and gowns.
Intervention: Reusable drapes and gowns Comparator: Disposable (single-use) drapes and gowns This study is designed as a pragmatic, multicentre cluster-randomised controlled trial of reusable versus disposable drapes and gowns to quickly provide evidence. Clusters will be randomly allocated to reusable drapes and gowns (intervention group) or disposable drapes and gowns (control group). Within a hospital, multiple theatres can be randomised in parallel, only if each is acting as its own cluster and includes consecutive patients separately. New theatres cannot join an already randomised theatre, as the new theatre will not be blind to allocation. Hospital sites will be informed of their random allocation before any patients are assessed for eligibility. Theatres that have completed their participation in DRAGON are then eligible for re-randomisation if they wish. A cluster randomised design is the most appropriate design to minimise the risk of contamination in the control arm of the trial. Once theatre staff are trained to implement the intervention (of using reusable drapes and gowns), it is likely to become routine practice, making individual randomisation unfeasible. To produce generalisable evidence, common operations will be included from across our network, as well as including children. The FALCON, CHEETAH, and ROSSINI networks are established collaborations focusing on abdominal surgery. A simple design was chosen to ensure that the trial is delivered in a timely way, as the design can be rapidly approved and opened across this network. Clusters can take part where there is clinical and organisational equipoise to randomise between disposable and reusable drapes and gowns. The theatres taking part within a cluster will be formed differently at different hospitals, as every hospital around the world is different. It may include selected theatres within a hospital or selected surgical teams who use various theatres, in each case where equipoise exists and
1. 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. 2. Patients with a clean-contaminated, contaminated, or dirty surgical wound. 3. Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery. 4. Any operative indication (including caesarean section). 5. Patients aged 5 years and over.
1. Adults with an incision <5 cm and incision <3cm in children aged under 16 years. 2. Patients undergoing procedures with a clean surgical wound only.