Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG)

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. Identifier: NCT01237730
Recruitment Status : Unknown
Verified July 2010 by National Cheng Kung University.
Recruitment status was:  Recruiting
First Posted : November 10, 2010
Last Update Posted : November 10, 2010
Information provided by:
National Cheng Kung University

Brief Summary:
Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate

Condition or disease Intervention/treatment Phase
The Patients Who Receive Percutaneous Endoscopic Gastrostomy Peristomal Wound Infection After the Operation of PEG Prophylactic Antibiotics Before PEG Drug: cefuroxime Drug: Tailored antibiotic Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Oropharyngeal Microorganism Colonization on the Peristomal Infection After Percutaneous Endoscopic Gastrostomy and the Effect of Tailored Antibiotics Prophylaxis
Study Start Date : July 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Cefuroxime group
Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.
Drug: cefuroxime
Use the cefuroxime as prophylaxis.

Experimental: Tailored antibiotics group
Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.
Drug: Tailored antibiotic
Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.

Primary Outcome Measures :
  1. Peristomal wound infection [ Time Frame: Two weeks after operation of PEG ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients who receive PEG by pull method in our hospital, a tertiary transferring center, will be included

Exclusion Criteria:

  • The exclusion criteria for entry are inability to place the gastrostomy for technical reasons, such as oropharyngeal deformity or esophageal stricture. The patients who receive PEG by percutaneous push method will be excluded. The patients will be also excluded if active infection and fever are identified, and the PEG is delayed until the infection is brought under control.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01237730

Contact: chiao-hsiung chuang, M.D. 88662353535 ext 2679

National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: chiaohsiung chuang, M.D.    88662353535 ext 2679   
Principal Investigator: chiao-hsiung chuang, M.D.         
Sponsors and Collaborators
National Cheng Kung University
Study Director: chiao-hsiung chuang, M.D. National Cheng-Kung University Hospital

Responsible Party: National cheng kung university hospital, National cheng kung univeristy Identifier: NCT01237730     History of Changes
Other Study ID Numbers: NCKU-HR99
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: July 2010

Keywords provided by National Cheng Kung University:
percutaneous endoscopic gastrostomy
peristomal wound infection
prophylactic antibiotics

Additional relevant MeSH terms:
Wound Infection
Anti-Bacterial Agents
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents