Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres

Study Overview
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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.

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. Eligibility: Clusters: Hospitals where there is clinical and organisational equipoise to randomise between disposable and reusable drapes and gowns. Participants: Patients (adults and children) undergoing surgery with incision of at least ≥5cm in adults and ≥3cm in children aged under 16 years, with a clean-contaminated or contaminated/dirty wound. Participants undergoing emergency or elective, and open or minimally invasive surgery are eligible. 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.

Official Title
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Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Other: Intervention: Reusable drapes and gowns
* Other: Comparator: Disposable (single-use) drapes and gowns


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Reusable drapes and gowns<br>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. | Other: Intervention: Reusable drapes and gowns<br>* Reusable drapes and gowns used during surgery.<br>|
| Active Comparator: Comparator: Disposable (single-use) drapes and gowns<br>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. | Other: Comparator: Disposable (single-use) drapes and gowns<br>* Disposable drapes and gowns used during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection (SSI) | SSI according to centre for disease control (CDC) criteria: The infection must occur within 30-days of the index operation AND The infection must involve the skin, subcutaneous, muscular, or fascial layers of the incision AND The patient must have at least one of the following: Purulent drainage from the wound Organisms are detected from a wound swab Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of pain or tenderness; localised swelling; redness; heat; systemic fever (>38°C). Diagnosis of SSI by a clinician or on imaging | Within 30 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality (and likely cause) |  | Within 30 days of surgery | 
| Unplanned wound opening |  | Within 30 days of surgery | 
| Antibiotic prescribing for SSI |  | Within 30 days of surgery | 
| Reattendance at emergency department |  | Within 30 days of surgery | 
| Readmission to hospital |  | Within 30 days of surgery | 
| Reoperation for SSI |  | Within 30 days of surgery | 
| Total length of hospital stay |  | Within 30 days of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, global surgery, SSI, surgical site infection