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

Abstract

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.

Keywords: randomized controlled trial; surgery; surgical site infection; wound infection.