Surgical Site Infection
Conditions
Keywords
Surgery, global surgery, SSI, surgical site infection
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.
Interventions
OTHERIntervention: Reusable drapes and gowns
Reusable drapes and gowns used during surgery.
OTHERComparator: Disposable (single-use) drapes and gowns
Disposable drapes and gowns used during surgery.
Sponsors
Christian Medical College, Vellore, India
Kigali University Teaching Hospital
Lagos State University
Hospital Español de Mexico
Christian Medical College and Hospital, Ludhiana, India
Centre National Hospitalier Universitaire Hubert Koutoukou MAGA
University for Development Studies, Tamale, Ghana
Chris Hani Baragwanath Academic Hospital
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection (SSI) | Within 30 days of surgery | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mortality (and likely cause) | Within 30 days of surgery |
| Reoperation for SSI | Within 30 days of surgery |
| Total length of hospital stay | Within 30 days of surgery |
| Readmission to hospital | Within 30 days of surgery |
Countries
Mexico
Contacts
Primary ContactRachel Lillywhite
Backup ContactDivya Kapoor
Outcome results
None listed