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.
Timeline
- Start
- 2018-11-29
- Primary completion
- 2021-07-31
- Completion
- 2021-07-31
Publications
- NIHR Global Health Research Unit on Global Surgery. Mechanisms and causes of death after abdominal surgery in low-income and middle-income countries: a secondary analysis of the FALCON trial. Lancet Glob Health. 2024 Nov;12(11):e1807-e1815. doi: 10.1016/S2214-109X(24)00318-8. Epub 2024 Sep 5.
- NIHR Global Health Research Unit on Global Surgery. Accuracy of the Wound Healing Questionnaire in the diagnosis of surgical-site infection after abdominal surgery in low- and middle-income countries. Br J Surg. 2024 Jan 31;111(2):znad446. doi: 10.1093/bjs/znad446.
- Monahan M, Glasbey J, Roberts TE, Jowett S, Pinkney T, Bhangu A, Morton DG, de la Medina AR, Ghosh D, Ademuyiwa AO, Ntirenganya F, Tabiri S; NIHR Global Research Health Unit on Global Surgery. The costs of surgical site infection after abdominal surgery in middle-income countries: Key resource use In Wound Infection (KIWI) study. J Hosp Infect. 2023 Jun;136:38-44. doi: 10.1016/j.jhin.2023.03.023. Epub 2023 Apr 21.
- NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries. Lancet. 2022 Nov 19;400(10365):1767-1776. doi: 10.1016/S0140-6736(22)01884-0. Epub 2022 Oct 31.
- NIHR Global Research Health Unit on Global Surgery. Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial. Lancet. 2021 Nov 6;398(10312):1687-1699. doi: 10.1016/S0140-6736(21)01548-8. Epub 2021 Oct 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorhexidine | Small molecule | 2 % | — |
| Comparator | Povidone-Iodine | Other / unclassified | 10 % | — |
| Comparator | Triclosan | Small molecule | — | — |
Indications
No indication recorded.