Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.

Wound Infection Clinical Trial

Official title:

Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00150852
• Other study ID #: 04-012 (med 04-008)
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: December 28, 2005
• Start date: September 2004

Study information

• Verified date: September 2005
• Source: University Hospital, Geneva
• Contact: Alain Vonlaufen, MD
• Phone: +41 22 372 93 40
• Email: Alain.Vonlaufen[@]hcuge.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

Description:

Percutaneous endoscopic gastrostomy (PEG) provides an enteral route for long-term nutrition in patients unable to swallow. Peristomal wound infection occurs in 5 - 30 % of patients. Systematic antibiotic prophylaxis by cephalosporins or ampicillin/clavulanic acid has been shown to prevent this complication efficiently.

MRSA-positive patients have been suggested to be at higher risk of PEG-related wound infection due to MRSA. However, recommendations about vancomycin-prophylaxis before surgical procedures have not been extended to PEG insertion. This might be due to the fact that the exact route of contamination is unknown. It is assumed that contamination occurs when gastrostomy tubes are passed through the oropharynx. However, oropharyngeal carriage appears less frequent than nasopharyngeal or cutaneous carriage. Furthermore, patients who receive PEG are particularly vulnerable to vancomycin toxicity because of older age and multiple comorbidities.

The aim of this study is to compare the rate of infectious complications after PEG insertion in patients colonized with MRSA who received either standard intravenous antibiotic prophylaxis associated with vancomycin or standard prophylaxis with placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion

Exclusion Criteria:

• Age < 18 years

• No informed consent obtained either from the patient or from his legal representative

• Contraindication to the administration of cefazolin or of vancomycin

• Systemic administration of antibiotics effective against MRSA during the week prior to the procedure

• Technique of PEG insertion different from the standard pull technique proposed by the physician in charge and the gastroenterologist

• Patients requiring antibiotic prophylaxis of endocarditis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection

Intervention

Drug:
• Vancomycin

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire (CHU)	Grenoble
Switzerland	Division of Gastroenterology, University Hospital	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PEG-site infection at 3, 7, 14, 21 and 28 days post intervention as assessed by a clinical score (Jain score) and swab culture
Secondary	Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)