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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Other: Intervention: Reusable drapes and gowns; Other: Comparator: Disposable (single-use) drapes and gowns

Detailed 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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 26800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Lillywhite; Phone Number: 07739743528; Email: r.e.lillywhite@bham.ac.uk
• Study Contact Backup: Name: Divya Kapoor; Phone Number: +44 (0)121 415 9103; Email: d.kapoor@bham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Christian Medical College and Hospital, Ludhiana, India; Lagos State University; Christian Medical College, Vellore, India; Kigali University Teaching Hospital; Chris Hani Baragwanath Academic Hospital; University for Development Studies, Tamale, Ghana; Hospital Español de Mexico; Centre National Hospitalier Universitaire Hubert Koutoukou MAGA
• Investigators: Principal Investigator: Aneel Bhangu, University of Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; global surgery; surgical site infection; SSI
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: RG_22-181 - Q1085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No