Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00150852|
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : September 8, 2005
Last Update Posted : December 29, 2005
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection||Drug: Vancomycin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study|
|Study Start Date :||September 2004|
- 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
- Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150852
|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|
|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|
|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 email@example.com|
|Contact: Philippe De Saussure, MD + 41 22 372 93 40 Philippe.DeSaussure@hcuge.ch|
|Principal Investigator: Alain Vonlaufen, MD|
|Principal Investigator:||Alain Vonlaufen, MD||Division of Gastroenterology, University Hospital, Geneva|