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Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG)

Primary Purpose

The Patients Who Receive Percutaneous Endoscopic Gastrostomy, Peristomal Wound Infection After the Operation of PEG, Prophylactic Antibiotics Before PEG

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cefuroxime
Tailored antibiotic
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for The Patients Who Receive Percutaneous Endoscopic Gastrostomy focused on measuring percutaneous endoscopic gastrostomy, peristomal wound infection, prophylactic antibiotics

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cefuroxime group

Tailored antibiotics group

Arm Description

Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.

Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.

Outcomes

Primary Outcome Measures

Peristomal wound infection

Secondary Outcome Measures

Full Information

First Posted
November 9, 2010
Last Updated
November 9, 2010
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT01237730
Brief Title
Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy
Acronym
PEG
Official Title
Impact of Oropharyngeal Microorganism Colonization on the Peristomal Infection After Percutaneous Endoscopic Gastrostomy and the Effect of Tailored Antibiotics Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cheng Kung University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate
Detailed Description
Past know-how: Antibiotic prophylaxis has been shown to be effective to reduce peristomal infection.[9-11] The penicillin-or cephalosporin-based antibiotic prophylaxis are usually used with similar efficacy.[12] EuropeanSociety of Gastrointestinal Endoscopy (ESGE) guideline recommend that a single dose of intravenous cephalosporin orpenicillin as preparation before PEG.[17] The updated practice guidelines of American Society for Gastrointestinal Endoscopy (ASGE) and British Society of Gastroenterology (BSG) also recommend cefazolin or cefuroxime as prophylactic antibiotics.[18-19] Question: Is the 1st or 2nd generation cephalosporin is adequate as prophylactic antibiotics for percutaneous endoscopic gastrostomy (PEG)? Preliminary results: The leading two common pathogen to cause peristomal infection of PEG are P. aeuroginosa and methecillin-resistanced S. aurous. (Figure 1) These two common pathogen can't be covered by the prophylactic antibiotics which suggested by guideline. The patient with airway infection before PEG had higher peristomal infection rate, comparing with those without airway infection. Moreover, adequate antibiotics prophylaxis could significant improve the infection rate. (Table 1) Hypothesis: Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate. Specific aims: If individual tailored antibiotic prophylaxis according to throat swab could reduce the peristomal infection rate? If the phenotype and genotype analysis were compatible between infected wound isolates and throat swab/sputum isolates? If throat swab culture is better than sputum culture to predict peristomal infected microorganism? Is the infection is also linked to the oropharyngeal isolates if the patients get peristomal infection more than one week after PEG? Anticipated results: Individual tailored antibiotic prophylaxis according to the throat swab culture could reduce the peristomal infection rate of PEG and short the days of hospitalization. Most phenotype and genotype are compatible between peristomal isolates and throat swab/sputum isolates. It indicates that most pathogens are carried from throat into the peristomal to cause the infection. The microorganism isolated from throat swab could predict the pathogen of PEG peristomal infection. The throat swab culture may be better than sputum culture to predict the peristomal infected pathogen because some unconscious patients is difficult to collect sputum. Peristomal infection more than one week after PEG may be not associated to throat pathogen. It may be related to the contamination during wound care. Significances: This proposal result could be applied to clinical care of percutaneous endoscopic gastrostomy. The individual chose of prophylactic antibiotics could improve the peristomal infection rate. Currently, 1st or 2nd cephalosporin was usually recommended as prophylaxis before PEG. However, for the patient with ORSA culture from nasal cavity, vancomycin was suggested as prophylaxis because some studies support the benefit on infection prevention. If the results are positive, it may change the clinical guideline on antibiotics prophylaxis before PEG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Patients Who Receive Percutaneous Endoscopic Gastrostomy, Peristomal Wound Infection After the Operation of PEG, Prophylactic Antibiotics Before PEG
Keywords
percutaneous endoscopic gastrostomy, peristomal wound infection, prophylactic antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cefuroxime group
Arm Type
Active Comparator
Arm Description
Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.
Arm Title
Tailored antibiotics group
Arm Type
Experimental
Arm Description
Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.
Intervention Type
Drug
Intervention Name(s)
cefuroxime
Intervention Description
Use the cefuroxime as prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Tailored antibiotic
Intervention Description
Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.
Primary Outcome Measure Information:
Title
Peristomal wound infection
Time Frame
Two weeks after operation of PEG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chiao-hsiung chuang, M.D.
Phone
88662353535
Ext
2679
Email
chuang.chiaohsiung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chiao-hsiung chuang, M.D.
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chiaohsiung chuang, M.D.
Phone
88662353535
Ext
2679
Email
chuang.chiaohsiung@gmail.com
First Name & Middle Initial & Last Name & Degree
chiao-hsiung chuang, M.D.

12. IPD Sharing Statement

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Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy

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