FALCON Trial Testing Measures to Reduce Surgical Site Infection

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.

Conditions

• Abdominal Surgery
• Surgical Site Infection

Interventions

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

Sponsors & Collaborators

• Lagos State University

  collaborator OTHER

• Universidad Francisco Marroquín

  collaborator OTHER

• Kigali University Teaching Hospital

  collaborator OTHER

• Christian Medical College and Hospital, Ludhiana, India

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• University of the Philippines

  collaborator OTHER

• King Edward Medical University

  collaborator OTHER

• University of Witwatersrand, South Africa

  collaborator OTHER

• Universidad Peruana Cayetano Heredia

  collaborator OTHER

• Centre National Hospitalier Universitaire

  collaborator UNKNOWN

• Ndola Teaching Hospital

  collaborator UNKNOWN

• Hospital Espanol de Veracruz

  collaborator UNKNOWN

• Ministry of Health, Ghana

  collaborator OTHER_GOV

• University of Birmingham

  lead OTHER

Principal Investigators

• Dion Morton · University of Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-29

Primary Completion

2021-07-31

Completion

2021-07-31

Countries

• Nigeria

Study Locations