Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT01870167
Status:
UNKNOWN
Last Update Posted:
2013-06-05
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis for PEG in Children
Sponsor:
Azienda Policlinico Umberto I
Organization:
Study Overview
Official Title:
Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: