Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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placebo
Placebo
Placebo
Placebo
co-amoxiclav
co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor
co-amoxiclav
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
Interventions
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co-amoxiclav
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Ongoing antibiotic treatment
* Antibiotic use within the past 4 days
* Illness too severe to allow the patient to participate
* Allergy to penicillin
1 Month
18 Years
ALL
No
Sponsors
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Azienda Policlinico Umberto I
OTHER
Responsible Party
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Giovanni Di Nardo
MD
Locations
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Department of Pediatrics
Rome, , Italy
Countries
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Facility Contacts
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Other Identifiers
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Pediatric- PEG
Identifier Type: -
Identifier Source: org_study_id
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