University of Birmingham
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.
Surgical Site Infection
Intervention: Reusable drapes and gowns
Comparator: Disposable (single-use) drapes and gowns
NA
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 26800 participants |
| Masking : | SINGLE |
| Masking Description : | Patients will not specifically be blinded to the treatment allocation and those operated under non-general anaesthesia are likely to see the drapes and gowns used. However, most patients are unlikely to be able to recognise and differentiate between the different types of reusable and single use gowns and drapes, meaning unblinded patients are a low risk of bias. As this is a cluster randomised trial, outcome assessors are likely to know the hospital allocation and are therefore unlikely to be blinded. Assessors will receive formal training to undertake patient record review, in-person wound assessment, or telephone follow-up, as appropriate for their site. Assessors will collect detailed wound-related variables. The primary outcome of SSI will be determined by a computer-based algorithm based on the CDC criteria, using this data. |
| Primary Purpose : | OTHER |
| Official Title : | Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres |
| Actual Study Start Date : | 2024-11-12 |
| Estimated Primary Completion Date : | 2026-06-30 |
| Estimated Study Completion Date : | 2026-07-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 10 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
CMNO
Guadalajara, Mexico,