Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intervention: Reusable drapes and gowns

* 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.

Group Type EXPERIMENTAL

Intervention: Reusable drapes and gowns

Intervention Type OTHER

Reusable drapes and gowns used during surgery.

Comparator: Disposable (single-use) drapes and gowns

* 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.

Group Type ACTIVE_COMPARATOR

Comparator: Disposable (single-use) drapes and gowns

Intervention Type OTHER

Disposable drapes and gowns used during surgery.

Interventions

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Intervention: Reusable drapes and gowns

Reusable drapes and gowns used during surgery.

Intervention Type OTHER

Comparator: Disposable (single-use) drapes and gowns

Disposable drapes and gowns used during surgery.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No