Reducing surgical site infections in low-income and middle-income countries (FALCON): A pragmatic, multicenter stratified, randomized controlled trial
The Lancet Nov 10, 2021
Ademuyiwa AO, Hardy P, Runigamugabo E, et al. - For prevention of surgical site infection (SSI), WHO guidelines recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures. Researchers sought to test both these interventions in low-income and middle-income countries.
FALCON, a 2 × 2 factorial, randomized controlled trial, was conducted; stratification was done by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater.
Randomization of a total of 5,788 patients (3,091 in clean-contaminated stratum, 2,697 in contaminated or dirty stratum) was done (1,446 to alcoholic chlorhexidine and non-coated suture, 1,446 to alcoholic chlorhexidine and triclosan-coated suture, 1,447 to aqueous povidone–iodine and non-coated suture, and 1,449 to aqueous povidone–iodine and triclosan-coated suture).
Benefits did not appear in correlation with 2% alcoholic chlorhexidine skin preparation vs povidone–iodine, or with triclosan-coated sutures vs non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds.
Relative to the alternatives, the two interventions are more expensive, and are not recommended for routine use.
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