Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

University of Birmingham26,800 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

26,800

Conditions

Surgical Site Infection

Interventions

Intervention: Reusable drapes and gownsOTHER

Reusable drapes and gowns used during surgery.

Comparator: Disposable (single-use) drapes and gownsOTHER

Disposable drapes and gowns used during surgery.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

CMNO

Guadalajara, Mexico

RECRUITING

Outcomes

Primary Outcomes

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