Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

NCT06164444 | Recruiting DMC

• 1 other identifier: RG_22-181 - Q1085
• Study Type: interventional
• Target: 26,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infection

Keywords

Surgery; global surgery; SSI; surgical site infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Intervention: Reusable drapes and gowns

EXPERIMENTAL

* 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

Comparator: Disposable (single-use) drapes and gowns

ACTIVE COMPARATOR

* 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

Interventions

Intervention: Reusable drapes and gowns OTHER

Reusable drapes and gowns used during surgery.

Intervention: Reusable drapes and gowns

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

Disposable drapes and gowns used during surgery.

Comparator: Disposable (single-use) drapes and gowns

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Adults with an incision \<5 cm and incision \<3cm in children aged under 16 years.
• Patients undergoing procedures with a clean surgical wound only.

Sponsors & Collaborators

• University of Birmingham: lead
• Christian Medical College, Vellore, India: collaborator
• Kigali University Teaching Hospital: collaborator
• Lagos State University: collaborator
• Hospital Español de Mexico: collaborator
• Christian Medical College and Hospital, Ludhiana, India: collaborator
• Centre National Hospitalier Universitaire Hubert Koutoukou MAGA: collaborator
• University for Development Studies, Tamale, Ghana: collaborator
• Chris Hani Baragwanath Academic Hospital: collaborator

Study Sites (1)

CMNO

Guadalajara, Mexico

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aneel Bhangu

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lillywhite

CONTACT

07739743528; r.e.lillywhite@bham.ac.uk

Divya Kapoor

CONTACT

+44 (0)121 415 9103; d.kapoor@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: November 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)