Infection
Conditions
Keywords
PEG, Percutaneous Endoscopic Gastrostomy, antibiotic prophylaxis
Brief summary
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.
Detailed description
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.
Interventions
DRUGco-amoxiclav
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Azienda Policlinico Umberto I
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit
Exclusion criteria
* Controindications for PEG * Ongoing antibiotic treatment * Antibiotic use within the past 4 days * Illness too severe to allow the patient to participate * Allergy to penicillin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 24 hours after PEG insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 24 hours after PEG insertion | 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. |
Countries
Italy
Outcome results
None listed