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.

Surgical Clinical Trials in India: Underutilized Opportunities

“…In this ongoing COVID-19 pandemic, when most of the clinical work has been reduced to only essential services in majority of surgical units, the role of multicentric studies cannot be over emphasized. Availability of broadband Internet connections and ease of online collaborations have brought the feasibility of multicentric trials to everyone’s doorstep [ 23 ]. An additional advantage of this is the possibility of increasing participation by smaller hospitals from tier 2 and tier 3 cities.…”

Feasibility and diagnostic accuracy of Telephone Administration of an adapted wound heaLing QuestiONnaire for assessment for surgical site infection following abdominal surgery in low and middle-income countries (TALON): protocol for a study within a trial (SWAT)

“…FALCON is a stratified, pragmatic, multi-centre, 2 × 2 factorial trial testing two measures (skin preparation and antimicrobial sutures) to reduce superficial or deep skin infection following abdominal surgery in seven low-and middle-income countries (NCT03700749) [8]. ChEETAh is a cluster randomised trial evaluating whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30 days after abdominal surgery [26].…”

“…This protocol is reported with reference to recommendations from the Global Health Network for qualitative research in LMICs and Consolidated criteria for reporting qualitative research (COREQ) framework [27,28], recommendations for best practices in a mixed-methods adaptation of outcome measures [29], and STARD guidelines for diagnostic test accuracy studies [30]. The protocols for the two host trials are reported elsewhere [8,26]. This SWAT protocol has been pre-registered on the MRC Hubs for Trial Methodology Research Study Within a Trial database [25] (Queen's University Belfast) (SWAT ID:126).…”

“…Reported rates vary, but SSI is particularly prevalent in abdominal and colorectal surgery; as many as one in three patients get an SSI when the operation involves the large bowel [6]. It was highlighted as the key research priority to improve surgical care worldwide in an international prioritisation process [7] and is the focus of several ongoing global randomised trials [8][9][10][11].…”

Antibiotic prophylaxis in a global surgical context

“…1 Depending on the degree of intraoperative contamination, baseline patient risk and other infection control measures, as many as 50% of patients can suffer surgical wound infections within the 30-days after an operation. 2 As a result, SSI has been the focus of several recent global initiatives including randomised controlled trials of health technologies, 3 quality improvement bundle studies, [4][5][6] and prospective cohort studies. 2,7 Regimens of antibiotic prophylaxis are a key component in the SSI prevention pathway.…”