Actively Recruiting
Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Led by University of Birmingham · Updated on 2025-02-19
26800
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
C
Christian Medical College, Vellore, India
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on patients undergoing surgery to compare reusable and disposable surgical drapes and gowns in reducing surgical site infections (SSI). It is a large international multi-center study using a cluster randomized design where entire hospitals are assigned to either reusable or disposable products. The purpose is to determine if reusable drapes and gowns are not worse than disposable ones in preventing infections after surgery, considering the potential environmental and cost benefits of reusable materials. The study compares two groups: hospitals using reusable surgical drapes and gowns made from cotton and polyester that are sterilized and reused, and hospitals using disposable drapes and gowns made from non-woven plastic polymers intended for single use. The trial is pragmatic, meaning it reflects real-world hospital practices, and details about sterilization processes or disposable gown types at each hospital will be recorded but not controlled by the study. Hospitals are randomized to use one type of drapes and gowns for their surgeries. Participants are patients aged 10 years and older undergoing surgery with at least one incision meeting size criteria, including emergency or planned surgeries and any operative indication such as caesarean sections. Researchers will monitor surgical site infections within 30 days after surgery as the main outcome, along with secondary outcomes like mortality, wound opening, antibiotic use, emergency visits, readmissions, reoperations, and hospital stay length. The study aims to enroll over 26,000 patients across many hospitals, collecting detailed data to assess infection rates and safety over the first month after surgery.
CONDITIONS
Brief Title
Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 10 years or older
- Have at least one surgical incision 5 cm or longer in adults or 3 cm or longer in children under 16
- Surgical wounds classified as clean-contaminated, contaminated, or dirty
- Undergoing emergency or planned surgery
- Any operative indication including caesarean section
You will not qualify if you...
- Adults with surgical incisions smaller than 5 cm and children under 16 with incisions smaller than 3 cm
- Patients undergoing surgery with only clean surgical wounds
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are assessed to confirm they meet age and surgical wound size criteria before surgery.
Duration - Day of surgery
Participants undergo surgery using either reusable or disposable surgical drapes and gowns as assigned by their hospital.
1 surgery visit (in-person)
Duration - Within 30 days of surgery
Participants are monitored for surgical site infections and other post-operative outcomes.
Follow-up assessments within 30 days after surgery
Trial Site Locations
Total: 1 location
1
CMNO
Guadalajara, Mexico
Actively Recruiting
Research Team
R
Rachel Lillywhite
D
Divya Kapoor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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