NCT01870167

Antibiotic Prophylaxis for PEG in Children

Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
DRUG	co-amoxiclav	a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-06-05
• Last updated: 2013-06-05

Locations

1 site across 1 country: Italy