Surgical Site InfectionDRAGONNCT06164444
Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
A study testing Intervention: Reusable drapes and gowns and Comparator: Disposable (single-use) drapes and gowns in people with Surgical Site Infection, run by University of Birmingham at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Intervention: Reusable drapes and gowns and Comparator: Disposable (single-use) drapes and gowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,800 participants
- Where
- 1 siteMexico
- Study dates
- 12 Nov 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
CMNO
Guadalajara
Irani Duran, +52 1 229 120 4877, duran.irani@heveracruz.mx
Laura Martinez
About this study
Official title: Multicentre Non-inferiority Cluster Randomised Trial Testing 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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- Intervention: Reusable drapes and gowns, Comparator: Disposable (single-use) drapes and gowns
- Keywords
- Surgery, global surgery, SSI, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Reusable drapes and gownsOther
Reusable drapes and gowns used during surgery.
Comparator: Disposable (single-use) drapes and gownsOther
Disposable drapes and gowns used during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Reusable drapes and gowns | Experimental | * Reusable drapes and gowns are made from cotton and polyester and are protective against fluid contamination and, to a certain extent, mechanical stress.
* Reusable drapes and gowns are usually autoclaved and laundered using pressurised steam. This ensures that bacteria and other microorganisms are killed, sterilising the fabric so it is suitable for re-use. In this pragmatic trial, a specific sterilisation protocol is not mandated, but details of the sterilisation processes in place at each hospital will be captured in the Hospital-level Questionnaire before site opening. We may report this in a paper ahead of the main trial publication. Receives: Other: Intervention: Reusable drapes and gowns |
| Comparator: Disposable (single-use) drapes and gowns | Active comparator | * Single-use surgical gowns and drapes are generally made from non-woven plastic polymers that are protective against fluid contamination and, to a certain extent, mechanical stress.
* They are intended for use during a single operation and are then disposed of as biohazard waste for incineration.
* Typically, four drapes are needed for an abdominal operation (two larger and two smaller drapes), although more may be needed for some procedures.
* A range of disposable gowns are available. The choice of disposable gown will be at the hospital PI's discretion and will be captured in the Hospital-level Questionnaire. Receives: Other: Comparator: Disposable (single-use) drapes and gowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days of surgery
Secondary outcomes (7)
Mortality (and likely cause)
Measured: Within 30 days of surgery
Unplanned wound opening
Measured: Within 30 days of surgery
Antibiotic prescribing for SSI
Measured: Within 30 days of surgery
Reattendance at emergency department
Measured: Within 30 days of surgery
Readmission to hospital
Measured: Within 30 days of surgery
Reoperation for SSI
Measured: Within 30 days of surgery
Total length of hospital stay
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start12 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Kigali University Teaching Hospital, Lagos State University, Hospital Español de Mexico, Christian Medical College and Hospital, Ludhiana, India, Centre National Hospitalier Universitaire Hubert Koutoukou MAGA, University for Development Studies, Tamale, Ghana, Chris Hani Baragwanath Academic Hospital
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164444
- Sponsor's protocol ID
- RG_22-181 - Q1085
- Acronym
- DRAGON
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
- ClinicalTrials.gov ID
- NCT06164444
- Acronym / sponsor ID
- DRAGON / RG_22-181 - Q1085
- Conditions
- Surgical Site Infection
- Keywords
- Surgery, global surgery, SSI, surgical site infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26,800 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Kigali University Teaching Hospital, Lagos State University, Hospital Español de Mexico, Christian Medical College and Hospital, Ludhiana, India, Centre National Hospitalier Universitaire Hubert Koutoukou MAGA, University for Development Studies, Tamale, Ghana, Chris Hani Baragwanath Academic Hospital
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Reusable drapes and gowns | Experimental | Other: Intervention: Reusable drapes and gowns* Reusable drapes and gowns are made from cotton and polyester and are protective against fluid contamination and, to a certain extent, mechanical stress. * Reusable drapes and gowns are usually autoclaved and laundered using pressurised steam. This ensures that bacteria and other microorganisms are killed, sterilising the fabric so it is suitable for re-use. In this pragmatic trial, a specific sterilisation protocol is not mandated, but details of the sterilisation processes in place at each hospital will be captured in the Hospital-level Questionnaire before site opening. We may report this in a paper ahead of the main trial publication. |
| Comparator: Disposable (single-use) drapes and gowns | Active comparator | Other: Comparator: Disposable (single-use) drapes and gowns* Single-use surgical gowns and drapes are generally made from non-woven plastic polymers that are protective against fluid contamination and, to a certain extent, mechanical stress. * They are intended for use during a single operation and are then disposed of as biohazard waste for incineration. * Typically, four drapes are needed for an abdominal operation (two larger and two smaller drapes), although more may be needed for some procedures. * A range of disposable gowns are available. The choice of disposable gown will be at the hospital PI's discretion and will be captured in the Hospital-level Questionnaire. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Adults with an incision <5 cm and incision <3cm in children aged under 16 years.
- Patients undergoing procedures with a clean surgical wound only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Reusable drapes and gownsReusable drapes and gowns used during surgery. | Other | Intervention: Reusable drapes and gowns |
| Comparator: Disposable (single-use) drapes and gownsDisposable drapes and gowns used during surgery. | Other | Comparator: Disposable (single-use) drapes and gowns |
Primary outcome
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
7 secondary outcomes
Mortality (and likely cause)
Time frame: Within 30 days of surgery
Unplanned wound opening
Time frame: Within 30 days of surgery
Antibiotic prescribing for SSI
Time frame: Within 30 days of surgery
Reattendance at emergency department
Time frame: Within 30 days of surgery
Readmission to hospital
Time frame: Within 30 days of surgery
Reoperation for SSI
Time frame: Within 30 days of surgery
Total length of hospital stay
Time frame: Within 30 days of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No. Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aneel Bhangu principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Reusable drapes and gowns and Comparator: Disposable (single-use) drapes and gowns in people with Surgical Site Infection, run by University of Birmingham at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lillywhite (07739743528, r.e.lillywhite@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (SSI) (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.