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Table 2 IMPs in the COSMO-PD trial

From: Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol

InterventionChlorhexidine gluconateMupirocin ointmentUsual care with normal saline dressing
Description of IMPsNon-ionized cloth impregnated with 2% chlorhexidine gluconate (Ion PAD PLUS CHG2®, Pose Health Care., Ltd.)2% mupirocin calcium ointment (Charoon Bhesaj Co., Ltd.)Isotonic solution, 0.9% sodium chloride irrigation USP (A.N.B. Laboratories Co., Ltd.)
PackagingNon-rinse, disposable, single use in plastic sachet5-g ointment tubePlastic bottle container 500 mL, sterile and non-pyrogenic
Dummy placeboIdentical placebo ointment tubeIdentical plastic sterile non-ionized patch sachetIdentical both placebo ointment tube and placebo plastic sterile non-ionized patch sachet
AdministrationWiping over PD catheter exit site after dressing with normal saline solution, then applying with placebo ointment base by participants or their caregivers, once daily.Daily applying to PD catheter exit site by participants or their caregivers after dressing with normal saline and wiping with placebo sterile non-ionized patch, respectivelyDaily dressing exit site with normal saline solution by participants or their caregivers, then wiping with placebo sterile non-ionized patch and applying with placebo ointment base, respectively
DurationOver a 24-month periodOver a 24-month periodOver a 24-month period
  1. Abbreviations: IMPs investigational medicinal products, PD peritoneal dialysis, USP the United States Pharmacopeia