Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cheng Kung University.
Recruitment status was  Recruiting
Information provided by:
National Cheng Kung University
ClinicalTrials.gov Identifier:
First received: November 9, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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: 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 ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01237730

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

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
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 
Study First Received: November 9, 2010
Last Updated: November 9, 2010
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 26, 2016