FALCON Trial Testing Measures to Reduce Surgical Site Infection
NCT ID: NCT03700749
Last Updated: 2019-09-26
Study Results
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Basic Information
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UNKNOWN
PHASE3
5480 participants
INTERVENTIONAL
2018-11-29
2021-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
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
TREATMENT
DOUBLE
Study Groups
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2%chlorhexidine + non-coated suture
2%alcoholic chlorhexidine + non-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with non-coated suture for abdominal fascial closure.
2% chlorhexidine + non-coated suture
Interventions:
2% alcoholic chlorhexidine non-coated suture
2%chlorhexidine + coated suture
2%alcoholic chlorhexidine + triclosan-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with triclosan-coated suture for abdominal fascia closure.
2% chlorhexidine + coated suture
Interventions:
2% alcoholic chlorhexidine triclosan coated suture
10% povidone-iodine + non-coated suture
10% povidone-iodine and non-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with non-coated suture for abdominal fascial closure.
10%povidone-iodine + non-coated suture
Interventions:
10% povidone-iodine non-coated suture non-coated suture
10%povidone-iodine + coated suture
10%povidone-iodine/triclosan-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with triclosan-coated suture for abdominal fascial closure.
10%povidone-iodine + coated suture
Interventions:
10% povidone-iodine triclosan coated suture
Interventions
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2% chlorhexidine + non-coated suture
Interventions:
2% alcoholic chlorhexidine non-coated suture
2% chlorhexidine + coated suture
Interventions:
2% alcoholic chlorhexidine triclosan coated suture
10%povidone-iodine + non-coated suture
Interventions:
10% povidone-iodine non-coated suture non-coated suture
10%povidone-iodine + coated suture
Interventions:
10% povidone-iodine triclosan coated suture
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient unable to complete post-operative follow-up (i.e. will not be contactable after discharge).
100 Years
ALL
No
Sponsors
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Lagos State University
OTHER
Universidad Francisco Marroquín
OTHER
Kigali University Teaching Hospital
OTHER
Christian Medical College and Hospital, Ludhiana, India
OTHER
University of Edinburgh
OTHER
University of the Philippines
OTHER
King Edward Medical University
OTHER
University of Witwatersrand, South Africa
OTHER
Universidad Peruana Cayetano Heredia
OTHER
Centre National Hospitalier Universitaire
UNKNOWN
Ndola Teaching Hospital
UNKNOWN
Hospital Espanol de Veracruz
UNKNOWN
Ministry of Health, Ghana
OTHER_GOV
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Dion Morton
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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Lagos University Teaching Hospital
Lagos, , Nigeria
Countries
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Central Contacts
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References
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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.
Other Identifiers
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RG_17-126
Identifier Type: -
Identifier Source: org_study_id
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