The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions. Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population. Local infection is the most common complication following PEG. Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population. The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
90
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
Placebo
Department of Pediatrics
Rome, Italy
RECRUITINGEfficacy
24 hours after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system. PEG site infection will be defined as presence of pus or a score of 8 or more, with or without microbiological evidence of bacterial or fungal infection from PEG site swabs.
Time frame: 24 hours after PEG insertion
Efficacy
14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.
Time frame: 14 days after PEG insertion
Efficacy
Secondary outcomes are occurrence of systemic infection, defined as persistent fever (temperature \>38.0 °C for \>24 h) or clinical, laboratory and microbiological evidence of invasive sepsis and objective signs of infection, including a positive bacterial or fungal culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Time frame: 24 hours after PEG insertion
Efficacy
Secondary outcomes are occurrence of systemic infection, defined as persistent fever (temperature \>38.0 °C for \>24 h) or clinical, laboratory and microbiological evidence of invasive sepsis and objective signs of infection, including a positive bacterial or fungal culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Time frame: 14 days after PEG insertion
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