Clinical trial NCT01237730: Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

1. 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.
2. 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:

1. If individual tailored antibiotic prophylaxis according to throat swab could reduce the peristomal infection rate?
2. If the phenotype and genotype analysis were compatible between infected wound isolates and throat swab/sputum isolates?
3. If throat swab culture is better than sputum culture to predict peristomal infected microorganism?
4. Is the infection is also linked to the oropharyngeal isolates if the patients get peristomal infection more than one week after PEG?

Anticipated results:

1. Individual tailored antibiotic prophylaxis according to the throat swab culture could reduce the peristomal infection rate of PEG and short the days of hospitalization.
2. 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.
3. 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.
4. 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.

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.

Primary outcomes:
measure: Peristomal wound infection
timeFrame: Two weeks after operation of PEG
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: chiao-hsiung chuang, M.D.
role: STUDY_DIRECTOR
References: