Comparing disposable and reusable surgical drapes and gowns to reduce infections
Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
NA · University of Birmingham · NCT06164444
This study is testing if reusable surgical drapes and gowns can help prevent infections just as well as disposable ones for patients having surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 26800 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | University of Birmingham (other) |
| Locations | 1 site (Guadalajara) |
| Trial ID | NCT06164444 on ClinicalTrials.gov |
What this trial studies
This multicentre non-inferiority trial aims to evaluate the effectiveness of reusable surgical drapes and gowns compared to disposable ones in preventing surgical site infections (SSIs) during surgeries. Conducted across multiple hospitals internationally, the study will involve a total of 26,800 participants, with each hospital acting as a cluster. The trial will assess whether the reusable options are non-inferior in reducing SSIs, which is crucial given the financial and environmental implications of disposable products. The study will include patients undergoing various types of surgeries with specific incision criteria.
Who should consider this trial
Good fit: Ideal candidates include patients aged 10 and over undergoing surgeries with incisions of at least 5 cm for adults and 3 cm for children.
Not a fit: Patients with smaller incisions or those undergoing procedures with clean surgical wounds only may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more sustainable and cost-effective approach to surgical procedures without compromising patient safety.
How similar studies have performed: Previous studies have not definitively established the superiority of either disposable or reusable surgical drapes, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. * Patients with a clean-contaminated, contaminated, or dirty surgical wound. Definitions of contamination are given in Table 2. * Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery. * Any operative indication (including caesarean section). * Patients aged 10 or over. Exclusion criteria * Adults with an incision \<5 cm and incision \<3cm in children aged under 16 years. * Patients undergoing procedures with a clean surgical wound only.
Where this trial is running
Guadalajara
- CMNO — Guadalajara, Mexico (RECRUITING)
Study contacts
- Principal investigator: Aneel Bhangu — University of Birmingham
- Study coordinator: Rachel Lillywhite
- Email: r.e.lillywhite@bham.ac.uk
- Phone: 07739743528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infection, Surgery, global surgery, SSI, surgical site infection