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FALCON Trial Testing Measures To Reduce Surgical Site Infections

Pragmatic multicentre factorial randomised controlled trial testing measures to reduce surgical site infection in low and middle income countries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018388
Enrollment
5480
Registered
2019-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 2% Alcoholic Chlorhexidine,: Surgical Pre-Operative Skin Preparation. 2% Alcoholic Chlorhexidine will be used in the usual standardised technique. The preparation will be applied on the

Sponsors

University OF Birmingham
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with at least one abdominal incision that is equal to or greater than five cms with an anticipated clean contaminated, contaminated or dirty surgical wound Patients undergoing emergency or elective operations Any operative indication including trauma surgery Patient willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: Patients with documented or suspected allergy to iodine, shellfish or chlorhexidine skin preparation solution Patient unable to complete post operative follow up

Design outcomes

Primary

MeasureTime frame
Surgical site infection at thirty days post surgeryTimepoint: Surgical site infection at thirty days post surgery

Secondary

MeasureTime frame
Length of hospital stay for index admissionTimepoint: Discharge date;Mortality within 30 days post surgeryTimepoint: 30 days;Re operation for surgical site infectionsTimepoint: 30 days;ReadmissionTimepoint: 30 Days;Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within one hour of incisionTimepoint: 1 hour;Return to normal activitiesTimepoint: 30 Days;Surgical site infection at discharge from hospitalTimepoint: Discharge;Unplanned wound opening within 30 days of surgeryTimepoint: 30 days

Countries

Benin, Egypt, Ghana, Guatemala, India, Mexico, Nigeria, Pakistan, Peru, Philippines, Rwanda, South Africa, Zambia

Contacts

Public ContactDhruva Nath Ghosh

Christian Medical College & Hospital Ludhiana, Punjab

dhruvghosh73@gmail.com9915198894

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026