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

Primary Purpose

Wound Infection

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Vancomycin

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring Gastrostomy, Wound infection, Antibiotic prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire (CHU)
Centre Hospitalier Universitaire Vaudois
Division of Gastroenterology, University HospitalRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)

Full Information

NCT ID

NCT00150852

First Posted

September 6, 2005

Last Updated

December 28, 2005

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT00150852

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Geneva

4. Oversight

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infection

Keywords

Gastrostomy, Wound infection, Antibiotic prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

96 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alain Vonlaufen, MD

Phone

+41 22 372 93 40

Alain.Vonlaufen@hcuge.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe De Saussure, MD

Phone

+ 41 22 372 93 40

Philippe.deSaussure@hcuge.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alain Vonlaufen, MD

Organizational Affiliation

Division of Gastroenterology, University Hospital, Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire (CHU)

City

Grenoble

ZIP/Postal Code

38000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnès Plages

Phone

+ 33 476 76 55 97

APlages@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Xavier Roblin, MD

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gian Dorta

Phone

+ 41 21 314 11 11

Gian.Dorta@chuv.ch

First Name & Middle Initial & Last Name & Degree

Gian Dorta, MD

Facility Name

Division of Gastroenterology, University Hospital

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain Vonlaufen, MD

Phone

+ 41 22 372 93 40

alain.vonlaufen@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Philippe De Saussure, MD

Phone

+ 41 22 372 93 40

Philippe.DeSaussure@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Alain Vonlaufen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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