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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

Intervention

Chlorhexidine gluconate

Mupirocin ointment

Usual care with normal saline dressing

Description of IMPs

Non-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.)

Packaging

Non-rinse, disposable, single use in plastic sachet

5-g ointment tube

Plastic bottle container 500 mL, sterile and non-pyrogenic

Dummy placebo

Identical placebo ointment tube

Identical plastic sterile non-ionized patch sachet

Identical both placebo ointment tube and placebo plastic sterile non-ionized patch sachet

Administration

Wiping 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, respectively

Daily 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

Duration

Over a 24-month period

Over a 24-month period

Over a 24-month period

  1. Abbreviations: IMPs investigational medicinal products, PD peritoneal dialysis, USP the United States Pharmacopeia