Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06164444

Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention: Reusable drapes and gowns

Other

Reusable drapes and gowns used during surgery.

Comparator: Disposable (single-use) drapes and gowns

Other

Disposable drapes and gowns used during surgery.

Primary outcomes

  1. Surgical site infection (SSI)

    Time frame: 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 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

  5. Readmission to hospital

    Time frame: Within 30 days of surgery

  6. Reoperation for SSI

    Time frame: Within 30 days of surgery

  7. Total length of hospital stay

    Time frame: Within 30 days of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Divya Kapoor

CONTACT

[email protected]

+44 (0)121 415 9103

Rachel Lillywhite

CONTACT

[email protected]

07739743528

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: DRAGON

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.