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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial
Colorectal Disease, Volume 23, No. 1, Year 2021
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Description
Aim: Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs. Method: FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Patients with predicted clean-contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone–iodine and noncoated suture and (4) 10% aqueous povidone–iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI. Conclusion: FALCON will deliver high-quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings. © 2020 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland
Authors & Co-Authors
Ademuyiwa, Adesoji O.
United Kingdom, Birmingham
University of Birmingham
Ghosh, Dhruva Nath
United Kingdom, Birmingham
University of Birmingham
de la Medina, Antonio Ramos
United Kingdom, Birmingham
University of Birmingham
Moore, Rachel L.
United Kingdom, Birmingham
University of Birmingham
Ntirenganya, Faustin
United Kingdom, Birmingham
University of Birmingham
Tabiri, Stephen
United Kingdom, Birmingham
University of Birmingham
Glasbey, James C.
United Kingdom, Birmingham
University of Birmingham
Magill, Laura
United Kingdom, Birmingham
University of Birmingham
Monahan, Mark
United Kingdom, Birmingham
University of Birmingham
Omar, Omar Mohammed
United Kingdom, Birmingham
University of Birmingham
Hardy, Pollyanna
United Kingdom, Birmingham
University of Birmingham
Brocklehurst, Peter S.
United Kingdom, Birmingham
University of Birmingham
Dion G. Morton, Dion Gregory M.
United Kingdom, Birmingham
University of Birmingham
Bhangu, Aneel Amir
United Kingdom, Birmingham
University of Birmingham
Runigamugabo, Emmy
United Kingdom, Birmingham
University of Birmingham
Verjee, Azmina
United Kingdom, Birmingham
University of Birmingham
Adisa, Adewale O.
United Kingdom, Birmingham
University of Birmingham
Aguilera, Maria Lorena
United Kingdom, Birmingham
University of Birmingham
Alexander, Philip Vareed
United Kingdom, Birmingham
University of Birmingham
Harrison, Ewen Munro
United Kingdom, Birmingham
University of Birmingham
Ismail, Lawani
United Kingdom, Birmingham
University of Birmingham
Salem, Hosni K.
United Kingdom, Birmingham
University of Birmingham
Lissauer, David M.
United Kingdom, Birmingham
University of Birmingham
Makupe, Alex M.
United Kingdom, Birmingham
University of Birmingham
Pinkney, Thomas D.
United Kingdom, Birmingham
University of Birmingham
Qureshi, Ahmad Uzair
United Kingdom, Birmingham
University of Birmingham
Roberts, Tracy Elizabeth
United Kingdom, Birmingham
University of Birmingham
Statistics
Citations: 11
Authors: 27
Affiliations: 1
Identifiers
Doi:
10.1111/codi.15354
ISSN:
14628910
Research Areas
Health System And Policy
Study Approach
Quantitative