Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres (DRAGON)

University of Birmingham

Status: Enrolling

Conditions: Surgical Site Infection

Treatments: Other: Comparator: Disposable (single-use) drapes and gowns; Other: Intervention: Reusable drapes and gowns

Study type: Interventional

Funder types: Other

Identifiers

NCT06164444

RG_22-181 - Q1085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26,800 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26,800 participants in 2 patient groups

Intervention: Reusable drapes and gowns

Experimental group

Description:

* Reusable drapes and gowns are made from cotton and polyester and are protective against fluid contamination and, to a certain extent, mechanical stress. * Reusable drapes and gowns are usually autoclaved and laundered using pressurised steam. This ensures that bacteria and other microorganisms are killed, sterilising the fabric so it is suitable for re-use. In this pragmatic trial, a specific sterilisation protocol is not mandated, but details of the sterilisation processes in place at each hospital will be captured in the Hospital-level Questionnaire before site opening. We may report this in a paper ahead of the main trial publication.

Treatment:

Other: Intervention: Reusable drapes and gowns

Comparator: Disposable (single-use) drapes and gowns

Active Comparator group

Description:

* Single-use surgical gowns and drapes are generally made from non-woven plastic polymers that are protective against fluid contamination and, to a certain extent, mechanical stress. * They are intended for use during a single operation and are then disposed of as biohazard waste for incineration. * Typically, four drapes are needed for an abdominal operation (two larger and two smaller drapes), although more may be needed for some procedures. * A range of disposable gowns are available. The choice of disposable gown will be at the hospital PI's discretion and will be captured in the Hospital-level Questionnaire.

Treatment:

Other: Comparator: Disposable (single-use) drapes and gowns