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).