Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
ConditionSurgical Site Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Adults with an incision <5 cm and incision <3cm in children aged under 16 years.
Patients undergoing procedures with a clean surgical wound only.
Trial design
Treatments tested in this trial
- Intervention: Reusable drapes and gowns
- Comparator: Disposable (single-use) drapes and gowns
Treatment groups
26,800 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Birmingham
Lead sponsor
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
Source ClinicalTrials.gov