NCT03700749

FALCON Trial Testing Measures to Reduce Surgical Site Infection

Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,480 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure: A. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and non-coated suture for wound closure; B. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and triclosan coated suture for wound closure; C. In this arm surgeon will use for operation 10% aqueous povidone-iodine for skin cleansing and non-coated suture for wound closure; D. In this arm surgeon will use 10% aqueous povidone-iodine for skin cleansing and triclosan-coated suture.

Detailed description

FALCON is a pragmatic, blinded (patient and outcome assessor), 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce Surgical Site Infection (SSI) rates in patients undergoing surgery with an abdominal incision. 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 (3). SSIs increase healthcare costs in all health settings. Whilst there is no direct data on the costs of SSI in LMICs, within the UK National Health Service, SSIs cost approximately £3500 per patient and £700 million per year in total. The impact of increased healthcare costs on patients, communities, and providers can be major 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 hospital acquired infection. Strata in FALCON trial are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between: A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture. Participant will be recruited from hospitals in Low and Middle Income Countries (LMICs). Participants who is undergoing abdominal surgery with an anticipated clean-contaminated, contaminated or dirty surgical wound will be selected to enter the trial. The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main RCT will recruit 5480 participants.

Conditions

• Abdominal Surgery
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	2% chlorhexidine + non-coated suture	Interventions: 2% alcoholic chlorhexidine non-coated suture
DRUG	2% chlorhexidine + coated suture	Interventions: 2% alcoholic chlorhexidine triclosan coated suture
DRUG	10%povidone-iodine + non-coated suture	Interventions: 10% povidone-iodine non-coated suture non-coated suture
DRUG	10%povidone-iodine + coated suture	Interventions: 10% povidone-iodine triclosan coated suture

Timeline

• Start date: 2018-11-29
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2018-10-09
• Last updated: 2019-09-26

Locations

1 site across 1 country: Nigeria