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Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by National Cheng Kung University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237730
First Posted: November 10, 2010
Last Update Posted: November 10, 2010
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.
Information provided by:
National Cheng Kung University
  Purpose
Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate

Condition Intervention
The Patients Who Receive Percutaneous Endoscopic Gastrostomy Peristomal Wound Infection After the Operation of PEG Prophylactic Antibiotics Before PEG Drug: cefuroxime Drug: Tailored antibiotic

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cheng Kung University:

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

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01237730


Contacts
Contact: chiao-hsiung chuang, M.D. 88662353535 ext 2679 chuang.chiaohsiung@gmail.com

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

Responsible Party: National cheng kung university hospital, National cheng kung univeristy
ClinicalTrials.gov Identifier: NCT01237730     History of Changes
Other Study ID Numbers: NCKU-HR99
First Submitted: November 9, 2010
First Posted: November 10, 2010
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:
Infection
Wound Infection
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents