Clinical trial NCT06164444: Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Official title: Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Keywords: Surgery
global surgery
SSI
surgical site infection
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Christian Medical College, Vellore, India
name: Kigali University Teaching Hospital
name: Lagos State University
name: Hospital Español de Mexico
name: Christian Medical College and Hospital, Ludhiana, India
name: Centre National Hospitalier Universitaire Hubert Koutoukou MAGA
name: University for Development Studies, Tamale, Ghana
name: Chris Hani Baragwanath Academic Hospital
First posted: 2023-12-11
Enrollment: 26800
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
Primary purpose: OTHER

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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infection (SSI)
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Mortality (and likely cause)
timeFrame: Within 30 days of surgery
measure: Unplanned wound opening
timeFrame: Within 30 days of surgery
measure: Antibiotic prescribing for SSI
timeFrame: Within 30 days of surgery
measure: Reattendance at emergency department
timeFrame: Within 30 days of surgery
measure: Readmission to hospital
timeFrame: Within 30 days of surgery
measure: Reoperation for SSI
timeFrame: Within 30 days of surgery
measure: Total length of hospital stay
timeFrame: Within 30 days of surgery
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: CMNO
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
References: