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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Geneva. Recruitment status was Recruiting

First Received on September 6, 2005. Last Updated on December 28, 2005 History of Changes

Sponsor:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00150852

Purpose

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).

Condition	Intervention	Phase
Wound Infection	Drug: Vancomycin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study

Resource links provided by NLM:

Drug Information available for: Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

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)

Estimated Enrollment:	96
Study Start Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150852

Contacts

Contact: Alain Vonlaufen, MD	+41 22 372 93 40	Alain.Vonlaufen@hcuge.ch
Contact: Philippe De Saussure, MD	+ 41 22 372 93 40	Philippe.deSaussure@hcuge.ch

Locations

France
Centre Hospitalier Universitaire (CHU)	Not yet recruiting
Grenoble, France, 38000
Contact: Agnès Plages + 33 476 76 55 97 APlages@chu-grenoble.fr
Principal Investigator: Xavier Roblin, MD
Switzerland
Centre Hospitalier Universitaire Vaudois	Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Gian Dorta + 41 21 314 11 11 Gian.Dorta@chuv.ch
Principal Investigator: Gian Dorta, MD
Division of Gastroenterology, University Hospital	Recruiting
Geneva, Switzerland, 1211
Contact: Alain Vonlaufen, MD + 41 22 372 93 40 alain.vonlaufen@hcuge.ch
Contact: Philippe De Saussure, MD + 41 22 372 93 40 Philippe.DeSaussure@hcuge.ch
Principal Investigator: Alain Vonlaufen, MD

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Alain Vonlaufen, MD

Division of Gastroenterology, University Hospital, Geneva

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00150852 History of Changes
Other Study ID Numbers:	04-012 (med 04-008)
Study First Received:	September 6, 2005
Last Updated:	December 28, 2005
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Gastrostomy
Wound infection
Antibiotic prophylaxis

Additional relevant MeSH terms:

Wound Infection
Staphylococcal Infections
Infection
Wounds and Injuries
Gram-Positive Bacterial Infections
Bacterial Infections

Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012