Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention: Reusable drapes and gowns

    Other intervention

    Reusable drapes and gowns used during surgery.

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

    Other intervention

    Disposable drapes and gowns used during surgery.

Treatment groups

26,800 Participants
are divided into 2 treatment groups
Group A: Intervention: Reusable drapes and gownsExperimental treatment 1 intervention
Group B: Comparator: Disposable (single-use) drapes and gownsActive comparator 1 intervention

Trial outcomes

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

Time frame
Within 30 days of surgery

Secondary outcomes

1

Mortality (and likely cause)

Time frame
Within 30 days of surgery
2

Unplanned wound opening

Time frame
Within 30 days of surgery
3

Antibiotic prescribing for SSI

Time frame
Within 30 days of surgery
4

Reattendance at emergency department

Time frame
Within 30 days of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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