Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres

Surgical Site Infection Clinical Trial

— DRAGON  

Official title:

Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164444
• Other study ID #: RG_22-181 - Q1085
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: University of Birmingham
• Contact: Rachel Lillywhite
• Phone: 07739743528
• Email: r.e.lillywhite[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26800
• Est. completion date: July 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Intervention: Reusable drapes and gowns
Reusable drapes and gowns used during surgery.
• Comparator: Disposable (single-use) drapes and gowns
Disposable drapes and gowns used during surgery.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University of Birmingham	Centre National Hospitalier Universitaire Hubert Koutoukou MAGA, Chris Hani Baragwanath Academic Hospital, Christian Medical College and Hospital, Ludhiana, India, Christian Medical College, Vellore, India, Hospital Español de Mexico, Kigali University Teaching Hospital, Lagos State University, University for Development Studies, Tamale, Ghana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days of surgery
Secondary	Mortality (and likely cause)		Within 30 days of surgery
Secondary	Unplanned wound opening		Within 30 days of surgery
Secondary	Antibiotic prescribing for SSI		Within 30 days of surgery
Secondary	Reattendance at emergency department		Within 30 days of surgery
Secondary	Readmission to hospital		Within 30 days of surgery
Secondary	Reoperation for SSI		Within 30 days of surgery
Secondary	Total length of hospital stay		Within 30 days of surgery