Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

Not Applicable

Recruiting

• Conditions: Surgical Site Infection

• Registration Number: NCT06164444
• Lead Sponsor: University of Birmingham

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.

Study Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Study Start: 2024-11-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Readmission to hospital	Within 30 days of surgery
Total length of hospital stay	Within 30 days of surgery
Mortality (and likely cause)	Within 30 days of surgery
Reoperation for SSI	Within 30 days of surgery
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

Trial Locations

Locations (1)

CMNO; 🇲🇽 Guadalajara, Mexico