The Falcon Trial

FALCON: Pragmatic multi-centre factorial randomised controlled trial testing measures to reduce surgical site infection in low and middle income countries

0
Continents
0
Countries
0
Hospitals
0
Patients recruited

FALCON is the first global surgical trial testing measures to reduce Surgical Site Infection (SSI) following abdominal surgery in low and middle-income countries.

Surgical site infection is the most common complication after surgery across the world.  It is the commonest healthcare-associated infection in low and middle-income countries.

Surgical site infection (SSI) causes pain, discomfort, disability and time taken to return to work.  Because of this, the surgical site infection costs to healthcare systems increase significantly creating burden on a personal and a society level.  The increased costs can be a major problem in countries with lower income where patients often may require paying for their own treatment.

FALCON is an investigator-initiated and investigator-led trial. FALCON is funded by the UK National Institute for Health Research (NIHR).

Aims & Objectives

  • Primary Objective

    The primary objective of main RCT is to assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (i) clean-contaminated and (ii) contaminated or dirty abdominal surgery.

  • Secondary Objectives

    1. To assess the impact of the interventions on secondary clinical outcomes up to 30 days post-surgery including: SSI at discharge, mortality, unplanned wound opening, re-operation, length of hospital stay, re-admission, and return to normal activities.
    2. To assess the impact of the interventions on the resistance of organisms isolated from wound swabs to prophylactic antibiotics administered.
    3. To explore the impact of the interventions on service delivery and additional costs to the secondary health service provider.
  • The recruitment target is 5788 participants across all centres.

Collaborating Countries

FALCON is an international trial being conducted in multiple NIHR funded countries. Click on the map below to see participating countries.

Trial Summary

Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work. SSIs increase health costs and this can have a major impact on patients, communities, and providers in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection.

The GlobalSurg-2 cohort study captured data on 12539 patients undergoing abdominal surgery across 343 hospitals in 66 countries, with a primary outcome measure of SSI. The overall SSI rate was 12.3% (1538/12539), which more than doubled across high,