Overview

FALCON Trial Testing Measures to Reduce Surgical Site Infection

Status:
Unknown status
Trial end date:
2021-07-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Birmingham
Collaborators:
Centre National Hospitalier Universitaire
Christian Medical College and Hospital, Ludhiana, India
Hospital Espanol de Veracruz
Kigali University Teaching Hospital
King Edward Medical University
Lagos State University
Ndola Teaching Hospital
Tamale Teaching Hospital, Tamale
Universidad Francisco Marroquín
Universidad Peruana Cayetano Heredia
University of Edinburgh
University of the Philippines
University of Witwatersrand, South Africa
Treatments:
Cadexomer iodine
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone
Povidone-Iodine
Triclosan
Criteria
Inclusion Criteria:

- Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic
extraction site), with an anticipated clean-contaminated, contaminated or dirty
surgical wound.

- Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery
on a planned admission) operations.

- Any operative indication, including trauma surgery.

- Patient able and willing to provide written informed consent (signature or a
fingerprint).

- Paediatric and adult patients. This criteria is made country-specific. Each country
decides the lower age limit for the trial. This is dependent on country-specific
regulatory approvals. Age eligibility will vary by country.

Exclusion Criteria:

- Patients with a documented or suspected allergy to iodine, shellfish, or chlorhexidine
skin preparation solution.

- Patient unable to complete post-operative follow-up (i.e. will not be contactable
after discharge).